<<

The Creation and Validation of the Dynamic Injury Screening Tool for the Lower

Extremity (DISTLE)

A thesis presented to

the faculty of

the College of Health Sciences and Professions of Ohio University

In partial fulfillment

of the requirements for the degree

Master of Science

Christine O. Samson

May 2014

© 2014 Christine O. Samson. All Rights Reserved.

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This thesis titled

The Creation and Validation of the Dynamic Injury Screening Tool for the Lower

Extremity (DISTLE)

by

CHRISTINE O. SAMSON

has been approved for

the School of Applied Health Sciences and Wellness

and the College of Health Sciences and Professions by

Brian G. Ragan

Assistant Professor of Health Sciences and Wellness

Randy Leite

Dean, College of Health Sciences and Professions 3

Abstract

SAMSON, CHRISTINE O., M.S., May 2014, Athletic Training

The Creation and Validation of the Dynamic Injury Screening Tool for the Lower

Extremity (DISTLE)

Director of Thesis: Brian G. Ragan

Context: The healthcare needs of special populations have been met with the application of telemedicine. Running related injuries (RRIs) are frequent among the running population in which clinician conducted gait assessments to identify gait abnormalities are not easily accessible. To increase accessibility of clinician conducted gait assessments, a system was developed with a telemedicine approach. Objective: To determine clinical importance, viewing parameters, and the reliability of clinicians to identify gait abnormalities to develop the Dynamic Injury Screening Tool for the Lower

Extremity (DISTLE). The use of DISTLE was then validated. Participants: The participants were currently licensed and practicing athletic trainers. Other participants included physically active volunteers who served as walkers and standardized patients for the third and fourth phases, respectively. Conclusions: The cumulative results display a need for standardization of observation gait assessments and video parameters prior to the application of a telemedicine approach to address the running population’s needs. 4

Dedication

Challenges are what make life interesting;

Overcoming them is what makes life meaningful.

-Ralph Waldo Emerson

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Acknowledgments

I would like to thank my thesis advisor Dr. Brian Ragan for his hard work and dedication to my progress throughout the entire process. The second, third, and fourth phases would not have been possible without the patience, cooperation, and assistance of my fellow graduate classmates. I greatly appreciate the generous funding from the

College of Health Sciences and Professions Student Grant that promoted the successful completion of my third and fourth phases. The use and disbursement of funds would not have been possible without the patience and guidance of Jane Boney. Special thanks to Mr. Tedd Girouard and all of the athletic trainers associated with the University of Nevada, Las Vegas (UNLV) Athletic Training Education Program for serving as a second data collection site on multiple occasions. Additionally I would like to extend my deepest gratitude to my thesis committee: Dr. Andrew Krause, Dr. Jason White, and Ms.

Christina Orozco.

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Table of Contents Page

Abstract ...... 3 Dedication ...... 4 Acknowledgments...... 5 List of Tables ...... 8 List of Figures ...... 9 Chapter 1: Introduction ...... 10 Significance ...... 12 Purpose ...... 12 Specific Aims ...... 13 Research Questions ...... 13 Chapter 2: Literature Review ...... 14 Popularity of Running ...... 14 Normal Gait Patterns ...... 15 Observable Gait Abnormalities ...... 20 Running Related Injuries ...... 24 Current Gait Assessment Methods ...... 25 Current Clinical Evaluation Tests for Lower Extremity Pathologies ...... 29 Telemedicine ...... 30 Summary ...... 34 Chapter 3: Methods ...... 36 Phase I: Identification of Gait Abnormalities in Literature ...... 38 Phase II: Clinical Relevance ...... 38 Phase III: Establishing Reliability for Video Medium ...... 40 Phase IV: Validating DISTLE ...... 42 Chapter 4: Results ...... 47 Phase I: Identification of Gait Abnormalities ...... 47 Phase II: Clinical Relevance ...... 49 Phase III: Establishing Reliability for Video Medium ...... 52 Phase IV: Validating DISTLE ...... 59 7

Chapter 5: Discussion ...... 68 Lack of Gait Assessment Standardization ...... 68 Telemedicine: Store and Forward Approach ...... 71 Experience of Clinician ...... 73 Limitations ...... 74 Significance ...... 75 Future Research ...... 76 Conclusion ...... 77 References ...... 79 Appendix A-1: GACIS Recruiting Email ...... 89 Appendix A-2: GACIS Form ...... 90 Appendix A-3: Gait Abnormalities: Clinical Importance Survey ...... 92 Appendix B-1: ROGAT Volunteer Walker Photo/Video Release ...... 97 Appendix B-2: ROGAT Volunteer Walker Physical Examination Chart ...... 98 Appendix B-3: ROGAT Recruiting Email ...... 100 Appendix B-4: ROGAT Consent Form ...... 101 Appendix B-5: ROGAT Educational Training Session PowerPoint ...... 104 Appendix B-6: ROGAT Sample Questions ...... 110 Appendix C-1: DISTLE Standardized Patient Photo/Video Release ...... 113 Appendix C-2: DISTLE Survey Portion ...... 114 Appendix C-3: DISTLE Standardized Patient Physical Examination Chart ...... 118 Appendix C-4: DISTLE Recruiting Email ...... 120 Appendix C-5: DISTLE Participant Screening Survey (Screenshot) ...... 121 Appendix C-6: DISTLE Consent Form ...... 122 Appendix C-7: DISTLE Educational Training Session PowerPoint ...... 125 Appendix C-8: DISTLE Sample Questions ...... 129

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List of Tables

Page

Table 1-A. Joint Kinematics Throughout the Stance Phase of Walking Gait ...... 18

Table 1-B. Joint Kinematics Throughout the Swing Phase of Walking Gait ...... 19

Table 2. Relationship Between Static and/or Dynamic Alignment and Injury...... 21

Table 3. Forty Gait Abnormalities Identified in the Phase I ………………………...... 48

Table 4. Phase II: Clinical Importance Mean for Gait Abnormalities…………………50

Table 5. Phase II: Viewing Parameters for Clinically Important Gait Abnormalities ....51

Table 6. Phase III: Frequency of Gait Assessments by Participants...... 52

Table 7. Phase III: Reliability of Identifying Gait Abnormalities ...... 54

Table 8. Phase III: Validity of Abnormality Identification and Physical Exam ...... 56

Table 9-A. Phase III: Validity Results for > 5 Years of Experience ...... 58

Table 9-B. Phase III: Validity Results for < 5 Years of Experience...... 59

Table 10-A. Phase IV: Participant Demographics by Years of Experience ...... 60

Table 10-B. Phase IV: Participant Demographics by DISTLE Version ...... 60

Table 11. Phase IV: Interrater Reliability Based on Subgroups ...... 61

Table 12. Phase IV: Interrater Reliability for Gait Abnormalities ...... 62

Table 13. Phase IV: Validity of Abnormality Identification and Physical Exam ...... 63

Table 14. Phase IV: Validity Results for Group Receiving Full Version of DISTLE ....64

Table 15. Phase IV: Validity Results for No Survey Version of DISTLE Group ...... 65

Table 16. Phase IV: Validity Results with Greater Than 5 Years of Experience ...... 66

Table 17. Phase IV: Validity Results with Less Than 5 Years of Experience ...... 67 9

List of Figures

Page

Figure 1: One gait cycle ...... 15

Figure 2: Flowchart of the phases for this study ...... 37

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Chapter 1: Introduction

Telemedicine is an innovative field of medicine providing patients access to consultations with specialists in different geographical locations thanks to the advances in technology.1,2 The benefits of telemedicine for patients include: access to medical resources and specialists not readily available for consultation; a decrease in travel time and expenses; a decrease in loss of time at work; and a decrease loss of leisure time.3

Target patient demographics for telemedicine include isolated and rural areas in addition to special populations requiring extensive monitoring. Physically active populations, such as runners, could benefit from direct access to clinician conducted exams via a telemedicine approach instead of attempting to locate local businesses providing quality gait assessments.

Running is considered to be one of the most popular outdoor activities with over

50 million American runners.4 The popularity of running can be attributed to its accessibility and associated health benefits. Because running does not require the purchase or use of expensive equipment or a specific location, it is accessible to anyone.

The associated health benefits of regular running include: increased physical fitness,5 decreased body weight,6 decreased body fat,6 decrease in risk factors for cardiovascular diseases,7 increased cardiorespiratory fitness,6 and increased self-esteem.8 Although the benefits of running are plentiful, there are some injury risks associated with any type of physical activity, running included.

The ability to accurately measure the incidence of running related injuries (RRI) to the lower extremity is difficult, resulting in a wide range of RRI incidence rates in the

11 literature varying from 28 to 79 for every 100 long distance runners.9-11 Chronic injuries such as tendinopathies and stress fractures, and acute injuries such as ligament sprains and muscular strains, are the most common reported RRIs experienced by long distance runners.12 RRIs are associated with training errors, abnormal anatomical structure, environmental factors, or a combination of these factors.5 RRIs have also been associated with an alteration in gait patterns, which can cause or exacerbate RRIs.13-16

One would suspect, of the millions of runners affected by RRIs, that a large portion would have at least one gait abnormality. Gait abnormalities are deviations in joint motion from the established norm throughout the gait cycle. As running duration and frequency increase, muscular imbalances and/or the loss of flexibility can change running gait. Gait abnormalities can be addressed with the implementation of the correct strengthening and/or stretching program. A clinician is able to identify the muscular imbalances and changes in flexibility through a physical examination.17 With respect to gait assessment, the common, more practical method used by clinicians is an in-person clinical observational gait assessment as compared to the more complex and expensive motion analysis often found in research laboratories. In order to provide runners with the ability to address gait abnormalities with the intent of preventing or reducing the frequency of RRIs, a gait assessment by a clinician needs to become more readily accessible.

If a system can be built to reliably assess gait abnormalities present in a patient’s uploaded video then increased accessibility to clinician conducted gait assessments for

12 runners can occur. This system would provide runners with the convenience of completing the gait assessment wherever and whenever it is convenient for them.

Significance

Technological progress has allowed the previously impossible to become convenient and practical; for example, a gait assessment of a patient conducted by a clinician on the opposite side of the country. Successful telemedicine systems for diagnosis and remote monitoring are utilized daily to provide optimal healthcare to patients.1,18 American recreational runners consist of a large population who are at risk for injuries and who do not have direct access to clinicians capable of identifying and addressing the gait abnormalities that cause pain and injury.4,5,12 This research attempts to use an online platform to increase the accessibility of runners to clinicians who can assess gait abnormalities of runners regardless of geographic location. The Dynamic Injury

Screening Tool for the Lower Extremity (DISTLE) would provide runners access to a clinician’s feedback and recommendations regarding gait abnormalities. The potential impact of DISTLE could over time decrease the frequency of RRIs in the running population and, in turn, decrease the medical consultations and expenses, related travel expenses, and lost running time which will allow runners to do what they enjoy most— run.

Purpose

The purpose of this thesis was to develop and validate a video system, DISTLE, to be used through an online platform to provide access to gait assessments for runners who desire an assessment of gait abnormalities.

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Specific Aims

1. Develop a video gait screening tool, DISTLE, to identify gait abnormalities

that may predispose those who are physically active to injury.

2. Establish evidence of validity for the developed video gait screening tool,

DISTLE, by comparing video observational gait analysis to a physical

examination.

Research Questions

1. Can clinicians identify which gait abnormalities are important to observe

during a gait assessment?

2. Can clinicians correctly identify specific gait abnormalities of patients in a

recorded video?

3. Can clinicians develop a comprehensive assessment of patients’ running

related problems based on video alone or is it necessary to provide both video

and subjective information relevant to patients’ complaints?

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Chapter 2: Literature Review

The review of literature provides a background for this study and includes a description of normal gait patterns, abnormal gait patterns, running related injuries, modes of gait assessment, clinical evaluations, telemedicine, and the need for a technologically advanced lower extremity screening tool for the physically active.

Popularity of Running

Running is one of the most popular outdoor activities, with over 50 million

American participants in 2010, a 13% increase from 2009.4 There are no gym memberships or special equipment required for an individual to run, making it universally accessible. Running can be an individual competitive event, a fundamental skill used in team sports, and/or a lifestyle choice for those maintaining a physically active lifestyle. Individuals can train and compete as a marathon, long distance, or short distance runner based on their level of experience. As a fundamental skill, running is used by team sports with rapid changes in direction and speed or in the form of sprints during general play or preseason conditioning.19

The associated health benefits from running. Various health benefits are associated with running for those who choose to use running as an exercise modality to remain physically active.5,20,21 Decreased body weight, decreased body fat percentage, weight control over long periods of time, and decreased circumferences of the waist, hip, and chest have all been observed to be inversely related to runners’ mileage per week.22,23

In addition to increased cardiorespiratory fitness, the following risks have been observed to decrease due to increased metabolic equivalent energy expenditures per day through

15 running: hypertension, hypercholestremia, diabetes mellitus, and coronary heart disease.7

Along with the improvement of physical health, mental health benefits such as better self- image and smoking cessation have been observed among those who choose to run recreationally.24,25

Normal Gait Patterns

The basic unit of measure used within a gait assessment is a gait cycle, defined as the moment from one foot contacting the ground until the next moment the same foot contacts the ground a second time.26 One gait cycle consists of a swing phase and a stance phase, illustrated in Figure 1.

Figure 1. One gait cycle.

Stance phase. The stance phase occurs when the limb progresses through contact with the ground. The five subdivisions of the stance phase include: initial contact, loading response, midstance, terminal stance, and preswing.27,28 The joint kinematics of the lower extremity during each of the five subdivisions are discussed in Table 1-A. Initial contact is defined as the first contact of the heel and/or foot with the ground.27,28 Loading response begins after initial contact and continues until the opposite foot is lifted for

16 swing.27 Midstance is defined as when single limb support occurs as the knee and hip joints are aligned over the foot and ankle.27,28 Terminal stance begins when the heel of the contact limb rises off the ground and continues until the opposite foot makes contact with the ground.27,28 Preswing is the final subdivision of the stance phase, which begins with initial contact of the opposite limb until the toe of the contact limb leaves the ground.27,28

Swing phase. The swing phase occurs with the forward advancement of the limb.

The three subdivisions of the swing phase include: initial swing, midswing, and terminal swing.26,27 The joint kinematics of the lower extremity during each of the three subdivisions are discussed in Table 1-B. Initial swing begins after the toe is lifted from the ground in preswing and continues until the swinging limb is opposite the stance limb.27 Midswing begins with the conclusion of initial swing and continues until the tibia of the swing limb is vertical and anterior in relation to the stance limb.27 Terminal swing begins with the tibia vertical from midswing and concludes the swing phase when the foot of the swing limb strikes the ground.27

Comparison of walking and running characteristics. There is a period of transition between the stance and swing phases in which both limbs are in contact with the ground during walking gait.26,29 The two periods of double support occur at the beginning and end of the stance phase.26,29 The walking gait cycle composition is 60% stance phase and 40% swing phase.29 In contrast, with running there is a period of transition between the stance and swing phases in which there is no limb in contact with the ground, this is referred to as the float phase.29 The float phase occurs twice throughout the gait cycle, at the beginning and end of the swing phase.26 The swing phase

17 accounts for more than 50% of the running gait cycle, due to the double float phase in which both limbs are in the swing phase.29 There is an indirect relationship between velocity and the length of the stance phase. As velocity increases, the amount of time spent in stance phase decreases.29

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Table 1-A. Joint Kinematics Throughout the Stance Phase of Walking Gait

Subtalar Talocrural Knee Hip

Initial Supination Neutral or slightly PF 0° flexion: tibia 30° flexion: femur Contact moving in PF motion externally rotated externally rotated

Loading Pronation Reaches max of 7° PF 20° flexion: tibia 30° flexion: femur Response internally rotates, tibia internally rotating to begins to externally neutral rotate as knee extends

Midstance Pronation, Max of 15° DF as lower 20° flexion to 0°: tibia 25° flexion to 0° supinating leg moves anteriorly over externally rotating flexion: femur towards neutral foot internally rotated and abducted 5°

Terminal Supination DF moving toward PF 5° flexion to 0°: tibia 0°-10° extension: Stance externally rotates femur externally rotates and adducts

Preswing Supination PF 0°-40° flexion: tibia 20° extension to 0° externally rotates extension: femur externally rotates with slight abduction Abbreviations: PF, plantarflexion; DF, dorsiflexion; max, maximum. Kinematic measurements reference: Starkey C, Brown SD, Ryan J. Examination of orthopedic and athletic injuries. 3rd ed. FA Davis Co; 2009.

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Table 1-B. Joint Kinematics Throughout the Swing Phase of Walking Gait

Subtalar Talocrural Knee Hip

Initial Swing Pronating Reaches max of 20° 30°-70° flexion: 0°-20° flexion: rapid DF for toe tibia internally femur externally clearance rotates rotates

Midswing Neutral Neutral 30°-0° flexion: tibia 20°-30° flexion: externally rotates femur externally rotates

Terminal Swing Supination Neutral 0°: tibia externally 30° flexion: femur rotates externally rotates

Abbreviations: PF, plantarflexion; DF, dorsiflexion; max, maximum. Kinematic measurements reference: Starkey C, Brown SD, Ryan J. Examination of orthopedic and athletic injuries. 3rd ed. FA Davis Co; 2009.

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Observable Gait Abnormalities

A multitude of possible gait abnormalities can occur, characterized by increases or decreases of expected motion that are observable in the frontal or sagittal planes.

Limited numbers of studies assess the relationship between RRIs and anatomical (static) or gait (motion) abnormalities. Hip and foot abnormalities are reported frequently, emphasizing the significance of excessive hip internal rotation.13,14 Gait abnormalities of the foot and ankle such as excessive supination and excessive pronation are frequently associated with anatomic anomalies.15,16,30,31 Table 2 identifies the prospective, retrospective, and cross-sectional studies evaluating the presence of static and/or dynamic anatomical abnormalities commonly associated with the presence of certain gait abnormalities.

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Table 2. Relationship Between Static and/or Dynamic Alignment and Injury

Probable Associated Type of Study Participants Significant Findings Gait Abnormalities

Hip Wen et al32 Prospective 355 participants Higher association of injury Hip hiking enrolled in 32 week with: higher tubercle-sulcus marathon training angle and knee varus; low leg program length difference

Zifchock et al13 Retrospective 40 runners, 20 Increase of hip internal Excessive hip internal participants with prior rotation range of motion and rotation history of an overuse peak tibial acceleration on the unilateral injury injured limb; Bilateral increase in hip internal rotation and deviation from the normal arch height index among injured runners

Souza et al14 Cross-sectional 38 females, 19 with Greater average of hip Excessive hip internal study patellofemoral pain and internal rotation during first rotation 19 pain-free 50% of stance phase while running for the patellofemoral pain group.

Knee You et al33 Cross-sectional 22 participants with Greater hip and knee flexion Vaulting study gastrocnemius tightness angles found with maximum inadequate hip flexion dorsiflexion in the tightness inadequate knee group. flexion

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Table 2. Relationship Between Static and/or Dynamic Alignment and Injury (Continued)

Probable Associated Type of Study Participants Significant Findings Gait Abnormalities

Foot Kaufman et al30 Prospective 449 naval trainees Risk factors identified to Excessive hindfoot predispose lower extremity supination overuse injury: pes planus, pes cavus, restricted ankle dorsiflexion, and increased hindfoot inversion

Williams III et Non-randomized 22 high arched and 20 Greater incidence of ankle, Excessive supination al31 survey low arched runners bony, and lateral injuries or lateral contact associated with high-arched excessive pronation or runners. Greater incidence of medial contact knee, soft tissue, and medial injuries with low-arched runners

Simpson et al34 Cross-sectional 30 females Greater excessive Excessive toe-out study mediolateral forces by toe-out participants.

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Table 2. Relationship Between Static and/or Dynamic Alignment and Injury (Continued)

Probable Associated Type of Study Participants Significant Findings Gait Abnormalities

Foot Willems et al16 Prospective 400 physical education Those who developed Excessive pronation students exercise-related lower leg or medial contact pain (ERLLP) showed a significant increase in pronation and increased abduction excursion. The injury group experienced significantly delayed timing of maximal eversion and increased mean and maximal reinversion velocity. Significant increased higher medial displacement during initial contact developed ERLLP.

Other Lun et al10 Prospective 69 recreational runners Different between injured and noninjured runners: right ankle dorsiflexion, right knee genu valgum, and left forefoot varus

24 Running Related Injuries

RRIs can be caused by factors, alone or in combination: training errors, anatomical structure, or the environment.5 Multiple definitions exist for what constitutes a RRI. Generally, a RRI can be defined as any musculoskeletal pain experienced during or after running that decreases the capability of runners to train or compete at their normal level, or prevents them from completing a training session.20,35

Running injury epidemiology. The overall incidence of RRIs to the lower extremity, observed solely for long distance runners since the year 2000, varies from 28 to 79 injuries per 100 runners.9-11 Prevalence differs between novice and elite level runners. The incidence of RRIs for novice runners is between 30.1 and 33 injuries per

1000 hours of running exposure.5,21 The incidence of RRIs for marathon runners is 2.5 to

7.4 injuries per 1000 hours of running exposure.21 Overuse soft tissue injuries have an incidence rate of 37.4 per 1000 hours of running exposure for elite team sport athletes.19

Those participating recreationally may be unaware of the significance of certain aches and pains; one in five recreational runners continue to participate in events with the presence of RRI symptoms.36 By continuing to participate with the RRI symptoms, recreational runners can further exacerbate their overuse injuries. Of the RRIs experienced, 50%-70% are overuse injuries anatomically located at or distal to the knee.5,37,38 The most common injuries associated with long distance runners include:

Achilles Tendinopathy, Medial Tibial Stress Syndrome, Iliotibial Friction Syndrome, and stress fractures.12 The knee, however, is the most predominant site in the lower extremity for a RRI.5,20

25 Complications. The complications associated with RRIs include financial cost, decreased performance, and the loss of practice and/or competition time.12 Health care visits, physical therapy, orthotics, and other treatment interventions contribute to the financial cost of RRIs. Once an individual has sustained a RRI, it may present a challenge to restart running once the injury has resolved or healed to a state that would allow running to resume. After sustaining a RRI, 39 of 98 (40%) female and 24 of 65 (37%) male runners did not resume running.5 Novice runners have a significantly greater chance of not restarting a running program after sustaining a RRI when compared to those who run on a regular basis.5

Current Gait Assessment Methods

Numerous instruments and methods are available for clinicians and researchers to use as a mode of gait assessment for normal and abnormal gait patterns. The instruments range in complexity of set up, system parameters, time commitment, and financial cost.

Kinematic systems. Kinematics is the measurement of joint displacement, or movement, with respect to linear and angular velocity and acceleration.39 Kinematic systems use either two or three dimensional analysis of joint angles to calculate the corresponding kinematic measurements.39 There are multiple camera systems that require the use of two or more video cameras to provide varying fields of view for analysis.39

Anatomical markers are applied to the patient to allow the simultaneous collection of sagittal, coronal, and transverse joint measurements.27,39 Measurement errors are plausible depending on clinicians’ placement of the anatomical markers and the amount of skin movement that occurs around a joint to accommodate varying degrees of motion.39,40 There is poor kinematic measurement agreement between the bone and skin

26 markers for abduction/adduction and internal rotation/external rotation.40 Therefore, skin markers provide kinematic representation of skeletal movement for flexion/extension.

The use of such systems is limited by associated expenses, sophisticated equipment, length of instrument preparation, instrument application by clinicians, and confinement to a laboratory setting.41

Dynamic electromyography. Dynamic electromyography (EMG) is the measurement of electrical activity within a contracting muscle while the patient is walking.39 The EMG signals, measured by electrodes, cannot distinguish between isometric, concentric, and eccentric contractions, but are recorded as numerical values.27,39 The activation and measurement of sustained contractions of targeted muscles throughout the gait cycle can be obtained. Timing and/or intensity of the EMG record may be altered at a particular phase or throughout the entire gait cycle in the presence of a gait abnormality.27 The challenges associated with EMG use for gait analysis include: vague indication of actual strength of muscle contraction, usage confined to a clinic or laboratory setting, and cost of the equipment.27

Direct motion measurement systems. There are multiple gait analysis methods classified as direct motion measurement systems. These systems require a measuring device that is directly applied to the patient in order to measure the amount of motion occurring at a specific segment of the limb as a whole.39 The number of axes or limb motions measured depends on the complexity of the system.39 The temporal and distance parameters of gait are more commonly analyzed with systems located in research rather than clinical settings due to the cords configured to collect data.39

27 Electrogoniometers. An electrogoniometer is an instrument that continually measures the various angles of a joint during motion.39 The measurements can be plotted as one joint angle measurement over time, or as the interaction of two different joint angles occurring simultaneously.39 The instrument, first developed for knee measurement, is primarily strapped to the lateral aspect of the limb.27,39 Angle measurements of one joint are possible in one plane using single axis parallelogram electrogoniometers, or in multiple planes using the triaxial parallelogram goniometers.27

Accuracy of the angle measurement may depend on the comfort of the instrument application to the patient, alignment with the anatomical axis of the joint, or the displacement of sensors with motion.27,39 Despite the expense, electrogoniometers are one of the gait analysis instruments considered to be convenient for joint angle measurements that require a simple recorder to output data immediately.27

Force platforms or “forceplates.” Ground reaction force, location of pressure on the plantar surface of the foot, and the center of pressure throughout the stance phase are measured by the force exerted upon a force platform as a patient walks across.39,42 Force platforms are often embedded into the ground within a laboratory, constraining the clinician to laboratory use only. Other constraints associated with use of the force platforms include: ground reaction forces can be analyzed for only one step at a time due to the surface area of the platform; sensitivity to building vibrations and those in close proximity to the platform; decrease in effectiveness without recalibration; and the need for step precision onto the platform to ensure good data are obtained.39,42,43 This instrument measures one aspect, the pressures accepted and distributed by the foot during the stance phase of gait.

28 Instrumented walkways. Instrumented walkways have pressure sensors embedded within a carpeted electronic walkway connected to a computer.27,44 The

GAITRite system is one example of an instrumented pathway. Test-retest measurements of spatial and temporal parameters have been shown to be highly reliable with the

GAITRite system.44 However, the GAITRite system is a large financial investment for clinicians. The instrument requires a large amount of physical space and is not likely to be used on a routine basis.44

Accelerometers. Accelerometers measure the amount of spring deflection that occurs when the connected mass within the device is accelerated in one particular direction.39 Accelerometers are primarily used to measure events defined by short bursts of high acceleration and limb segment motion throughout a phase during the gait cycle.39

This small compact instrument is easy for clinicians to apply and comfortable for patients to wear during gait analysis. The application and fastening measures used to secure accelerometers to the body may pose the challenge of adequately representing actual limb movements.39

Observational gait analysis. Observational gait analysis is a subjective measure completed by the clinician’s unaided eye, or recorded for permanent documentation and unlimited review by the clinician via video camera. With an in-person visual analysis, it is not uncommon to have the patient observed by the clinician from different locations as the patient walks a specified distance multiple times.39 The recording of a patient’s gait allows the clinician to assess gait multiple times without inflicting fatigue upon the patient, and to maintain full control over the speed and width of the frame in which an abnormality may be assessed.39 The abnormalities each clinician observes during an

29 observational gait analysis depends on the education, training, and bias of clinical importance.45 A higher frequency of interrater errors to intrarater inconsistency of observed abnormalities of recorded gait assessments has been observed among three trained and experienced raters using a 3-point scale.45 Reasonable reliability for visual gait analysis is obtained when using a structured form listing the gait abnormalities to be assessed.46 Although this method of gait analysis is the least expensive and most convenient for clinicians to use, the accuracy of the gait analysis depends on the amount of training and observer error demonstrated by the clinician.45

Current Clinical Evaluation Tests for Lower Extremity Pathologies

There are clinical evaluation tests presently used by clinicians to evaluate aspects of static and dynamic alignment during a physical examination of the lower extremity.

The following tests have been identified with evaluating static or dynamic anatomical alignment that may be associated with certain gait abnormalities.

Arch index. The clinician measures arch index with the patient weight bearing barefoot. The arch index is a ratio of the height of the navicular tubercle from the ground to the length of the medial aspect of the foot.47 The length of the medial aspect of the foot is measured from the first metatarsophalangeal joint to the posterior aspect of the calcaneus.47 The use of the arch index is an objective measure to assist with the classification of foot type.

Navicular drop. The clinician measures the amount of inferior displacement of the navicular tubercle from a seated, nonweight bearing position to a standing equally distributed weight-bearing position.48 The change in inferior displacement is measured from the initial and final marks, parallel to the navicular tubercle, recorded on a piece of

30 paper. If the displacement of the navicular is greater than or equal to 10mm, it is considered to be a positive finding for which intervention may be necessary.49 Positive findings may replicate pronation of the subtalar joint or the collapse of the medial longitudinal arch.48 The navicular drop test has been reported with a poor interrater reliability and moderate to good intrarater reliability.50-52

Trendelenburg test. The Trendelenburg test assesses the functionality of the hip abductors.53 The clinician observes the patient’s iliac crests as the unaffected limb is lifted. The pelvis of the nonweight bearing side will lower indicating weakness of the gluteus medius. Validity, significance, and reliability for the test are unclear in the literature.17

Functional test of hip abductors and hip external rotators. The observation of hip internal rotation and/or an increase in dynamic valgus at the knee may reflect a lack of strength of the hip abductors or hip external rotators.54 The patient is instructed to slowly descend forward from the top of a step stool with the uninjured limb leading. The clinician observes for the patella aligning medial to the great toe, which would reflect a change in the angle of dynamic valgus and/or hip internal rotation during the descent.54

Validity and reliability measures for this functional assessment were not found in the literature.

Telemedicine

The increased use of technology in the completion of medical tasks is directly related to technological advances over the past decades. The exact definition of telemedicine is broad. It is considered to be a system of healthcare using technological mediums to substitute the need for healthcare professionals to be in the same geographic

31 location as their patients or other consulting professionals.1,2 Telemedicine has been incorporated into clinical areas, public health, and medical education.1 More commonly used in rural locations and developing countries, telemedicine provides healthcare professionals a broad network of contacts not readily available for collaboration in regards to diagnostic or treatment procedures for patients.55,56

There are two modes of operation for telemedicine systems: real-time and store- and-forward.18 The simultaneous interaction between clinician and patient is considered to be real-time. In contrast, store-and-forward requires patients or referring clinicians to record or photograph what is to be sent to and evaluated by specialists at a later time.

Telemedicine provides access to healthcare when and where convenient. A decrease in travel time and expenses, loss of work, and loss of leisure time are appealing assets of telemedicine, in addition to improved access to specialists by healthcare professionals from remote locations.3

Common uses. Due to the definition of telemedicine, how medical professions apply technology to meet the needs of patients is limitless. Telemedicine has allowed for the identification and treatment of Hepatitis C in rural California in which decreased access to specialists decreases the likelihood of treatment.57 Telecommunications via satellite are used to allow physicians on ships or in remote locations to communicate and perform additional tests recommended by specialists videoconferencing from a different location.58 A 12-month study about telecommunication from an Antarctic station to Japan were for 26% and 35% of 140 total cases for internal medicine and orthopedic injuries, respectively.58 Recently, cell phones have been used to communicate images of skin lesions for dermatological consultation, Computed Tomography (CT) scans for

32 neurological consultation, and radiographs for diagnosis.59 The minimum technological requirements for include a cell phone camera with at least five megapixels and access to email to retrieve the radiograph.59 For the distribution of radiographs via cell phones, there was an 83.2% agreement between the definitive diagnosis and the diagnosis by five reviewers.59

There is a recent increase in remote monitoring systems for physicians to monitor the status of patients while in the comfort of their own home. Increasing patient adherence for taking medications at the appropriate times and monitoring vitals for the elderly are examples of the more simplistic applications of remote monitoring systems.60,61 Home health monitoring systems have varying capabilities depending on the chosen system including: hematocrit, respiration rate, pulse rate, blood pressure, oxygen saturation, ECG, and fetal heart rate.62-64 Of 83 human immunodeficiency virus patients,

85% reported better access to clinical data when using the telemedicine system for 1 year in comparison to 1 year using a standard care approach received at a hospital.65 Remote monitoring for implantable cardioverter defibrillators has allowed routine device management and early identification of complications in which clinicians can intervene with the appropriate measures.66

Classifications. The various types of telemedicine can be compared qualitatively based on the amount and quality of research, applicability, diagnostic accuracy, validity, outcome measures, and cost effectiveness.1 The mature fields of telemedicine include teleradiology and for the first tier.1 The second tier includes applications of telemedicine in need of more research to provide valid methods and optimal results, or maturing, such as and telecardiology.1 Under the third tier, all the other

33 applications of telemedicine are considered to be emerging and in need of further research to appreciate the appropriate application of technology.1

Equipment. The type and quality of the equipment used is essentially dependent on what is available to patients and what healthcare systems are willing to provide. Those using telemedicine consider the following aspects of a digital or video camera to provide a more realistic image for medical professionals: image quality, auto mode, auto focus, point and shoot, ease of use, and ease of camera operations.67 Therefore, the reliability of the diagnosis provided by telemedicine, whether the physician is viewing a photograph or video, or videoconferencing, is directly affected by the quality of the images and sounds produced by the equipment.3

Evaluation of use and effectiveness. Overall, telemedicine is evaluated by how well the healthcare system works and what outcomes are achieved by the system.56

Common expectations of telemedicine are: to improve of overall healthcare quality; to reduce travel expenses; to streamline process of care; and to increase access to medical care.1 Telemedicine assists in the avoidance of unnecessary transfers for 50% to 68% of cases.2 Patients have reported a 61% to 100% satisfaction rate when using telemedicine.2

Approximately 50% of 58 telemedicine users agreed that videoconferencing influenced routine work tasks by saving time, saving money, increasing in the knowledge of epidemiology, and increasing in networking.68

Challenges. Telemedicine has not been expanded to its fullest potential due to the underuse of the available capabilities of technology.1 However, there still remains a lack of national regulation of telemedicine across states and a lack of standard of care for clinicians to abide by.69 The Food and Drug Administration (FDA) is the most

34 appropriate regulatory agency because of its abilities to regulate the devices used in telemedicine practice.69 There is a lack of direct physical contact between the patient and physician during a telemedicine consultation, which causes a need to define the conditions which determine and/or establish the relationship between the two parties.69

Other associated challenges with telemedicine practice include liability for equipment failures or malfunctions, venues and jurisdiction, licensure requirements, and physician reimbursement.69 Insurers are more likely to compensate a physician for practicing telemedicine intrastate versus interstate, whereas other insurers exclude telemedicine compensation due to the lack of face-to-face interaction or the laying on of hands on the patient.69 Once national regulations of telemedicine, the establishment of patient-physician relationship conditions, and jurisdiction laws have been established, an increased use of telemedicine in everyday practice is expected.69

Summary

As running popularity continues to increase as a modality to maintain a healthy active lifestyle, the incidence of RRIs will also increase. Due to RRIs association with gait abnormalities, assessments are necessary. Gait assessments range from clinical observations to complex multicamera motion analysis systems used in research laboratories. These assessments often include physical examinations to identify the muscular imbalances and/or changes in flexibility affecting running gait.

The advances in technology have allowed clinicians to conduct clinical examinations of patients in different geographical locations, commonly referred to as telemedicine. The application of telemedicine for observational gait assessments would increase the accessibility of clinicians to runners. This would provide an online platform

35 in which runners could seek feedback from clinicians concerning gait abnormalities with the intention of decreasing the overall incidence of RRIs. Thus, the specific aims of this project are to:

 Develop a video gait screening tool, DISTLE, to identify gait abnormalities that

may predispose those who are physically active to injury.

 Establish evidence of validity for the developed video gait screening tool,

DISTLE, by comparing video observational gait analysis to a physical

examination.

36 Chapter 3: Methods

This study consists of multiple phases with the purpose to develop the DISTLE

(see Figure 2). The first phase focused on the review of literature to identify the gait abnormalities commonly observed by clinicians. Using the identified gait abnormalities, a survey was created for the second phase to determine the perceived clinical importance and parameters used for the observation of these gait abnormalities. The results of the second phase provided the clinically important gait abnormalities to create a video tool.

The tool used in the third phase evaluated the clinicians’ abilities to reliably identify a gait abnormality through a controlled video medium. The gait abnormalities reliably identified in the third phase were used to determine which abnormalities to include in the development of DISTLE. DISTLE was tested for validity in the final phase with clinicians serving as the participants. Each phase of this study that required human participants was individually approved by the Institutional Review Board of Ohio

University.

37

Phase I: Identification of Gait Abnormalities in Literaturea

Excluded gait Gait abnormalities abnormalities identified

Phase II: Clinical Relevanceb

Gait abnormalities Identified clinically not meeting meeting important gait inclusion criteria abnormalities

Phase III: Reliability of Identiciation of Gait Abnormalities Through Videoc

Clinically important Clinically important gait abnormalities not gait abnormalities meeting inclusion meeting inclusion criteria criteria

Phase IV: Validation of DISTLEd

Figure 2. Flowchart of the phases for this study. aPhase I consists of a literature review to identify all the possible gait abnormalities clinicians are taught to observe. bPhase II consists of a survey provided to clinicians to identify which of the abnormalities identified in Phase I are perceived as clinically important and how the abnormalities are viewed during an observational gait assessment. cPhase III evaluates the ability of clinicians to reliably identify gait abnormalities determined to be clinically important in Phase II with video. dPhase VI is to validate the use of video, demographics, and history questions in the creation of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) for the identification of gait abnormalities in a group of standardized patients by clinicians.

38 Phase I: Identification of Gait Abnormalities in Literature

Design and setting.

Purpose. To identify all of the gait abnormalities clinicians are instructed to observe in their patients through a literature review.

Methods. A literature research was performed using the electronic databases:

PubMed, Sportdiscus and ArticlesPlus. Key terms included ‘run*,’ ‘injury*,’ ‘gait,’

‘abnormal*,’ ‘deviation*,’ ‘assess*,’ and ‘analysis.’

Deliverables. Any gait abnormalities deemed unfeasible or having re petitive definitions using varied nomenclature were eliminated from inclusion in the second phase. A final list of identified gait abnormalities from the literature search was used to develop the Gait Abnormalities: Clinical Importance Survey (GACIS) (see Appendix A-

3).

Phase II: Clinical Relevance

Design and setting.

Purpose. To decrease the number of gait abnormalities identified through the literature review based on clinical importance and viewing parameters.

Participants. Currently licensed and practicing athletic trainers were recruited to serve as content experts (CEs) (see recruiting email in Appendix A-1). The athletic trainers were recruited based on association with Athletic Training Education Programs.

For tool development, a minimum of 5 to 10 CEs are typically needed.70

Instruments. GACIS provided the definitions for the 40 gait abnormalities found through the literature review in the first phase (see Appendix A-3). Each of the gait abnormalities were evaluated for clinical importance and how the clinician commonly

39 viewed the abnormalities. For the questions pertaining to clinical importance, CEs were asked to rate the clinical importance of each gait abnormality on a scale of 1 to 5 (least to most clinical importance). The CEs were then asked to identify the plane of view

(anterior, posterior, or lateral) most commonly used to observe for each of the gait abnormalities. Finally, the CEs were asked to identify the gait velocity (walking, jogging, or running) most commonly used to observe for each of the gait abnormalities. In total,

GACIS consisted of 120 questions, one third dedicated to each of the following sections: determining clinical importance, viewing parameters, and gait velocity of the patient.

Procedure. GACIS was administered to the CEs online through the Patient

Reported Outcomes Measurement Information System (PROMIS). CEs were required to digitally sign an to participate (see Appendix A-2). Prior to the completion of GACIS, definitions of each phase of the gait cycle were provided.

Participants had an unrestricted amount of time to complete GACIS. The answers were submitted, collected, and reviewed through PROMIS.

Data analysis. The dependent variables were evaluated independently of one another with SPSS. A mean of 3.5 or greater was used to determine the gait abnormalities with perceived clinical importance. A clinical importance score greater than or equal to

3.5 was used to identify the top 30% of clinically important gait abnormalities. A consensus of at least 75% among CE was used to determine the consistency of the plane of view and gait velocity observation parameters.

Deliverables. With the results from GACIS, specific gait abnormalities have been identified as clinically important in addition to the viewing parameters in which the majority of the clinicians are using to observe these gait abnormalities. The viewing

40 parameters and list of clinically important gait abnormalities were used to develop the

Reliability: Observational Gait Analysis Tool (ROGAT) for the third phase.

Phase III: Establishing Reliability for Video Medium

Design and setting.

Purpose. To establish the reliability of clinicians’ abilities to identify gait abnormalities with video.

Participants. Currently licensed and practicing athletic trainers were recruited

(see recruiting email in Appendix B-3). The athletic trainers were recruited based on affiliations with two accredited Athletic Training Education Programs.

Instruments. ROGAT was developed based on the clinically important gait abnormalities identified in the second phase of this study with GACIS. Healthy and physically active walkers (n = 9), with the possibility of gait abnormalities, volunteered to be filmed after the signing of a photo/video release document (see Appendix B-1). The volunteers’ gait were filmed in anterior, posterior, and lateral views. A physical examination of the lower extremity was administered following the filming of the gait for each walker. The physical examination included an oral history of injury to the lower extremity, observation of various deformities, range of motion, and special tests performed for the joints of the lower extremity (see the physical examination form,

Appendix B-2). A total of 25 videos of approximately 5 seconds in length and played on a loop were used for the development of ROGAT (see sample questions, Appendix B-6).

Procedure. ROGAT was administered to the participants through Qualtrics, an online survey software. Participants electronically consented to participate prior to the start of ROGAT (see consent form, Appendix B-4). A list of the definitions and

41 corresponding videos for the clinically important gait abnormalities were provided through an educational training session at the beginning of ROGAT (see Appendix B-5).

The participants were then asked to view and identify all of the gait abnormalities present within each of the 25 videos. Each plane of view, whether anterior, posterior, or lateral, was shown with the list of gait abnormalities according to the consensus agreement found in the second phase by GACIS.

Data analysis. SPSS was used to evaluate the measures of interrater and intrarater reliability via the kappa (κ) coefficient.71 The mean agreement between two participants and the mean agreement between time 1 and time 2 for the same participant were calculated to determine the central amount of agreement. Cohen’s kappa coefficient was then calculated to determine the interrater and intrarater reliability when factoring out the possibility of chance. The alpha level was set to p < 0.05.

The primary researcher completed a physical examination on two separate occasions for one volunteer walker to determine the intrarater reliability of the primary researcher. Cronbach’s alpha was calculated based on 19 physical examination measurements. The alpha level was set to p < 0.05.

Deliverables. This phase determined the reliability of clinicians to correctly identify gait abnormalities displayed in a recorded video. Gait abnormalities not reliably identified by a consensus of clinicians in ROGAT were removed in the development of

DISTLE. The compilation of results from the first through third phases were used to establish how and which of the gait abnormalities are to be observed in DISTLE.

42 Phase IV: Validating DISTLE

Design and setting.

Purpose. To validate the use of DISTLE for the identification of a patient’s gait abnormalities by a clinician through the use of video.

Participants. Licensed and currently practicing athletic trainers (n = 8) were recruited to serve as participants (see recruiting email, Appendix C-4). A total of 4 participants had less than 5 years and 4 had greater than 5 years of experience as practicing athletic trainers. The 2 participant subgroups were chosen to determine the feasibility of DISTLE application among clinicians with various levels of experience.

The literature has shown between 2 and 5 specialists are typically used to assess the reliability of evaluation techniques.45,59,72

Standardized patients. Physically active patients with and without gait abnormalities (n = 10) were identified and asked to serve as the standardized patients for the purpose of this phase. The ratio of normal gait patterns to abnormal gait patterns of the standardized patients were determined to represent the percent of runners with RRIs as observed in the literature. Due to the variance rate of 28 to 79 injuries per 100 runners reported in the literature, 8 of the 10 standardized patients have abnormal gait patterns compared to 2 with normal gait patterns.11

Instruments. DISTLE consists of a survey portion to obtain subjective information and a video portion for the recording of the standardized patient’s gait. The survey portion consists of questions to determine the following information about the patient: age, sex, history of injuries to the lower extremity, identification on a diagram of lower extremity pain while running, current level of physical activity, and mode(s) of

43 physical activity (see Appendix C-2). The video portion of DISTLE requires the patients to film themselves walking in an anterior, posterior, and lateral view from both the right and the left. DISTLE provides step- by-step instructions for the patient to follow to meet the required video parameters.

DISTLE video recording instructions. A solid background for the length of a

15ft walkway was used. Each of the four views were filmed twice in order for the best video to be presented in the standardized patient profile. The following guidelines were followed in the recording of gait for the video portion of DISTLE. These guidelines are an example of what the general population would receive as instructions to complete the video portion of DISTLE.

Standardized patient clothing. No shoes or socks were worn for the recording of the videos. The patients were instructed to wear running shorts or spandex that would allow exposure of the knees. The patients were asked to tuck in their t-shirt if it was not considered form fitting or extended more than a few inches past the Posterior Superior

Iliac Spine (PSIS).

Camera use. The camera of an iPad was used to record each of the standardized patient’s gait. The iPad camera is capable of 720p HD video recording.

Recording instructions for anterior and posterior view. The primary researcher sat on the floor at the edge of the 15ft walkway with the camera. The camera was held approximately at the height of the primary researcher’s shoulders. The camera was not moved throughout the recording of the standardized patient’s gait. The goal was to include the lower extremity throughout the majority of the anterior and posterior videos.

The patient was instructed to start at the furthest edge of the walkway facing the camera.

44 When instructed to begin walking, the standardized patient walked towards the camera and stopped approximately 1ft away from the camera. In contrast, the posterior view was filmed with the standardized patient starting at the closest edge of the walkway, 1ft away from the camera, and facing away from the camera.

Recording instructions for the lateral views. The primary researcher sat on a stool

10ft away from the walkway with the camera. The camera was held approximately at the height of the primary researcher’s shoulders. The camera was moved to follow the standardized patient throughout the entire walkway, keeping the patient as close to the center of the screen as possible. The goal was to include the lower extremity throughout the entire video extending from the mid trunk to the feet. The patient was instructed to start at one edge of the walkway with the left side facing the camera first. When instructed to begin walking, the standardized patient walked in front of the solid background along the walkway with the left side towards the camera. Similarly, the same procedures were followed to film the gait with a lateral view from the right.

Procedure.

Establish intrarater reliability of primary researcher. The intrarater reliability was established for the primary researcher who conducted all of the physical examinations for the standardized patients was established in the third phase.

Validity of standardized patients. The standardized patients were asked to sign a photo/video release form prior to any recording or gathering of information (see

Appendix C-1). The primary researcher distributed the survey portion of DISTLE to be completed by the standardized patient prior to the recording of the gait videos. Following the recording of the patient’s gait, the primary researcher conducted a lower extremity

45 physical examination. The physical examination is the same group of tests and quantitative measures used for the walkers in the development of ROGAT tested in the third phase (see Appendix C-3). The completed DISTLE file with each patient’s survey, video portions, and physical examination was given a numeric label to keep the identity of the patient anonymous.

Validation of DISTLE. Currently licensed and practicing athletic trainers were recruited to serve as the participants of the fourth phase. A screening survey was completed to ensure 4 participants with less than 5 years and 4 participants with greater than 5 years of experience as an athletic trainer were selected to participate (see

Appendix C-5). After consent to participate was given (see consent form, Appendix C-5), the participants completed an educational training session to become familiarized with the components of DISTLE and the gait abnormalities they are expected to identify along with their corresponding definitions and example videos (see educational training materials, Appendix C-7). The participants then assessed the DISTLE patient profiles of the 10 standardized patients (see sample questions, Appendix C-8). Participants were administered 1 of 2 versions of the DISTLE patient profiles: one version included just the video portion; the other version included both the survey and video portions of DISTLE.

Randomly 2 of the 4 participants for each participant subgroup were selected to receive the completed DISTLE patient profiles and the other 2 were selected to receive only the video portion of DISTLE.

Data Analysis. SPSS were used to evaluate the measures of interrater and intrarater reliability via the kappa (κ) coefficient.71 The kappa coefficient was calculated for the agreement between the clinicians who received the complete DISTLE data and

46 those who only received the video portion of DISTLE. The kappa coefficient was also calculated for the agreement between the same clinician on evaluating the same performance twice. The alpha level was set to p < 0.05.

Deliverables. A completed instrumentation and validation of DISTLE to serve as a plausible technological system providing access to gait assessment capabilities for runners across the country.

47 Chapter 4: Results

This chapter presents the findings for each of the four phases of this study. The results of the first phase generated the list of gait abnormalities identified in the literature.

An analysis of which gait abnormalities were perceived as clinically important and how the content experts prefer to view each of the abnormalities is presented for the second phase. Reliability for the identification of clinically important gait abnormalities through video was assessed during the third phase. The fourth phase assessed the validity of the established gait abnormalities for use in DISTLE in comparison to the lower extremity physical examination.

Phase I: Identification of Gait Abnormalities

A total of 60 gait abnormalities were identified in the literature. The abnormalities ranged in anatomic location from the toes to the trunk. Of the 60 gait abnormalities, 20 were eliminated primarily due to the varied nomenclature with similar denotations.

Steppage, for example, is the combination of exaggerated or excessive knee and hip flexion.39 Steppage was not included for it is a combination of 2 gait abnormalities that can occur individually. Other exclusion criteria included the lack of feasibility of a clinician observing for and identifying the gait abnormality during an observational gait assessment, ie, range of motion of the toes throughout the gait cycle.

Deliverables. The remaining 40 abnormalities were continued on to the second phase in order to determine clinical relevance (see Table 3).

48

Table 3. Forty Gait Abnormalities Identified in the Phase I

Foot and Ankle Knee Hip Posture

Base of support XS knee extension Circumduction Anterior trunk bending width

XS dorsiflexion XS knee flexion XS abduction Increased lumbar lordosis

XS lateral contact Extensor thrust XS adduction Lateral trunk bending

XS medial contact INAD knee extension XS hip flexion Posterior trunk bending

XS plantarflexion INAD knee flexion XS external rotation

XS supination Knee hyperextension XS internal rotation

XS toe-in Swing leg across Hip hiking midline

XS toe-out Wobble INAD hip extension

Flat-foot contact INAD hip flexion

Foot slap

Hindfoot supination

Hyperpronation

Lateral heel whip

Medial heel whip

No heel off

Premature heel rise

Step length problems

Toe drag

Vaulting Abbreviations: INAD, inadequate; XS, excessive.

49 Phase II: Clinical Relevance

Participants. A total of 24 licensed and currently practicing athletic trainers

(mean ± SD: age = 27 ± 10.5 yrs; years of experience = 5.5 ± 10.5 yrs; 11 male, 13 female) volunteered to serve as CEs.

Data Analysis. The dependent variables were evaluated independently of one another with SPSS. A mean of 3.5 or greater (on a scale of 1 to 5; least to most clinical importance) was used as the threshold for clinically important for each gait abnormality.

A clinical importance score greater than or equal to 3.5 was chosen because it represented the top 30% of clinically important gait abnormalities. Of the 40 gait abnormalities, 22

(55%) were considered to be clinically important (see Table 4).

An agreement of at least 75% of the CEs was used to determine the plane of view and gait velocity observation parameters. CEs varied in their opinions of which plane of view should be observed for 18 of the 22 (81.8%) clinically important abnormalities, agreeing on only 4 of the 22 abnormalities (18.2%). CEs agreed that 6 of the 22 (27%) abnormalities should be observed while the patient is walking; opinions varied for the type of velocity that should be used to observe the remaining 16 of the 22 (73%) abnormalities. The results of the viewing parameter agreement of the clinically important gait abnormalities are presented in Table 5.

Deliverables. The 22 clinically important gait abnormalities were continued on to the third phase to test the reliability of clinicians’ abilities to correctly identify these gait abnormalities through videos.

Table 4. Phase II: Clinical Importance Mean for Gait Abnormalities 50

< 2.99 (Mean) 3.00 – 3.49 (Mean) > 3.50 (Mean)

Extensor thrust (2.87) Premature heel rise (3.08) XS hip flexion (3.5)

Base of support width (2.88) Medial heel whip (3.12) INAD hip flexion (3.52)

XS dorsiflexion (3.16) Knee hyperextension (3.52)

XS external rotation (3.18) Hyperpronation (3.52)

Lateral heel whip (3.24) Flat-foot contact (3.52)

XS plantarflexion (3.28) XS toe-in (3.52)

Posterior trunk bending (3.32) INAD hip extension (3.55)

XS toe-out (3.32) Hindfoot supination (3.56)

XS adduction (3.35) Vaulting (3.6)

Anterior trunk bending (3.36) Wobble (3.61)

XS knee flexion (3.39) INAD knee flexion (3.65)

XS internal rotation (3.41) Lateral trunk bending (3.68)

Swing leg across ML (3.43) Toe drag (3.68)

Step length problems (3.44) XS abduction (3.7)

INC lumbar lordosis (3.45) XS knee extension (3.74)

INAD knee extension (3.48) XS supination (3.79)

Foot slap (3.84)

Hip hiking (3.86)

No heel off (3.88)

XS lateral contact (3.88)

Circumduction (3.91)

XS medial contact (4.08) Abbreviations: INAD, inadequate; XS, excessive; INC, increased; ML, midline. Mean was calculated based on a 5-point Likert scale.

51 Table 5. Phase II: Viewing Parameters for Clinically Important Gait Abnormalities

> 75% agreement 50% - 75% agreement Gait Abnormality View Velocity View Velocity

XS lateral contact P W

XS medial contact P W

XS supination W A/P

XS toe-in W A

Flat-foot contact L

Foot slap W

Hindfoot supination P W

Hyperpronation W P

No heel off P W

Toe drag L W

Vaulting W

XS knee extension L W

INAD knee flexion L W

Knee hyperextension L W

Wobble A W

Hip circumduction A/P W

XS hip abduction W

XS hip flexion L W

Hip hiking W P

INAD hip extension L W

INAD hip flexion L W

L trunk bending W P Abbreviations: INAD, inadequate; XS, excessive; A, anterior; P, posterior; L, lateral.

52

Phase III: Establishing Reliability for Video Medium

Participants. A total of 16 licensed and currently practicing athletic trainers

(mean ± SD: age = 27.9 ± 8.8 yrs; 7 male, 9 female; experience as practicing athletic trainer 4.9 ± 6.5 yrs; 13 without extra gait training, 3 with extra gait training) volunteered to participate in the study. Of the 16 original participants, 8 participants agreed to complete ROGAT a second time (mean ± SD: age = 23.6 ± 2.0 yrs; 3 male, 5 female; experience as practicing athletic trainer 2.0 ± 1.9 yrs; 7 without supplemental gait training, 1 with supplemental gait training). The frequency of gait assessments conducted clinically varied for the participants (see Table 6).

Table 6. Phase III: Frequency of Gait Assessments by Participants

> 5 Yrs of < 5 Yrs of Frequency Total Experience Experience

Time 1 Time 2 Time 1 Time 2 Time 1 Time 2

Never 3 2 1 * 2 2

< Once a month 7 3 1 * 6 3

Once a month 1 * 1 * * *

2-3 times a 3 2 1 1 2 1 month

Once a week 2 1 1 * 1 1

2-3 times a week * * * * * *

Daily * * * * * * * Indicates no answers obtained for option.

53

Intrarater reliability of primary researcher. The agreement between time 1 and time 2 of the primary researcher’s lower extremity physical examination measurements for 1 volunteer walker from the third phase was assessed. There were a total of 19 measurements included in the assessment. A Cronbach’s alpha of 0.974 was determined with a p < 0.05.

Interrater reliability. The agreement among multiple raters was assessed by considering the number of agreements for the presence and absence of gait abnormalities out of the total number of questioned variables. The mean agreement between raters was

0.80 ± 0.07. However, the range of agreement among any pair of raters for ROGAT is

0.63 to 0.98. Table 7 displays the agreement among all raters with greater than 5 years of experience and the agreement among all raters with less than 5 years of experience assessed separately. A reliability measure falling between 0.5-0.75 is considered to have moderate clinical usefulness, therefore a reliability measure greater than 0.75 is desirable to have good clinical usefulness as a tool.17

Both the minimum and maximum Cohen’s kappa calculated for interrater reliability equaled zero. A Cohen’s kappa value of less than 0.7 is considered not satisfactory.

Intrarater reliability. The agreement among the same rater for time 1 and time

2 was assessed by considering the number of agreements on the presence or absence of an abnormality out of the total number of possible agreements. The average amount of agreement for the same rater on 2 separate occasions was 0.79 ± 0.4. The range of agreement among the same rater for time 1 and time 2 is 0.74 to 0.84. There were not

54 enough participants with greater than 5 years of experience who participated in the second administration of ROGAT; therefore, a comparison between intrarater reliability based on experience was not made.

The value ranges for Cohen’s kappa was 0.08 to 0.13 for intrarater reliability. A

Cohen’s kappa value of less than 0.7 is considered not satisfactory.

Table 7. Phase III: Reliability of Identifying Gait Abnormalities

> 5 Yrs of < 5 Yrs of Overall Experience Experience

Interrater 0.80 ± 0.07 0.79 ± 0.07 0.80 ± 0.07

Intrarater 0.79 ± 0.04 * * Mean reliability ± standard deviation. * Indicates inadequate number of second time participants with > 5 yrs of experience to compare subgroups.

Validity. To determine validity, a mean of the participants’ determination of present gait abnormality (1) or absence of gait abnormality (0) for each video was compared to the findings of the physical examination. The rate of agreement between all the raters who correctly identified the presence or absence of a gait abnormality and the total number of participants was determined for each gait abnormality asked to be identified by the participant in each video. The mean for the rate of agreement for each abnormality was calculated. A mean of > 0.15 or < 0.8 was used to determine which gait abnormalities were correctly identified as being present or absent by the participant in comparison to the PE findings.

55 The criteria used to determine which gait abnormalities had an agreement among the raters and the PE included both a mean of > 0.8 and SD < 0.2. Of the 22 (54.5%) clinically important gait abnormalities, 12 met the initial validity criteria (see Table 8).

Additional abnormalities were considered if the mean was > 0.8 and the mean interrater reliability was > 0.8 or < 0.15. Due to this secondary criterion, 4 additional abnormalities were added to the original 12 valid gait abnormalities (see Table 8).

The level of experience of the participant as a practicing athletic trainer was considered with respect to the validity results. Although the average for both the less than

5 years and greater than 5 years of experience have the a mean agreement with the PE, or validity, within 1% of each other (> 5yrs: 0.78 ± 0.15; < 5yrs: 0.77 ± 0.15) the abnormalities meeting the primary and secondary inclusion criteria listed above differ

(see Table 9-A and Table 9-B).

56

Table 8. Phase III: Validity of Abnormality Identification and Physical Exam

Gait Abnormality Mean SD Validity Criteria

XS hip flexion 1.0 0.04 a

Toe drag 0.9 0.28 b

Hip hiking 0.9 0.24 b

XS medial contact 0.9 0.10 a

XS knee extension 0.9 0.10 a

XS supination 0.9 0.10 a

Toe-in 0.9 0.10 a

Hindfoot supination 0.9 0.09 a

No heel off 0.9 0.06 a

Vaulting 0.8 0.32 b

Lateral heel whip 0.8 0.30 b

Wobble 0.8 0.20 a

XS hip abduction 0.8 0.16 a

Flat-foot contact 0.8 0.14 a

INAD hip flexion 0.8 0.12 a

INAD knee flexion 0.8 0.08 a Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.8 or < 0.15. c Indicates gait abnormalities not meeting either validity criteria.

Table 8. Phase III: Validity of Abnormality Identification and Physical Exam 57 (Continued)

Gait Abnormality Mean SD Validity Criteria

Knee hyperextension 0.7 0.44 c

XS lateral contact 0.7 0.36 c

Hip circumduction 0.7 0.35 c

Foot slap 0.7 0.33 c

Hyperpronation 0.7 0.23 c

Lateral trunk bending 0.6 0.43 c

INAD hip extension 0.6 0.33 c

Medial heel whip 0.3 0.39 c Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.8 or < 0.15. c Indicates gait abnormalities not meeting either validity criteria.

58 Table 9-A. Phase III: Validity Results for > 5 Years of Experience

Gait Abnormality Mean SD Validity Criteria

XS hip flexion 0.98 0.06 a

Hindfoot supination 0.96 0.08 a

XS supination 0.92 0.18 a

XS knee extension 0.90 0.14 a

Toe drag 0.90 0.25 b

No heel off 0.89 0.12 a

Lateral heel whip 0.86 0.31 b *

XS hip abduction 0.85 0.18 a

XS medial contact 0.84 0.16 a

Toe-in 0.84 0.26 b

Hip hiking 0.82 0.26 b

INAD hip flexion 0.82 0.15 a *

INAD knee flexion 0.80 0.19 a *

Flat-foot contact 0.80 0.13 a * Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.8 or < 0.15. * Indicates different gait abnormality compared to < 5 yrs of experience.

59 Table 9-B. Phase III: Validity Results for < 5 Years of Experience

Gait Abnormality Mean SD Validity Criteria

XS hip flexion 0.98 0.04 a

No heel off 0.93 0.07 a

XS supination 0.93 0.08 a

XS knee extension 0.90 0.10 a

Toe-in 0.89 0.08 a

Hindfoot supination 0.88 0.12 a

XS medial contact 0.87 0.10 a

Hip hiking 0.86 0.25 b

Toe drag 0.83 0.30 b

Vaulting 0.83 0.31 b * Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.8 or < 0.15. * Indicates different gait abnormality compared to > 5 yrs of experience.

Deliverables. Only the 16 gait abnormalities (see Table 6) that met the initial and secondary validity criteria were carried on to the fourth phase to be included in the final

DISTLE product to be tested for clinical application.

Phase IV: Validating DISTLE

Participants. A total of 7 licensed and currently practicing athletic trainers (mean

± SD: age = 28.8 ± 8.9 yrs; 4 male, 3 female; experience as practicing athletic trainer 7.0

60 ± 8.4 yrs; 6 without supplemental gait training, 1 with supplemental gait training) volunteered to participate in the study. The demographics of the participants are further broken down by subgroups according to years of experience and the version of the

DISTLE assessment system (see Table 10).

Table 10-A. Phase IV: Participant Demographics by Years of Experience

> 5 Years < 5 Years

Highest Education Bachelor of Science 0 4 Master of Science 2 0 Doctor of 1 0 Philosophy

Practice Setting High School 2 3 Other 1 1

Frequency of Gait < Once a month 3 3 Assessment 2-3 times a month 0 1

Table 10-B. Phase IV: Participant Demographics by DISTLE Version

Full Version No Survey Portion

Highest Education Bachelor of Science 2 2 Master of Science 1 1 Doctor of 1 0 Philosophy

Practice Setting High School 2 3 Other 2 0

Frequency of Gait < Once a month 3 3 Assessment 2-3 times a month 1 0

61 Interrater reliability. The agreement among multiple raters was assessed by considering the number of agreements for the presence and absence of gait abnormalities out of the total number of questioned variables. The mean agreement between raters was

0.78 ± 0.03. However, the range of agreement among any pair of raters for the DISTLE assessment system was 0.72 to 0.85. The agreement among the raters was further assessed based on the version of the DISTLE assessment system received and years of experience (see Table 11).

The interrater reliability for identifying the presence or absence of the individual gait abnormalities was also assessed. Of the 16 (56%) gait abnormalities assessed in the

DISTLE assessment system, 9 abnormalities resulted in a reliability measure that indicates good clinical usefulness (> 0.75)17 (see Table 12).

Table 11. Phase IV: Interrater Reliability Based on Subgroups

Mean Agreement Standard Deviation

Years of Experience > 5 years 0.83 ± 0.03 < 5 years 0.75 ± 0.03

DISTLE Version Full version 0.81 ± 0.02 No survey portion 0.75 ± 0.01

62

Table 12. Phase IV: Interrater Reliability for Gait Abnormalities

Gait Abnormality Mean Agreement Clinical Use

No heel-off 0.97 a

XS hip flexion 0.95 a

XS hip abduction 0.92 a

Wobble 0.89 a

XS knee extension 0.88 a

XS toe-in 0.86 a

Vaulting 0.80 a

XS supination 0.80 a

Hip hiking 0.79 a

Toe-drag 0.74 b

INAD knee flexion 0.72 b

INAD hip flexion 0.69 b

Lateral heel whip 0.68 b

XS medial contact 0.66 b

Hindfoot supination 0.64 b

Flat-foot contact 0.63 b Abbreviations. INAD, inadequate; XS, excessive. a Indicates good clinical usefulness (> 0.75). b Indicates moderate clinical usefulness (0.5-0.75).

Validity. Validity was determined by identifying the percentage of the participants correctly identifying the presence or absence of the gait abnormalities in each

63 video in comparison to the physical examination. The results were then stratified to determine the mean rate of agreement between the participants’ correct answer and the physical examination for each gait abnormality assessed within DISTLE.

The initial criteria used to determine which gait abnormalities had an agreement among the raters and the PE included both a mean of > 0.8 and SD < 0.2. Of the 16 gait abnormalities assessed within DISTLE, 6 abnormalities (37.5%) met the initial validity criteria (see Table 13). Additional abnormalities were considered if the mean agreement between the participants and the PE was > 0.8 and the mean interrater reliability for the abnormality was > 0.75. Due to this secondary criterion, 2 additional abnormalities were added to the original 6 valid gait abnormalities (see Table 13).

Table 13. Phase IV: Validity of Abnormality Identification and Physical Exam

Gait Abnormality Mean SD Validity Criteria

No heel off 0.99 0.05 a

XS hip flexion 0.97 0.07 a

XS knee extension 0.94 0.10 a

Wobble 0.91 0.18 a

XS hip abduction 0.89 0.27 b

XS toe-in 0.89 0.21 b

Vaulting 0.88 0.16 a

INAD knee flexion 0.81 0.18 a Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.75.

64

To identify if the use of the survey portion to obtain supplemental history information is necessary for the implementation of DISTLE, the validity of identifying the gait abnormalities was further assessed by comparing the results of the group that received the full version of DISTLE and the group who did not receive the survey portion of DISTLE. The group receiving the full version of DISTLE met the initial validity criteria for 6 of 16 (37.5%) abnormalities and 2 of 16 (12.5%) abnormalities met the secondary criteria (see Table 14). The group receiving the version of DISTLE without the survey portion met the initial validity criteria for 3 of 16 (18.75%) abnormalities and 4 of

16 (25%) abnormalities met the secondary criteria (see Table 15).

Table 14. Phase IV: Validity Results for Group Receiving Full Version of DISTLE

Gait Abnormality Mean SD Validity Criteria

XS hip flexion 1.0 0.00 a

INAD knee flexion 0.81 0.20 a *

No heel off 1.00 0.00 a

Vaulting 0.94 0.16 a

Wobble 0.93 0.20 a

XS hip abduction 0.86 0.32 b

XS knee extension 1.00 0.00 a

XS toe-in 0.88 0.21 b Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.75. * Indicates different gait abnormality compared to no survey version of DISTLE group.

65

Table 15. Phase IV: Validity Results for No Survey Version of DISTLE Group

Gait Abnormality Mean SD Validity Criteria

No heel off 0.97 0.11 a

XS hip flexion 0.93 0.17 a

XS hip abduction 0.92 0.24 b

Wobble 0.90 0.19 a

XS toe-in 0.90 0.22 b

XS knee extension 0.85 0.23 b

Vaulting 0.80 0.23 b Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.75.

To determine if the level of experience as a practicing clinician changed the validity of identifying the gait abnormalities, results among the subgroups of those with less than 5 years and those with greater than 5 years of experience were compared. For the group of participants with greater than 5 years of experience, 6 of 16 (37.5%) abnormalities met the initial validity criteria and 2 of 16 (12.5%) abnormalities met the secondary validity criteria (see Table 16). For the group of participants with less than 5 years of experience, 3 of 16 (18.75%) abnormalities met the initial validity criteria and 4 of 16 (25%) abnormalities met the secondary validity criteria (see Table 17).

66

Table 16. Phase IV: Validity Results with Greater Than 5 Years of Experience

Gait Abnormality Mean SD Validity Criteria

XS hip flexion 0.98 0.07 a

Vaulting 0.98 0.07 a

XS knee extension 0.98 0.07 a

Wobble 0.92 0.18 a

Hindfoot supination 0.90 0.16 a *

XS hip abduction 0.87 0.31 b

XS toe-in 0.87 0.28 b

INAD hip flexion 0.82 0.20 a * Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.75. * Indicates different gait abnormality compared to < 5 years of experience.

67 Table 17. Phase IV: Validity Results with Less Than 5 Years of Experience

Gait Abnormality Mean SD Validity Criteria

No heel off 0.97 0.11 a

XS hip flexion 0.93 0.17 a

XS hip abduction 0.92 0.24 b

Wobble 0.90 0.19 a

XS toe-in 0.90 0.22 b

XS knee extension 0.85 0.23 b

Vaulting 0.80 0.23 b Abbreviations: INAD, inadequate; XS, excessive; SD, standard deviation. a Indicates gait abnormalities meeting initial criteria of mean > 0.8 and SD < 0.2. b Indicates gait abnormalities meeting secondary criteria of mean > 0.8 and interrater reliability > 0.75.

Deliverables. The clinical application of the DISTLE assessment system during the fourth phase identified only the 8 of the 16 (50%) gait abnormalities (see Table 12) meeting the initial and secondary validity criteria. Years of experience and the inclusion or exclusion of the survey portion of DISTLE influenced which gait abnormalities met the initial and secondary validity criteria.

68 Chapter 5: Discussion

The cumulative results of this multiple-phase study have brought forth many questions and considerations with respect to the implementation of a telemedicine approach to conducting gait assessments. The results of the first, second, and third phases question the need for the standardization of gait assessments for a physically active population. The third and fourth phases briefly touch on the capabilities and uses of technology for the application of a telemedicine approach for gait assessments. It is unclear if the experience level of the participants, with respect to athletic training and/or gait assessments, affected the results of each phase, which then determined variables of the subsequent phases.

Lack of Gait Assessment Standardization

Total assessment. The results of the literature review in phase I identified a lack of universal terms and definitions used for gait assessments. In addition, there is a lack of evidence supporting how to best view each of the gait abnormalities with respect to plane of view and velocity, though the material is briefly mentioned in textbooks. This is of great concern for those conducting video observational gait assessments in which the clinician cannot shift positions to change the angle of view for observing an abnormality due to the video being previously recorded.

There is also limited research on the presence of a carry-over effect of gait abnormalities for various velocities, ie, walking to jogging. The results of the second phase concluded most clinicians preferred to view the gait abnormalities while the patient was walking instead of at a faster velocity. One study found rearfoot pronation occurring during both walking and running gait; however, the amount of rearfoot pronation

69 occurring during walking was significantly greater.73 The results of this study suggested any gait assessment should be based on the velocity in which the individual normally competes or trains.73

Structure of assessment. ROGAT and DISTLE both provided a list of the gait abnormalities participating clinicians were expected to observe for during the video gait assessments. Previous studies have provided structured lists of the gait abnormalities during video observational gait assessments for the participating clinicians regardless of level of expertise.45,46,74 Similar to these studies, the list of gait abnormalities to assess for within ROGAT and DISTLE provided structure and guidance for the participants observing gait abnormalities. However, athletic trainers do not commonly use a check-off list of which gait abnormalities to observe for during an assessment. Providing the lists within ROGAT and DISTLE did not replicate a clinical application of gait assessment used by clinicians. The results of a study comparing recall and prompted gait assessments with structured lists would better determine the influence and need for structured gait assessments.

Other components of gait assessments that were excluded from the ROGAT and

DISTLE assessment systems include the grading of the severity of the gait abnormality and identifying what part of the gait cycle the abnormality was present.45,46,74 Reliability studies commonly use 3- and 4-point Likert scales to grade the severity of the abnormality, with the two extremes meaning the gait abnormality is absent or severe.45,46

It is important to note that these studies asked participants to identify 10 or fewer gait abnormalities and how the abnormality presented with respect to occurrence during the gait cycle and severity.45,46,74

70 Target population. The majority of the literature focuses on the evaluation of observational gait assessment tools and the reliability of identifying gait abnormalities in special populations.28,45,46,74 Structured gait assessments specifically designed for the physically active population are lacking, leaving clinicians to conduct gait assessments without a reference guide.

There is a lack of evidence supporting the prevalence of specific gait abnormalities for the physically active population. Certain abnormalities found in phase

III that did not meet the initial and secondary validity criteria are more likely to be found within the physically active population, ie, hip circumduction, hyperpronation, lateral trunk bending, and medial heel whip. This may be attributed to the overwhelming number of possible gait abnormalities the participant was asked to view in a video.

Physical examination findings with associated gait abnormalities. The physical examination and the gait of the volunteer walker or standardized patient of phase

III and phase IV, respectively, were considered together by the primary researcher to determine the presence or absence of a gait abnormality. There is currently little research directly correlating physical examination findings, singly or in combination, with certain gait abnormalities. The lack of evidence required the primary researcher to form the best decision based on her understanding of anatomical relationships and experiences as a clinician. Therefore, the right answer provided by the primary researcher on which

ROGAT was validated cannot be considered the gold standard.

Use of educational tool. An educational training session was required of participants prior to viewing videos for gait abnormalities in both the third and fourth phases. The main purpose of the educational tool was to familiarize participants with the

71 tool and the clinically important gait abnormalities with corresponding definitions and example videos. In contrast, a similar study evaluating the effectiveness of the Functional

Gait Assessment (FGA) did not did not allow for prior education or an extensive informative session prior to asking participants to apply the tool during a gait assessment.74 This decision was made to determine if prior instruction was necessary for clinicians to understand how to use a tool, not to ensure they understood the definitions of the gait abnormalities.74 Due to all participants receiving the educational training session, it is unclear if the influences of an extensive educational training session on the gait abnormalities is necessary for clinicians prior to the use of DISTLE.

Telemedicine: Store and Forward Approach

Previous studies have found slight to moderate reliability for the identification of gait abnormalities with the use of video.28,45 When the probability of chance is factored out the good reliability determined in the third phase dropped to poor reliability. It is important to consider the various video filming and viewing factors that may influence reliability.

Considerations of recorded video. The store and forward approach limits clinicians who are reviewing the gait abnormality because the video cannot be adapted to accommodate the need to view a particular segment of the lower extremity differently. A majority of the videos included a limited number of steps, often with the first step missing from the video in the posterior view. This limits clinicians who are reviewing the video from forming a clinical decision based on however many steps are provided.

In the fourth phase, 4 total passes of the standardized patient walking at a comfortable pace occurred. Clinicians were asked to identify gait abnormalities in the

72 anterior, posterior, lateral from the right, and lateral from the left views for a length of

15ft. A previous study instructed patient walkers to complete a total of 6 passes at a normal walking pace for a length of 30ft, 2 passes occurred for each of the lateral views.28 There is a lack of standardization across the literature with respect to the desired length of walkway a patient should be instructed to walk in a video and how far away the individual recording the video should be in relation to the walker.28,45,46

Speed of video viewing. Participating clinicians were not provided the option of slowing down the video to view the gait of an individual at a slower pace. This was determined based on technical capabilities of the software being used to distribute

ROGAT and DISTLE and could be considered as the closest replication of a clinical observational gait assessment. Two studies have used the slow- and stop-action techniques to emphasize the swing and stance phases in an attempt to improve the reliability of the video observational gait assessment.28,45 The reliability of identifying gait abnormalities in a video assessment with the use of the slow- and stop-action techniques is reported to be slight to moderate.28,45 The combined results of this study and the literature suggests that it may not be the speed of the video that influences clinicians’ abilities to identify gait abnormalities. Other options such as angle of camera view, level of the camera, and simultaneous viewing of various camera angles should be further investigated to determine the best recording parameter recommendations.

Plausible method to increase accessibility. Poor reliability was determined for identifying the gait abnormalities through video when the chance of probability is factored out. A large amount of agreement between the participants occurred when identifying the absence of a gait abnormality from the video. This difference from good

73 to poor reliability in the third phase with the chance of probability factored out suggests the lack of gait abnormalities and a high specificity.

It is important to note the practicality of DISTLE as a telemedicine approach.

The majority of Americans with cellular devices are equipped with smartphones or phones with quality video recording capabilities. The filming of the gait videos during the third and fourth phases took no longer than 5 minutes of the primary researcher’s time to complete. In the practical application of the proposed DISTLE product, one would expect a potential patient to take the same amount of time to complete the video portion of

DISTLE. This requires a small amount time commitment by the potential patient in which can be completed whenever convenient for them. However, further research is needed in order for a reliable and valid tool to provide the best recorded views for the gait abnormalities to be identified.

Experience of Clinician

There was no difference observed in the overall agreement when compared to the physical examination between those with greater than 5 years of experience and those with less than 5 years of experience as an athletic trainer. It is often thought that diagnostic accuracy increases with increased experience. The results of this study in the third phase, testing the reliability of a clinician in the identification of a gait abnormality, did not support this ideology.

There is limited research on the effects of a clinician’s experience level on diagnostic accuracy for various types of pathologies. There have been findings of greater inter- and intrarater reliability among the more experienced readers with ECG interpretation.75 In addition, more experienced readers relied less on the subjective

74 information and in comparison to less experienced readers who based their clinical decisions on subjective information.75 These findings of how more experience influences the interpretation of a test do not agree with the results from the third phase.

However, another study reported no significant differences in experience level for the accurate diagnosis of mental health issues.76

Limitations

Participant population. The majority of the participants for the second and third phases consisted of graduate students who had less than 5 years of experience due to accessibility. The participants of these two phases lacked a wide range of years of experience in which the foundation of the DISTLE components were determined. This may have influenced which gait abnormalities resulted in the final DISTLE product. The results of the second phase in which the clinical importance and viewing parameters for the gait abnormalities were determined may have been different if GACIS had been distributed to a more experienced population with respect to years of athletic training experience and clinical application of gait assessment. The same consideration should be made for the results of the third phase in which the reliability of identifying gait abnormalities through video was determined. It is important to note the majority of the participants of the third phase reported conducting gait assessments clinically less than once a month; only 12.5% of the participants reported conducting gait assessments clinically once a week.

Recorded videos. The volunteer walkers and standardized patients used in the third and fourth phases, respectively, were a convenience sample of physically active individuals with gait abnormalities at the university. Not all of the clinically important

75 gait abnormalities were represented in multiple videos during the third phase for the reliability assessment. Ideally, the reliability of each gait abnormality should have been assessed on multiple occasions within ROGAT for multiple volunteer walkers.

The available space for the recording of the gait videos was limited and therefore limited the length of the desired walkway for all four views. This study used a walkway length of 15ft, half the length of the 30ft walkways used in a similar study.28 Though the videos were displayed to the participating clinicians on a loop, this limitation required the clinician to review each gait video more than once on the loop. The short distance of the walkway may not allow the individual to fall into a normal stride affecting the presence of any naturally occurring gait abnormalities.

Physical examination. The lower extremity physical examination was conducted solely by the primary researcher in a clinical laboratory setting. Manual muscle testing was not included in the either of the physical examinations for the volunteer walkers of phase III or the standardized patients of phase IV due to health status of individual and feasibility. Commonly performed orthopedic tests were excluded from the physical exam if the positive test was based on subjective information provided by the patient, such as pain. Unlike scalar measurements such as goniometry, reporting the severity of pain is relative to the individual experiencing the discomfort.

Significance

There are two significant clinical implications resulting from this multiple phase study. First, certain clinically important gait abnormalities have been identified as being reliably assessed by clinicians in a recorded video after a brief educational training session. Secondly, the combined results have made apparent that there is still a need for

76 the standardization of gait assessments for clinical use prior to the application of a telemedicine approach. The lack of consensus among clinicians concerning the clinical importance and viewing parameters of gait abnormalities observed in a physically active population proved to create an issue when they were asked to reliably identify the same gait abnormalities through video.

The standardization of observational gait assessments and recording variables for video observational gait assessments is necessary prior to the application of a valid encompassing tool utilizing a store-and-forward approach, ie, DISTLE.

Future Research

Further research is needed before DISTLE or any video gait assessment system can confidently substitute the need for a clinician to be in the same geographical location to conduct a physical examination on a patient. The perceived clinical importance and reliability of identifying gait abnormalities during a video observational gait assessment should be further assessed with a larger population of athletic trainers. These athletic trainers should have experience with gait assessments to determine whether extensive gait training or the clinical application of regular gait assessments is necessary.

Additional research is still needed for the associations and implications of gait abnormalities with other abnormalities and/or physical examination findings in order for a plausible technological medium to be used as a substitution for physical interaction between clinician and patient.

Addressing the inconsistencies of video gait assessments could improve reliability. Standardizing the length of the walkway is necessary to provide an adequate number of steps in the video and allow participants to walk naturally. The distance of the

77 camera from the walkway, the level of the camera, the use of multiple viewing angles outside of the anatomical planes, and the use of stop or slow down functions need to be determined to provide viewing clinicians with the best possible video to observe for gait abnormalities.

Conclusion

Assessing the reliability of clinicians’ abilities to assess the presence or absence of gait abnormalities through a previously recorded video has been identified as an issue that needs to be addressed. A method to increase clinicians’ abilities to reliably identify all clinically important gait abnormalities through a previously recorded video needs to be developed and tested. This method ideally would address standardizing video observational gait assessments by identifying the length in which an individual needs to walk, the use of a stop or slow down function for video viewing, the need for multiple views besides the anatomical planes, and/or if a more thorough educational training session on gait abnormalities is necessary. It is crucial that the reliability of identifying each clinically important gait abnormality is increased to no less than moderate. The gait abnormalities that were not reliably identified in third phase of this study did not continue on to the final phase. This exclusion of abnormalities limited the available options for participating clinicians to identify the gait abnormalities of the standardized patients, thereby potentially omitting the identification of a gait abnormality that could explain the pain experienced by the standardized patient during physical activity.

Ideally, no clinically important gait abnormality should have less than a moderate reliability nor should any abnormality be omitted from the finalized version of DISTLE for clinical use. It is imperative for the final version of DISTLE to include all gait

78 abnormalities possible within the running population. If gait abnormalities are omitted, clinicians using DISTLE will not be able to form an inclusive and encompassing decision of the gait abnormalities present during an assessment. In order to best address the needs of the running population, a fully comprehensive system must provide the highest quality of video gait assessments without the need for a clinician to be in the same geographical location as the patient.

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89 Appendix A-1: GACIS Recruiting Email

Dear Practicing Athletic Trainer:

I am writing to request your assistance with my research. There has been an association made between different gait abnormalities and specific injuries in runners. As part of my research, I will be evaluating the clinical importance of observed gait abnormalities according to clinicians and the associated parameters of a gait analysis that is preferred by clinicians.

Please take approximately 15 minutes out of your busy schedule to complete the Gait Abnormalities: Clinical Importance Survey. Your participation is appreciated and vital to the success of my research.

This research project is being conducted by Christine Samson and Dr. Brian Ragan from the School of Applied Health Sciences and Wellness at Ohio University. There are no known risks other than that of everyday life to participate in this research study, nor are there any costs for your participation. All answers and your identity will remain confidential.

Your participation in this study is voluntary. If you choose to participate, please proceed to the survey: https://www.assessmentcenter.net/ac1/Assessments/Gait_Abnormalities_Clinical_Import ance_Survey.

If you have any questions about this research study, please contact Christine Samson at (702) 767-8213 or [email protected] or Dr. Brian Ragan at (740) 597-1876 or [email protected].

Respectfully,

Christine Samson, AT Ohio University Graduate student [email protected]

90 Appendix A-2: GACIS Consent Form

Ohio University Consent Form

Title of Research: Identifying Important Observed Clinical Gait Abnormalities

Researchers: Christine Samson, Kristine Kuntzleman, and Brian Ragan

You are being asked to participate in research. For you to be able to decide whether you want to participate in this project, you should understand what the project is about, as well as the possible risks and benefits in order to make an informed decision. This process is known as informed consent. This form describes the purpose, procedures, possible benefits, and risks. It also explains how your personal information will be used and protected. Once you have read this form and your questions about the study are answered, you will be asked to participate in this study. If you would like a copy of this document please contact Christine Samson or Dr. Brian Ragan. Explanation of Study

This study is being done to identify if there are gait abnormalities considered to be more clinically important by practicing clinicians while observing an individual’s gait cycle. In addition, the study will identify if there is a preference among clinicians when assessing for gait abnormalities with respect to the plane of view and the speed of the gait cycle.

If you agree to participate, you will be asked to complete the Gait Abnormalities: Clinical Importance Survey. The survey provides a list of common gait abnormalities and their definition. You will be asked to rate the clinical importance for each of the gait abnormalities. Then you will identify which view you are more likely to observe an individual for each gait abnormality. Finally you will be asked to identify if you are more likely to observe an individual for the gait abnormality while he or she is walking, jogging, or running.

You should not participate in this study if you are not a practicing Certified Athletic Trainer.

Your participation in the study will last for the time duration it takes you to complete and submit the Gait Abnormalities: Clinical Importance Survey, approximately 15 minutes.

Risks and Discomforts

There are no anticipated risks or discomforts other than those of everyday life.

91 Benefits

You may not personally benefit by participating in this study.

This study is important to scientific community to provide a better understanding of which gait abnormalities practicing clinicians observe for when completing a gait analysis.

Confidentiality and Records

Your study information will be kept confidential through the use of Patient Reported Outcomes Measurement System (PROMIS). No personal identifying information is collected. All data is kept confidential.

Additionally, while every effort will be made to keep your study-related information confidential, there may be circumstances where this information must be shared with: * Federal agencies, for example the Office of Human Research Protections, whose responsibility is to protect human subjects in research; * Representatives of Ohio University (OU), including the Institutional Review Board, a committee that oversees the research at OU.

Contact Information

If you have any questions regarding this study, please contact Christine Samson at (702)767-8213 or [email protected] or Dr. Brian Ragan at (740)597-1876 or [email protected].

If you have any questions regarding your rights as a research participant, please contact Jo Ellen Sherow, Director of Research Compliance, Ohio University, (740)593-0664.

By agreeing to participate in this study, you are agreeing that:  you have read this consent form (or it has been read to you) and have been given the opportunity to ask questions and have them answered  you have been informed of potential risks and they have been explained to your satisfaction.  you understand Ohio University has no funds set aside for any injuries you might receive as a result of participating in this study  you are 18 years of age or older  your participation in this research is completely voluntary you may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you and you will not lose any benefits to which you are otherwise entitled.

Version: [10/22/12]

92

Appendix A-3: Gait Abnormalities: Clinical Importance Survey

Joint Definition Jogging (J) terior View (A) terior Running (R) Walking (W) Lateral View View (L) Lateral Gait Abnormality An Posterior View (P) Posterior Rate of Clinical Rate (CI) Importance EXAMPLE Abnormality Definition 4 X X

FOOT/ANKLE CI A P L W J R Decrease or increase width Distance between the points of contact of base of support (step of both feet is greater or less than 2-5 width) inches Observed in initial contact or loading response; increases forward Excessive dorsiflexion progression During stance phase, majority of lateral aspect of foot comes in contact Excessive lateral contact with ground During stance phase, majority of medial aspect of foot comes in contact Excessive medial contact with ground

93

Observed at initial contact; ankle should be in neutral or slightly Excessive plantarflexion plantarflexed During initial contact and loading response; lateral forefoot comes in contact with ground causing elevation Excessive supination of 1st metatarsal head Internal rotation of foot during stance phase; more than 1st digit can be seen Excessive toe-in from A/P view External rotation of foot during stance phase; more than 5th digit can be seen Excessive toe-out from A/P view Simultaneous floor contact of forefoot Flat-foot contact and heel Foot lowered abruptly (uncontrolled) during stance phase after initial Foot slap contact Excessive; seen throughout stance Hindfoot supination phase Occurs from initial contact to loading Hyperpronation response through terminal stance Observed from heel off through Lateral heel whip preswing Observed from heel off through Medial heel whip preswing Observed during terminal stance and preswing; may cause inadequate knee No heel off flexion during swing phase

94

Premature heel rise Elevation of heel during midstance Step length problems Shortening of step length Failure to raise foot adequate distance from ground during initial swing to Toe drag clear toes On toes during stance phase in order Vaulting for swing leg to clear the ground KNEE CI A P L W J R Flexion of knee is lost during stance Excessive knee extension phase During loading response to clear toes of swing limb from ground; during midswing to clear swing limb from Excessive knee flexion ground During stance phase; a rapid backward motion (extension) without Extensor thrust hyperextending Observed during midstance and terminal stance, often associated with excessive ankle dorsiflexion OR Inadequate knee extension during terminal swing Decreased flexion during swing phase; normally 30⁰-60⁰ for walking and Inadequate knee flexion >90⁰ in sprinting Observed during initial contact Knee hyperextension through loading response Any part of swing limb crosses the Swing leg across midline midline of the body

95

Also referred to as "buckling of knee," small alternating instances of flexion and extension during initial contact Wobble through loading response HIP CI A P L W J R Swing leg is swung in outward direction to avoid contact with the Circumduction ground Observed during the stance phase; assists with foot clearance especially Excessive abduction with a leg length discrepancy Observed throughout the gait cycle; foot clearance may be affected during Excessive adduction swing phase During midswing to provide toe Excessive hip flexion clearance Seen during weight-bearing; may assist with foot clearance and/or Excessive external rotation advancement of swing limb Observed in either the stance phase or Excessive internal rotation swing phase Pelvis is lifted on affected side during Hip hiking swing phase During terminal stance; hip does not Inadequate hip extension reach desired extension During swing phase, makes difficult for toe clearance Inadequate hip flexion

96

POSTURE CI A P L W J R

During early stance phase, forward flexion of trunk; can affect one side during stance phase of limb or both Anterior trunk bending sides Varying degrees of lumbar lordosis, peaking at end of the affected limb's Increased lumbar lordosis stance phase During stance phase, trunk bends towards supporting limb; Lateral trunk bending "Trendelenburg gait" Posterior trunk bending Trunk extends or moves posteriorly

97 Appendix B-1: ROGAT Volunteer Walker Photo/Video Release

PHOTOGRAPH RELEASE FORM

DATE: ______

I, ______, hereby give my permission for photographs and/or videos of me to reprinted and/or used in the development of the Reliability: Observational Gait Analysis Tool (ROGAT). ROGAT will be administered as an evaluative tool for the following study, Establishing Reliability for the Identification of Clinically Important Observed Gait Abnormalities.

I understand that my name will remain confidential.

Signature of Subject: ______

Signature of Primary Researcher: ______

98 Appendix B-2: ROGAT Volunteer Walker Physical Examination Chart

Name of Walker: Sex: Age: Ethnicity: Activity level: FOOT RIGHT LEFT COMMENTS Toe Deformities Plantar callus formation Pes Cavus Pes Planus Calcaneovalgus Calcaneovarus Navicular Drop Feiss Line ANKLE RIGHT LEFT COMMENTS Dorsiflexion Plantarflexion Inversion Eversion Calf Girth: mid-muscle belly KNEE RIGHT LEFT COMMENTS Genu Valgum Genu Varum Genu Recurvatum Posterior knee crease (standing): angle vs. horizontal Knee flexion Knee extension HIP RIGHT LEFT COMMENTS Anteversion Retroversion Pelvic Rotation: relationship between ASIS and PSIS Hip flexion with knee extension Hip flexion with knee extension and plantarflexion Hip flexion with knee flexion Hip extension with knee extension Hip extension with knee flexion to 90o Hip internal rotation Hip external rotation

99 Hip abduction Trendelenburg test Rectus femoris contracture test Leg Length difference: True Leg Length difference: Anatomical INJURY HISTORY

100 Appendix B-3: ROGAT Recruiting Email

Dear Practicing Athletic Trainer:

I am writing to request your assistance with my research. An association has been made in the literature between various gait abnormalities and specific injuries in runners. As part of my research, I will be evaluating the abilities of clinicians to reliably identify clinically important gait abnormalities during a video observational gait assessment to establish inter-rater and intra-rater reliability.

Please take approximately 40 minutes out of your busy schedule to complete the Reliability: Observational Gait Analysis Tool (ROGAT). Your participation is appreciated and vital to the success of my research.

In order to establish intra-rater reliability, or the ability of the same clinician to consistently reproduce the same results, all participants will be asked to complete ROGAT a second time approximately two weeks after the initial completion of ROGAT. You will be eligible to win one of two $30 gift cards after the successful completion of ROGAT on the two separate occasions previously described.

This research project is being conducted by Christine Samson and Dr. Brian Ragan from the School of Applied Health Sciences and Wellness at Ohio University. There are no known risks other than that of everyday life to participate in this research study, nor are there any costs for your participation. All answers and your identity will remain confidential.

Your participation in this study is voluntary. If you choose to participate, please proceed to ROGAT: https://ohio.qualtrics.com/SE/?SID=SV_57GoehT8gUXnHLf&Preview=Survey&BrandI D=ohiochsp

If you have any questions about this research study, please contact Christine Samson at (702) 767-8213 or [email protected] or Dr. Brian Ragan at (740) 597-1876 or [email protected].

Respectfully,

Christine Samson, AT Ohio University Graduate student [email protected]

101 Appendix B-4: ROGAT Consent Form

Ohio University Consent Form

Title of Research: Establishing Reliability for the Identification of Clinically Important Observed Gait Abnormalities

Researchers: Christine Samson and Brian Ragan

You are being asked to participate in research. For you to be able to decide whether you want to participate in this project, you should understand what the project is about, as well as the possible risks and benefits in order to make an informed decision. This process is known as informed consent. This form describes the purpose, procedures, possible benefits, and risks. It also explains how your personal information will be used and protected. Once you have read this form and your questions about the study are answered, you will be asked to participate in this study. If you would like a copy of this document please contact Christine Samson or Dr. Brian Ragan.

Explanation of Study

This study is being done to identify the reliability or the ability of practicing clinicians to consistently identify clinically important gait abnormalities during an observational gait assessment conducted through video. The reliability among clinicians, or inter-rater reliability, and of the same clinician, or intra-rater reliability, will be evaluated.

If you agree to participate, you will be asked to complete the Reliability: Observational Gait Analysis Tool (ROGAT). You will complete a brief training session prior to the completion of ROGAT to become oriented with the gait abnormalities you will be asked to identify and the tool. The gait abnormalities you will be asked to identify were determined by the results from the Gait Abnormalities: Clinically Important Survey (GACIS) in a previous study. The multiple videos of ROGAT were filmed with the models walking in different planes of view. You will be asked to identify all of the gait abnormalities present within each video. If there are no abnormalities present, no boxes should be marked.

You should not participate in this study if you are not a practicing Certified Athletic Trainer.

Your participation in the study will last for the time duration it takes you to complete and submit the Reliability: Observational Gait Assessment Tool (ROGAT) on two separate occasions. The first session will take approximately one (1) hour to complete both the training session and ROGAT and the second session will take approximately 40 minutes if you choose not to review the training session a second time. The total estimated time to

102 complete both sessions is 100 minutes. In order to establish intra-rater reliability, all participants will be instructed to take ROGAT a second time two weeks after the first completion.

Risks and Discomforts

There are no anticipated risks or discomforts other than those of everyday life. Benefits

You may not personally benefit by participating in this study.

This study is important to scientific community to provide a better understanding of the reliability among practicing clinicians and of the same clinician to identify clinically important gait abnormalities when completing a gait assessment.

Confidentiality and Records

Your study information will be kept confidential through the use of method of test distribution. All data is kept confidential. It is necessary to obtain your email address in order for you to complete ROGAT a second time to determine intra-rater reliability, this will be the only identifying information collected.

Additionally, while every effort will be made to keep your study-related information confidential, there may be circumstances where this information must be shared with: * Federal agencies, for example the Office of Human Research Protections, whose responsibility is to protect human subjects in research; * Representatives of Ohio University (OU), including the Institutional Review Board, a committee that oversees the research at OU.

Compensation

You will be entered into a raffle for a chance to win one of two $30 giftcards after successful completion of ROGAT the first time and again at least two weeks after the first completion. If ROGAT is only completed once, you will not be eligible to win one of the two giftcards.

Contact Information

If you have any questions regarding this study, please contact Christine Samson at (702)767-8213 or [email protected] or Dr. Brian Ragan at (740)597-1876 or [email protected].

If you have any questions regarding your rights as a research participant, please contact Jo Ellen Sherow, Director of Research Compliance, Ohio University, (740)593-0664.

103

By agreeing to participate in this study, you are agreeing that:  you have read this consent form (or it has been read to you) and have been given the opportunity to ask questions and have them answered  you have been informed of potential risks and they have been explained to your satisfaction.  you understand Ohio University has no funds set aside for any injuries you might receive as a result of participating in this study  you are 18 years of age or older  your participation in this research is completely voluntary  you may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you and you will not lose any benefits to which you are otherwise entitled.

Version Date: [12/12/2013]

104 Appendix B-5: ROGAT Educational Training Session PowerPoint

105

106

107

108

109

110 Appendix B-6: ROGAT Sample Questions

111

112

113 Appendix C-1: DISTLE Standardized Patient Photo/Video Release

Sample Patient: PHOTOGRAPH RELEASE FORM

DATE: ______

I, ______, hereby give my permission for photographs and/or videos of me to be reprinted and/or used in the development of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE). DISTLE will be administered as an evaluative tool for the following study, Establish Validity for the Clinical Application of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE).

By agreeing to serve as a sample patient to test the validity of DISTLE, a sample patient profile will be created for clinicians to evaluate your gait, or the way you walk. The only clinicians who will have access to your sample patient profile are those who have agreed to participate in the study mentioned above. They will not be allowed to discuss any findings from your profile. Your sample patient profile will consist of demographic information (age, level of activity, common areas of pain when running, etc.) and your walking videos. The clinician will identify all of your gait abnormalities present based on the information provided within your sample profile.

The purpose of the proposed study is to determine if DISTLE is a valid and reliable tool that will allow clinicians to perform gait assessments in a different geographical location than their patient. This has been proposed to meet the need of increasing the accessibility of gait assessments conducted by clinicians to the running population in the hopes of reducing injury in the long run.

I understand that my name will not be used as an identifier for the information collected to create my sample profile and all other information will remain confidential.

Signature of Subject: ______

Printed Name of Subject: ______

Signature of Primary Researcher: ______

Version: [01/31/14]

114 Appendix C-2: DISTLE Survey Portion

115

116

117

118 Appendix C-3: DISTLE Standardized Patient Physical Examination Chart

Name of Walker: Sex: Age: Ethnicity: Activity level: FOOT RIGHT LEFT COMMENTS Toe Deformities Plantar callus formation Pes Cavus Pes Planus Calcaneovalgus Calcaneovarus Navicular Drop Feiss Line ANKLE RIGHT LEFT COMMENTS Dorsiflexion Plantarflexion Inversion Eversion Calf Girth: mid-muscle belly KNEE RIGHT LEFT COMMENTS Genu Valgum Genu Varum Genu Recurvatum Posterior knee crease (standing): angle vs. horizontal Knee flexion Knee extension HIP RIGHT LEFT COMMENTS Q-Angle Anteversion Retroversion Pelvic Rotation: relationship between ASIS and PSIS Hip flexion with knee extension Hip flexion with knee extension and plantarflexion Hip flexion with knee flexion Hip extension with knee extension Hip extension with knee flexion to 90o Hip internal rotation

119 Hip external rotation Hip abduction Trendelenburg test Rectus femoris contracture test Leg Length difference: True Leg Length difference: Anatomical INJURY HISTORY

120 Appendix C-4: DISTLE Recruiting Email

Dear Practicing Athletic Trainer:

I am writing to request your assistance with my research. An association has been made in the literature between various gait abnormalities and specific injuries in runners. As part of my research, I will be evaluating the clinical application of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) for the identification of gait abnormalities by practicing clinicians through a video store-and-forward assessment tool.

DISTLE is a tool that has been developed with the intent to increase the accessibility of clinician conducted gait assessments to the running population regardless of geographical location.

The study takes approximately 130 minutes to complete the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) assessment system. You will have the option to complete the DISTLE assessment system in installments, by saving and returning to the survey at a later time at specified break points, or to complete it in one session.

All interested persons will be screened prior to participating in the study. Those who will be asked to participate in the study will be the first four practicing athletic trainers with less than five years of experience and the first four practicing athletic trainers with five or more years of experience to complete the screening tool.

Your participation is appreciated and vital to the success of my research. All participants will be compensated with $30 for the successful completion of the study.

This research project is being conducted by Christine Samson and Dr. Brian Ragan from the School of Applied Health Sciences and Wellness at Ohio University. There are no known risks other than that of everyday life to participate in this research study, nor are there any costs for your participation. All answers and your identity will remain confidential.

Your participation in this study is voluntary. If you choose to participate, please proceed to the DISTLE participant screening questionnaire: https://ohiochsp.qualtrics.com/SE/?SID=SV_afOq23UB9OcDIH3

If you have any questions about this research study, please contact Christine Samson at (702) 767-8213 or [email protected] or Dr. Brian Ragan at (740) 597-1876 or [email protected].

121 Appendix C-5: DISTLE Participant Screening Survey (Screenshot)

122 Appendix C-6: DISTLE Consent Form

Ohio University Consent Form

Title of Research: Establishing Validity for the Clinical Application of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE)

Researchers: Christine Samson and Brian Ragan

You are being asked to participate in research. For you to be able to decide whether you want to participate in this project, you should understand what the project is about, as well as the possible risks and benefits in order to make an informed decision. This process is known as informed consent. This form describes the purpose, procedures, possible benefits, and risks. It also explains how your personal information will be used and protected. Once you have read this form and your questions about the study are answered, you will be asked to participate in this study. If you would like a copy of this document please contact Christine Samson or Dr. Brian Ragan. Explanation of Study

This study is being done to validate the use of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) by clinicians for the identification of a patient’s gait abnormalities through the use of video. With the use of both subjective and objective information for a patient, DISTLE has the potential to serve as an online store-and- forward telemedicine approach to gait assessments. Upon validation of DISTLE, the accessibility to gait assessments for runners across the country could potentially increase exponentially.

If you agree to participate, you will be asked to complete the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) assessment system. You will complete a brief training session prior to the completion of DISTLE to become oriented with the gait abnormalities you will be asked to identify and the tool itself. The gait abnormalities you will be asked to identify were determined by the results from the Gait Abnormalities: Clinically Important Survey (GACIS) and the Reliability: Observational Gait Assessment Tool (ROGAT) in previous studies. The multiple videos of the DISTLE assessment system were filmed with the sample patients walking in different planes of view. You will be asked to identify all of the gait abnormalities present within each video. If there are no abnormalities present, the designated box “No abnormalities found” should be marked.

If you agree to participate, please respect the confidentiality of the information that will be disclosed within each of our sample patient profiles.

123 You should not participate in this study if you are not a practicing Certified Athletic Trainer.

Your participation in the study will last for the time duration it takes you to complete and submit the DISTLE assessment system. The educational training session will take approximately twenty (20) minutes to review prior to the completion of the DISTLE assessment system. The completion of both the educational training session and the entire DISTLE assessment system will take approximately 130 minutes. You will have the option to complete the DISTLE assessment system in installments, by saving and returning to the survey at a later time at specified break points, or to complete it in one session.

Risks and Discomforts

There are no anticipated risks or discomforts other than those of everyday life.

Benefits

You may not personally benefit by participating in this study.

This study is important to the running community with respect to increasing the accessibility of clinician conducted gait assessments regardless of geographical location. Upon validation and application of the Dynamic Injury Screening Tool for the Lower Extremity (DISTLE) many runners would have access to gait assessments that could potentially decrease the occurrence of running related injuries (RRIs).

Confidentiality and Records

Your study information will be kept confidential through the use of Qualtrics, an online survey software system. All data is kept confidential. It is necessary to obtain your email address in order for the primary researcher to contact you to provide you with your compensation after the successful completion of the study.

Additionally, while every effort will be made to keep your study-related information confidential, there may be circumstances where this information must be shared with: * Federal agencies, for example the Office of Human Research Protections, whose responsibility is to protect human subjects in research; * Representatives of Ohio University (OU), including the Institutional Review Board, a committee that oversees the research at OU.

Compensation

All participants will receive a $30 compensation for the successful completion of the DISTLE assessment system.

124 Contact Information

If you have any questions regarding this study, please contact Christine Samson at (702)767-8213 or [email protected] or Dr. Brian Ragan at (740)597-1876 or [email protected].

If you have any questions regarding your rights as a research participant, please contact Jo Ellen Sherow, Director of Research Compliance, Ohio University, (740)593-0664.

By agreeing to participate in this study, you are agreeing that:  you have read this consent form (or it has been read to you) and have been given the opportunity to ask questions and have them answered  you have been informed of potential risks and they have been explained to your satisfaction.  you understand Ohio University has no funds set aside for any injuries you might receive as a result of participating in this study  you are 18 years of age or older  your participation in this research is completely voluntary  you may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you and you will not lose any benefits to which you are otherwise entitled. Version Date: [02/012/14]

125 Appendix C-7: DISTLE Educational Training Session PowerPoint

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129 Appendix C-8: DISTLE Sample Questions

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