CALIFORNIA STATE UNIVERSITY, NORTHRIDGE the Effects of Gait Training with Visual Feedback on Motor Outcomes in Individuals With

CALIFORNIA STATE UNIVERSITY, NORTHRIDGE

The Effects of Gait Training With Visual Feedback on

Motor Outcomes in

Individuals With Lower Limb Amputations

A thesis submitted in partial fulfillment of the requirements

For the degree of Masters of Science

In Kinesiology

Leora Tova Gabay

August 2014

The thesis of Leora Gabay is approved by:

______Mai Narasaki-Jara, M.S. Date

______Konstantinos Vrongistinos, PhD. Date

______Shane Stecyk, PhD., Chair Date

California State University, Northridge

DEDICATION

First and foremost, I could not have done any of this without G-d and my dear parents,

Maman and Papa, David and Reinette. No matter the hardships, I knew they were the

ones I could turn to for strength and support.

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ACKNOWLEDGEMENTS

To my siblings, Yaelle, Shelly, Ruthie and Shimon for being the best role models I could ask for. Dr. Shane Stecyk for rescuing me in my time of need. You are such a great chairperson and I consider myself eternally blessed to have worked with you. Dr. Dino Vrongistinos for your great words of wisdom and your cheery disposition. I appreciate your help. Mai (Mike and Miller) Jara for being my rhyme and reason and for always being a beacon of encouragement. For the last four years, I consider myself blessed to have the opportunity to work so closely with you. Dr. Vicky Graham, you have been such a big inspiration and part of this all. Your enthusiasm and love for what you do has inspired me to continue further and always seek to help others. Thank you endlessly. Armando Ayala, you have inspired me in ways you will never know. I admire your hard work and virtue to pursue anything you set your mind to. You are such a strong person I am forever grateful that we worked together. To Becky, Stacey, Larisa, Carol, Randy, Dr. Todd, Jennifer, Jessica, Carolyn, Byron, Gioella, and everyone at the Center of Achievement. You have been my family for the last four years and there is so much I have learned from you. ‘Thank you’ is not enough to express how you have helped me and made this experience so enjoyable. To Jae, Yumi, Ileana, Elizabeth Marie, Allison, Uby, Kelsea, Natalie, Alexis, Brenda and Takuto: I have learned so much from each one of you and I am so happy to be able to call you my friends. I hope you take advantage of the incredible opportunities you get at the CoA. Ask questions, learn stories, remember why you are here and keep your eyes on the prize. Always strive to do better but don’t compete with anyone; we are all on a different track. Stay strong and be there for each other. To Annie, words cannot express my gratitude for always being joyful and never thinking any task was too big. You are a wonderful research assistant and an even greater friend. Dr. Jung, for reinforcing that I can do anything I set my mind to. Lastly but not least, my participants and clients for making each day and each session an opportunity to grow and learn from you, to be inspired by you, to help others like you have helped me. You have contributed so much and I am thankful.

Thank you and May G-d bless you all! In loving memory of Mikhail ‘Austin’ Sandow

TABLE OF CONTENTS

Signature Page…………………………………………………………………….………i

Dedication…………………………………………………………………………………ii

Acknowledgements………………………………………….……………...……………iii

Abstract…………………………………………………………………………………..vi

INTRODUCTION…………………………………………………………….….……….1

LITERATURE REVIEW………………………………………………………...……….2

AMPUTATIONS………………………………………………………..………. 2

GAIT ………………………………………………..……………..……..………3

FUNCTION OF DIFFERENT PROSTHESIS ……………………………..…….3

AMPUTATIONS AND EXERCISE……………………………………………. 4

BIOMECHANICS OF DESIRED GAIT OF AMPUTEE ……………………….5

AMPUTATIONS AND GAIT AND BALANCE …………………...………….10

VISUAL FEEDBACK AND GAIT TRAINING ……………………………….12

MOTOR LEARNING BEHAVIOR……………………………………………..13

METHODS………………………………………………………………………………18

Participants ……………………………………………………….……..……….18

Setting…………………………………………………………………..………. 17

Data collection procedures ……………………………………………..……….19

Instrumentation …………………………..……………………………..……….20

Human Subjects Protocol………………………..……………………..………. 26

Analysis ……………………………………………….………………..……….26

RESULTS

Participant 1………………………………………...………………..…………..27

Participant 2………………………………………………………..……...……..30

Participant 3………………………………………………….……..……………33

Participant 4………………………………………………………..…………….36

DISCUSSION………………………………………………………..…………………..40

CLINICAL SIGNIFICANCE………………………………………………………..…..43

CONCLUSION………………………………………………………..…………………44

REFERENCES………………………………………………………..…………………45

APPENDIX A Figures …..…………………………………………..………………….48

APPENDIX B Human Subjects………………………………………………..………...73

Bill of Rights………………………………………………………..……………77

APPENDIX C Subject/Client Information…………………………………...………….78

ABSTRACT

THE EFFECTS OF GAIT TRAINING WITH VISUAL FEEDBACK ON MOTOR OUTCOMES IN INDIVIDUALS WITH LOWER LIMB AMPUTATIONS

Leora Tova Gabay

Master of Science in Kinesiology

Approximately 120,000 lower limb amputations are performed each year, and vascular diseases account for 70% (Davis et al., 2004). Many people with amputations regain their mobility using prosthetics, however, their gait patterns are significantly changed. Altered gait patterns such as asymmetrical loading and asymmetrical stance time can increase the risk of developing musculoskeletal complications (Lemaire et al., 1994).

In addition to orthopedic compromises, many people with lower limb amputations undergo challenging issues associated with their balance.

Exercise can help people with amputations improve their gait. A reduction in gait asymmetry has been documented with the implementation of exercise in amputees (Lloyd et al., 2010). Real time visual feedback has been shown to improve gait efficiency by diminishing energy consumption while walking at a steady pace on a treadmill along with reduced heart rate and improved in asymmetry (Davis et al., 2004).

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The use of a visual feedback system may be an effective way to retrain gait. The

Biodex Gait Trainer Treadmill has been used to assess and train gait performance in those with neurological gait dysfunctions. Instant visual feedback has been demonstrated to be effective in improving gait patterns among people with hemiparesis (Chen et al., 2004).

No research has examined the use of gait trainer with instant visual feedback as a form of retaining gait patterns in people with unilateral lower limb amputations. Therefore, the purpose of this study was to evaluate the effects of treadmill gait programs with and without visual feedback in individuals with lower limb amputations. A total of 4 participants were recruited for the study. The adults participated in an intervention for a total of 15 sessions. The program consisted of a warm up, 30-minute treadmill walk and a cool down. Participants were measured for kinematic gait parameters, spatial-temporal variables, balance variables and quality of life. Although there were no consistent patterns with the groups after the intervention, individual changes in kinematic, spatial- temporal, balance and quality of life variables presented individual improvements based on each participant’s current condition. These trends imply that a visual feedback treadmill exercise is an effective way to maintain and improve gait parameters, balance and quality of life in individuals with unilateral lower limb amputations.

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INTRODUCTION

Nearly two million people live with amputations, or a loss of limb, in the United

States and more than half of these people experience lower limb amputations. Lower limb amputation can adversely influence both balance and gait. People with lower limb amputations commonly endure difficulty in gait retraining post-amputation. Some issues that arise include a longer stance time on the unaffected leg (Jaegers, Aredzen, Jongh,

1995; James & Oberg, 1973), slower walking speed (Jaegers et al., 1995) asymmetrical gait patterns (Jaegers et al., 1995; James & Oberg, 1973; Murray, 1980; Zuniga et al.,

1972) and a lack of selective motor control (Kegel, Burgess, Starr, & Daly, 1981). To improve gait and balance for those with lower limb amputations, a prosthetic device is required to commence gait rehabilitation. For those who choose to receive a prosthetic limb, rehabilitation is necessary in order to ambulate properly post-amputation.

In order to retrain gait and improve balance, studies have investigated different methods of gait rehabilitation in individuals with altered gait patterns. Gait training with visual feedback has been shown to improve gait patterns in populations with a variety of disabilities such as stroke, cerebral palsy and spinal cord injury. Because previous studies show the improvements in gait through the use of visual feedback and virtual reality gait training, it is essential to look at the effects of gait training with visual biofeedback on motor outcomes for those with lower limb amputations. For the purpose of this study, investigation how visual feedback gait training with different populations improves motor outcomes in individuals with cerebral palsy or hemiplegia can be transferred to improving motor outcomes in individuals with unilateral lower limb amputations. The differences in gait between healthy and amputee populations, such as asymmetrical

1 loading and stance time can be modified using the visual feedback gait training mechanism, Additionally, the transfer of learning also applies to the transfer of technique for training from one population to another. To date, there is no study comparing the effects of gait training with visual feedback on the motor outcomes in individuals with unilateral lower limb amputations by using the Biodex Gait Trainer II. The results of this study may provide for practitioners to implement a new rehabilitation mechanism for individuals with lower limb amputations.

Literature Review

Amputations

An average of 185,000 amputations are performed yearly in the United States

(Ziegler-Graham, MacKenzie, Ephraim, Travison, & Brookmeyer, 2008). An amputation, or the loss of a limb, is a life-altering change often causing musculoskeletal imbalances.

(Davis, Ortolano, Richards, Redhed, Kuznicki, Sahgal, 2004; Gailey, Allen, Castles,

Kucharik, Roeder, 2008). Approximately 65% of the amputations are performed on the lower limbs (Davis et al., 2004). The two main types of lower limb amputations are transfemoral (TF), or above the knee, and transtibial (TT), or below the knee amputations.

Disarticulations, which are amputations of a joint such as the hip, knee and ankle, are also often seen. TT amputations involve an amputation above the ankle but below the knee.

With this type of amputation, full use of the knee is still available; however, it may be difficult for the individual to bear weight on the residual limb.

A TF amputation occurs between the hip and knee. Full body weight can no longer be placed on the residual limb. Many people with amputations may regain their mobility using prosthetics; however, their gait patterns are significantly altered. Altered gait patterns such as asymmetrical loading and stance time can increase the risk of developing musculoskeletal complications (Lemaire & Fisher, 1994). In addition to orthopedic compromises, many people with lower limb amputations undergo challenges associated with their balance. Although people with amputations often continue to lead healthy, active and long lives, there are often reports of back pain, osteoporosis or osteopenia after the amputation (Gailey et al., 2008). In order to minimize such effects, therapeutic interventions including strengthening, balance training and gait training are

3 often recommended in order to reduce asymmetry and stress on the contralateral and residual limb alike (Gailey, et al., 2008).

Gait

Gait is defined as a repetitive event of the lower limb that moves the body forward while simultaneously maintaining stance stability (Perry, 1992, p. 3; Houglum,

2005, p. 356. As defined by Pohl (1991), a gait cycle is the time between two successive occurrences of one of the repetitive events of walking. A complete gait cycle consists of two phases. In a normal gait pattern, approximately 62% of the gait cycle is spent in stance phase whereas the remaining 38% is spent in swing phase. The stance phase is the time in the gait cycle where the foot is in contact with the ground. The swing phase is the period of time where the foot is in the air. The stance phase consists of four parts: initial contact, loading response, mid-stance, and terminal-stance. On the other hand, there are three phases that comprise the swing phase: initial-swing, mid-swing, and terminal-swing

(Kirtley, 2006, p.16; Houglum, 2005, p.368).

Function of Different Types of Prosthesis

The ideal proceeding step after an amputation is to learn to ambulate with a prosthetic. A prosthetic device is intended to aid an individual with a lower limb amputation in ambulation so that they can perform activities of daily living post- amputation. There are several types of prostheses that can contribute to the facilitation of gait retraining. The most popular legs are microprocessor controlled knee joints for TF amputations. Such prosthetics facilitate the swing phase and terminal phase, allowing for better flexion of the knee joint and terminal extension (Schalz, Blumentrit & Jarasch,

2002). The C-Leg, an example of a microprocessor knee, offers adequate swing phase knee flexion, resistance and terminal knee extension during walking, especially at faster speeds (Bellmann, Schmalz & Blumentritt, 2010). The X3 by Ottobock is one of the most advanced prosthetic legs on the market, allowing for adaptability and facilitating almost natural gait motion. Prosthetics made for those with TT amputations are less complex as they do not have to compensate for the lack of a knee joint. Both prosthetic devices include a foot attached to a pylon which creates the ankle joint and allows for shock absorption.

Amputations and Exercise

Exercise can help people with amputations improve their gait. Sixteen individuals with unilateral TT amputations showed improvements in bilateral strength symmetry for knee flexion, knee extension and hip abduction movements with the implementation of strength exercises (Lloyd, Stanhope, Davis & Royer, 2010). Real time visual feedback has been shown to improve gait efficiency with diminished energy consumption while walking at a steady pace on a treadmill. Reduced heart rate and improved gait symmetry were also noted (Davis et al., 2004). In a case study where an individual had both a lower and upper limb amputations, a bi-weekly exercise regimen consisting of strength training, cardiovascular endurance and core stability training showed improvements in muscular strength and peak VO2 (Donachy, Brannon, Hughes, Seahorn, Crutcher, et al., 2004). On the other hand, Kegel and colleagues looked at the effects of isometric muscle training on the residual limb and if it improved strength and gait in four TT amputees. The results from this study indicated that isometric muscle contractions in the residual limb provides for a better fit for suspension of a prosthetic and is more useful in the gait rehabilitation

5 process (Kegel, Burgess, Starr, Daly, 1981). When compared to one another, all exercise interventions improved gait in individuals with a lower limb amputations. Different types of exercise such as strength training, cardiovascular endurance and balance training each have their benefits for improving quality of life in various populations with disabilities, including those with lower limb amputations.

Biomechanics of Desired Gait of Amputee

Whether an amputation is due to injury or congenital deformation, the loss of a limb is a traumatic experience. With the many types of prosthetic limbs available, the selection of prosthetic limbs can accommodate almost any type of lifestyle post- amputation. The goal of having an external appliance, such as a prosthetic, is to improve the user’s mobility and ability to perform daily functions (May, 2011 p. 12).

Gait for people without disabilities has been described in the literature.

Recommended gait biomechanics for amputees with prosthesis have also described and serve to improve gait efficiency. Researchers and clinicians believe that increased gait efficiency will improve the lives of amputees because they will be able to perform activities of daily living with less effort, fewer compensatory movements and experience less pain and fewer injuries. By understanding the importance of these factors, improvements in the walking patterns of individuals with lower limb amputations can be made to help them walk more like the healthy population instead of making unhealthy compensations to walk with their prosthetic. Through the use of visual feedback gait training, one is able to improve gait patterns in order to avoid making compensations in their walking.

Energy Efficiency

Energy efficiency is a critical component of effective movement. It is important to select a prosthetic that can aid the amputee in being energy efficient. According to Gailey

(1994), amputees already walk 11% slower and spend 16% more energy than non- amputee walkers. It has been reported that transtibial amputees are more energy efficient during gait and walk faster than transfemoral amputees, which can be expected since they have more of the organic limb intact (May, 2011, p. 110). Seroussi (1996) concluded that many adaptations are made on the residual side during stance phase, primarily the increase in muscular work for the hip extensors and ankle plantar flexors. This is due to the decreased push-off for the prosthetic side. Since the implementation of an exercise program can improve strength and flexibility, the muscles can be more effective, providing a healthier walking pattern. Depending on how the amputation was acquired, whether it was dyvascular or trauma related, also impacted the level of energy expenditure during gait. Patients with dyvascular amputation require more energy to ambulate. According to Schurr (p. 42, 2002), there is an increase in energy expenditure per meter walked post amputation. Attempting to walk the same distance at the same speed with an altered pattern movement would require a larger rate of energy expenditure and an overall increase in energy expenditure.

Potential for Injury

The potential for additional injury arises after a new amputee attempts to walk.

An amputation alone is a life altering event which requires the patients completely change how they move. Adding a prosthetic limb is another significant change that they must adjust for in activities of daily living and activity. These changes increase the risk of

7 injury. Injuries such as slipping or falling often occur when an amputee acquires a prosthetic limb. This can be detrimental to the rehabilitation process since an injury can severely impact the way a person relearns to walk.

Part of walking in normal gait is equal force distribution of both legs. This may prevent gait abnormalities, such as vaulting, trunk shifting and truncal deviations that may occur if there is too much of a force acting on one area. People with amputations who have learned to walk with prosthetics often have unequal force distribution on their legs, as an attempt to avoid excess forces on the residual limb. Having an amputation often results in other pathologies such as back pain, osteoarthritis and musculoskeletal problems (Gailey, 2008). These are often temporally alleviated by equally distributing forces on the legs, with more force on the intact limb.

The importance of equal force distribution can be seen in normal gait patterns.

According to Roerdink (2011), equal force distribution is not found in amputees because of losses in neural and proprioceptive mechanisms post-amputation. Amputee gait that is closer to normal gait is more ideal in rehabilitation. It will reduce the chances of additional altered gait patterns such as circumduction, excessive hip flexion and hip hike from occurring. Since the body is a kinetic chain, if one part of the body is compensating for another, additional compromises will occur and further harm the body. Through exercise and fitness, one can reduce the potential of further developing musculoskeletal compromises that may diminish energy efficiency and increase potential for injury.

Amputations and Gait and Balance

Typical gait patterns have been studied for many years in the healthy population.

Gait is considered a complex motor task that is defined as a fluid progression of the body allowed by proper coordination of limb movements. A common gait compensation of those with amputations is to load more force on the residual limb (Suzuki, 1972). Gait characteristics in those with lower limb amputations can be compromised when walking with a prosthetic in response to decreased volumes and forces of the stabilizing hip muscles (Jaegers et al., 1995). Other gait characteristics may include decreased walking speed, decreases in the lateral bend in the trunk toward the prosthetic side and the absence of a rebound of the hip at heel strike (Jaegers et al., 1995). Asymmetrical gait may be caused due to the lack of plantar flexion and normal range of motion in the ankle

(Breakey, 1976). Compared to healthy individuals, those with lower limb amputations have shown to have poorer balance and rely more on their residual limb in order to control static and dynamic movements (Isakov, Mizrahi, Ring, Susak, Hakim, 1994). Gait symmetry observed in the healthy population is considered to be one of the major factors that determines gait efficiency and speed (Patterson, 2010; Titianova, 2008). A lack of selective motor control as opposed to alternating muscle activation can also be seen in those with lower limb amputations (Kegel, 1981). In this sense, the pathological gait of a person with a TF or TT amputation is a reflection of the injury, weakness, loss of stability, possible pain or poor gait retraining mechanisms (Houglam, p. 375)

Regaining balance after a lower limb amputation can be a difficult task to achieve.

Those with lower limb amputations experience a loss of afferent nerve pathways which causes a distortion in somatosensory information (Quai, Braurer, Nitz, 2005).

Additionally, because of the lack of the biological ankle joint and its musculature, there may be a reduction in mobility and muscular strength. This may lead to an amputee’s inability to balance properly with the adjustments of their lower limb biomechanical constraints. Those with TT amputations lack plantar flexors in one limb having the knee extensors to become more involved and important in the forward progression (Powers,

1996). A bi-weekly intervention where participants partook in balance and strength exercises showed improvements in walking in the elderly with other disabilities

(Kawanabe, Kawashima, Sashimoto, Takeda, Sato et al., 2007). Maintaining balance and reducing the risk of falling can be achieved with a balance-training program.

Visual Feedback and Gait Training

Visual feedback gait training is a form of rehabilitation where the participant receives instant feedback, either from the system itself or from a therapist operating the system providing ways to improve their locomotion while walking on the treadmill.

Several types of visual feedback rehabilitation systems have been emerging and gaining popularity in recent times. Although there are several types of visual feedback, the most popular include the integrated virtual rehabilitation environment treadmill (IVERT); a front projection immersive environment (Feasel et al, 2011) and the computer assisted rehabilitation environment (CAREN), a virtual reality system providing real-time feedback displayed in front of the participant to improve biomechanical and physiological performance (Darter et al., 2011). Additionally, the Biodex Gait Trainer II allows for instant visual feedback by a built-in force plate located beneath the treadmill belt (Lewek, Feasel, Wentz, Brooks & Whitton, 2012). Visual feedback gait training systems stress the visual system by either moving the surroundings and/or the base of

10 support (ie. force plate). Improvements in clinical outcomes have been documented regardless of method of stressing the visual system.

The use of a visual feedback system can be an effective method to retrain gait. A virtual reality (VR) system has been used to help retrain those with TF amputations along with those suffering from strokes, traumatic brain injuries and spinal cord injuries (Feasel et al., 2011). The use of VR showed improvements in the frontal hip, pelvis and trunk motion during over-ground walking. In one case study, Darter et al (2011) implemented

12, 30 minute intervention sessions on the CAREN system for an individual with a unilateral TF amputation. Improvements in gait hip excursion, gait speed and asymmetry were noted. Using such a system may provide active learning by experimentation and direct feedback as opposed to inconsistent and qualitative feedback that a therapist might give a patient (Feasel et al., 2011).

Motor Behavior

Some may question the potential for improvement when looking at the effects of gait training with visual feedback on motor outcomes in individuals with lower limb amputations. This may be due to the lack of research in this field. However, other populations, such as stroke and people with cerebral palsy have improved gait using visual feedback. By applying the transfer of learning theory, the potential to improve gait parameters in people with lower limb amputations increases needs to be investigated.

Transfer of learning is the influence of prior learning on the learning of a new skill or the performance of a skill in a new context (Magill, 2007). Since improvements in gait have

11 been demonstrated in other populations, the transfer of learning theory provides some basis for us to infer similar improvement in other populations.

Additionally, the specificity of practice hypothesis indicates that learning a motor skill is influenced by practicing the condition characteristics, such as performance and cognitive processes involved. The performance plateau may also be a strong indicator of progress, looking at how much time has elapsed from the time of the amputation to the time of gait rehabilitation. Characteristics, such as time since amputation, type of amputation and age when amputation may have been acquired are also important to consider when looking at how the participants may react to a certain intervention.

Components of Visual Feedback

One element that makes visual feedback highly effective is the use of optic flow.

Optic flow is the motion sensed at the eye as the body moves through its environment, which can be important in controlling gait speed and stride length (Lamontagne, Fung,

McFadyen & Faubert, 2007; Prokop, Schubert & Berger, 1997). The use of a visual feedback treadmill walking has been investigated on various populations such as people post-stroke and the elderly with osteoarthritis. Another system besides the previously mentioned CAREN is the IVERT, an immersive system, provides feedback on the treadmill screen. The Biodex Gait Trainer Treadmill is a device that uses visual feedback to indicate the gait cycle of the participant. It is used to assess and train gait performance in those with neurological gait dysfunctions. The visual feedback screen is placed on a deck, monitoring gait parameters such as step length, walking speed and step symmetry.

The Biodex Gait Trainer treadmill was effective in improving gait patterns among people

12 with hemiparesis (Chen, Pattern, Kothari & Zajac, 2005). In contrast to the IVERT or

CAREN, the Biodex Gait Trainer II does not provide a fully immersive visual feedback system.

Generally speaking, treadmill walking has been an effective way to improve gait in rehabilitation. In a study looking at gait parameters in individuals post stroke, there was an improvement in single limb support time on the affected limb along with diminished energy costs and leg kinetic energy at the toe-off (Chen et al., 2005). Five individuals with hemiparesis improved speed and symmetry using the integrated virtual environment rehabilitation treadmill (IVERT) system after a single training session lasting between 20 and 40 minutes (Feasel et al., 2011). A bi-weekly training session (30 to 40 minutes each session) using a robotic assisted gait rehabilitation treadmill increased angles in the hip joint during stance phases. The 12 subjects reported that the visual feedback improved motivation and concentration as well, and felt that the feedback was consistent (Banz, Bollinger, Colombo, Dietz & Lunenburger, 2008). This system increased the patients’ motor output as detected by electromyography.

The Biodex Gait Trainer II, using instant biofeedback, was used in a study investigating thirty children with spastic hemiparesis cerebral palsy (Gharib, El-

Maksoud, & Rezk-Allah, 2011). In another study, significant improvements after 6 weeks showed an increase in average step length, walking speed, time on each foot and ambulation index. Gait training has also been effective in improving dynamic balance in children with Down syndrome in a three-month treatment study (El-Meniawy, Kamal,

Elshemy, 2012). In contrast to other exercise interventions of a longer duration, a single bout of exercise using speed-dependent treadmill training or limited progressive treadmill

13 training in individuals with Parkinson’s disease can improve speed and stride length

(Pohl, 2003).

Summary

The amount of amputations occurring per year is astonishing. Whether the amputation was congenital or acquired, an amputation is a life-altering event. Often times, the mobility related ramifications from an amputation include altered gait patterns and diminished balance. To avoid this, studies show that exercise, particularly gait training, can improve motor outcomes in people with unilateral lower limb amputations.

Gait training with visual feedback has shown promising improvements in many populations. Many studies have compared the effects of different types of visual feedback gait training. However, these previous studies have not looked at the effects of visual feedback with instant biofeedback such as that used in the Biodex Gait Trainer II treadmill as means to improve motor outcomes in those with lower limb amputations. As a result, this study investigated the changes in motor outcomes such as gait and balance in those with unilateral lower limb amputations following an intervention using the Biodex

Gait Trainer II treadmill with instant biofeedback.

Consequently, the hypothesis for this study was that those who participate in a walking intervention using the Biodex Gait Trainer II treadmill would improve motor outcomes post-intervention. Although some may argue that treadmill walking is not completely a reflection of how an individual performs on land, it has nonetheless been demonstrated to be an effective form of gait retraining and rehabilitation.

METHODS

Participants

Participants were recruited through word of mouth and outreach from local prosthetics, orthotists, kinesiotherapists and physical therapists. All participants had a unilateral lower limb amputation for at least two years at the beginning of the intervention. All participants received a medical clearance to exercise from a physician.

Inclusion criteria are as follows: a) age: 18-65 years old, b) medical diagnosis of a unilateral transfemoral or transtibial amputation, c) current prosthetic is comfortable and does not inhibit walking, d) ability to walk comfortably for a minimum of 15 minutes, e) ability to follow test and training procedures, and f) must obtain medical clearance.

Exclusion criteria are as follows: a) acute orthopedic injury, b) major surgery within 6 months, c) cardiorespiratory complications, d) unbearable stump pain during exercise.

Table 1: Participant physical characteristics information

Height Weight M/F Age Side/ Year of Type of (m) (kg) (years) Level Amputation Prosthetic 1 1.75 79.2 M 59 Left A 2011 X2 2 1.65 63.8 M 52 Right B 1990 Egad 3 1.75 91 M 30 Left A 2008 X3 4 1.63 109.5 F 27 Left A 2005 C-Leg

Setting

The study was conducted at the Center of Achievement (COA) at California State

University, Northridge. The intervention was held in the main equipment room, using the

Biodex Gait Trainer II treadmill (gait trainer and conventional treadmill settings). Three-

Dimensional gait analysis took place in the laboratory of the COA. Gait kinematics were

15 used to test range of motion at the hip (and knee for transtibial). Velocity, cadence, stance and swing phase and stride length were measured as well. A total of 2 data collection sessions were complete: pre-intervention and post-intervention.

Data Collection

Participants arrived for data collection at the Center of Achievement (COA) at

California State University, Northridge. Prior to data collection, they received a copy of the informed consent. The informed consent and bill of rights were read to the participant and signed. Additionally, participant demographic information was taken (Appendix C) and the participant completed the pre-intervention SF-36 questionnaire. The participant then changed into comfortable exercise clothing and their anthropometric measures were recorded. The individual was then escorted to the gait laboratory where reflective markers were placed on 15 landmarks as per the Plug-In Gait Model (SACR). Markers were placed on the sacrum, and bilaterally on the anterior-superior iliac spine, thigh, lateral epicondyle of the femur, tibia, lateral maleoulus, calcaneus and head of the second metatarsal. Buttons (2011) suggests placing reflective markers on “equivalent positions on the prosthetic limb.” The participant walked across a 10-meter walkway for data collection as fast as they could, with a self-determined resting period between trials. Each participant walked for 5-15 trials in order to collect the required data. After the gait trials were taken, the participant rested and was given water before beginning the balance test.

The safety harness was clipped onto the Neurocom Balance Manager and the slack was adjusted so that the clip was about a 45° angle. The data were voided if the participant lost their balance by moving their foot, held the harness, and/or touched the wall throughout the trials. If the participants moved their foot, the graduate researcher

16 repositioned the foot back to the designated area before the next trial began. The researcher ensured that participants stood with proper foot placement, their safety harness was attached, and active spotter was in place prior to the trials.

All participants preformed the Sensory Organization Test (SOT) first. All six conditions were completed in the same order. The second test was the Motor Control Test

(MCT). This test consisted of two conditions. The participants were asked to keep their balance while the force plate unexpectedly moved posterior for three trials followed by three trials of unexpected anterior translation. The last test was the Limits of Stability

(LOS). The participant was displayed on the screen in front of them as a black dot. They had to then reach a flashing target by shifting their weight to have the black dot meet the target.

Intervention

All participants participated in 15 (3x a week for 5 weeks) sessions of the intervention. Each session began with a warm up (5-10 minutes), treadmill walk (30 minutes) and a cool-down (5-10 minutes). Both the warm up and cool down exercises consisted of the following: a) stretching, b) parallel bar exercises (hip extensions, weight shifts), c) ascending and descending steps, d) bike, e) Nu-Step, or f) walking. Depending on which group the participant was randomly selected, he or she was either walking on a gait trainer treadmill or a conventional treadmill. Participants on the visual feedback gait trainer treadmill were constantly reminded to keep their eyes on the screen in front of them and follow the feedback.

Instrumentation

GAIT

Upon completion of the screening process, participants underwent a gait assessment at their maximal walking speed. Anthropometric measurements were taken from each individual according to the requirements for static and dynamic modeling. The walkway consisted of a 10-meter indoor walkway. The dependent variables evaluated were spatial-temporal and kinematic variables including cadence, stride length, stance vs. swing ratio and maximal gait velocity, hip excursion, knee excursion (for transtibial amputees).

Eight infrared motion analysis camera system (VICON, Oxford, UK, 2010) were used to collect 3-D data before and after the intervention. Fifteen reflective markers were used to signify bony landmarks on participants’ body using the Vicon Plug-in Gait model

(SACR). Additionally, a digital camera was used when collecting data. Data was processed using the Nexus Data Processor, viewed in Polygon and imported through

Microsoft Excel. Three subjects used the Biodex Gait Trainer treadmill and one used a conventional treadmill setting.

BALANCE

The Neurocom Balance Manger (Smart Balance Master, Neurocom International,

Clackamas, OR, 2010) is a computerized posturalgraphic balance assessment machine.

This machine consists of dual dynamic forceplates and a moveable surrounding that can correlate with the movement of the forceplates or exaggerate the movement of the forceplates. Three tests were completed in the following order for all data collection

18 session: Sensory Organization Test (SOT), Motor Control Test (MCT), and Limits of

Stability (LOS).

SOT: This test consisted of six conditions designed to evaluate three proprioceptive systems: somatosensory, visual and vestibular. Each test within the SOT (6 tests in total,

3 trials per test) combined tasks with conditions as follows: eyes open, eyes closed, moveable forceplate, moveable surroundings and a combination of the conditions.

MCT: This test was designed to evaluate the participant’s involuntary reaction to anterior and posterior translations (small, medium and large).

LOS: This test was designed to test how quickly a participant can react to move their body to a highlighted target (reaction time).

Table 2: Neurocom Tests

Measurement Test Definition Equilibrium SOT The Equilibrium Score was calculated using the participant’s maximum anterior and posterior sway from each trial of the SOT tests divided by the maximum sway possible, which was multiplied by 100 to create a percentage. The equation was as follows:

Equilibrium Score = 12.5-(Max AP COG Dis – Min AP COG Dis) * 100 12.5

(AP = Anterior to Posterior)

Ankle Strategy SOT Strategy is the relative amount of movement about the ankles (ankle strategy) and about the hips (hip strategy) used to maintain balance. Weight MCT Weight symmetry is the involuntary distribution of weight on each foot during an unexpected movement of the force Symmetry plate in either anterior or posterior translations of the force plate. A score of 200 indicates complete weight bearing on the right leg while a score of 0 indicates complete weight on the left leg. A score of 100 indicates equal weight bearing. Reaction Time LOS The time between the signal to move and the initiation of the movement expressed in seconds. Directional LOS The amount of movement in the intended direction toward Control the target minus the amount of extraneous movement off axis, expressed as a percentage.

Table 3: NeuroCom Balance Manager Tests and Descriptions

TEST CONDITION DESCRIPTION Sensory Condition One Participant stands quietly, facing Organization Test forward, hands to their sides and eyes closed Condition Two Participant stands quietly, facing forward, hands to their sides and eyes closed Condition Three Participant is asked to stand on the force plate with eyes open, while looking at a moving visual surrounding. Condition Four Participant stands on a moveable force plate, quietly with their hands to their sides, eyes open on the visual surrounding. Condition Five Participant stands on the force plate, quietly with their hands to their sides, eyes closed. Condition Six Participant stands on the force plate quietly while force plate and visual surrounding move.

Motor Control Anterior Small Small force plate perturbation in the Test Translations forward direction Anterior Medium Medium force plate perturbation in the Translations forward direction Anterior Large Large force plate perturbation in the Translations forward direction Posterior Small Small force plate perturbation in the Translations backward direction Posterior Medium Medium force plate perturbation in the Translations backward direction Posterior Large Medium force plate perturbation in the Translations backward direction Limits of Stability Forward Right forward Right direction Directional control using body lean in Right back carious directions towards a target Back direction displayed in front of a participant Left back Left direction Left Forward (Smart Balance Master, Neurocom International, Clackamas, OR, 2010)

QUALITY OF LIFE

The Rand SF-36 is a health questionnaire measuring physical and mental health status in relation to eight health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health.

Table 4: Rand SF-36 Health Questionnaire Components

Component of Health Questionnaire Activities of Component

Physical functioning (PH) Vigorous activities, moderate activities, lift and carrying groceries, climb several flights, climb one flight, bend, kneel, walk a mile, walk a block, bathe and dress Role-physical (PH) Cut down time, accomplished less, limited in kind, had difficulty Bodily pain (PH) Pain-magnitude, pain-interference

General health (PH) EVGFP rating, sick easier, as healthy as others, expectation of health to decline, health is excellent Vitality (MH) Full of life, energy, worn out, tired

Social functioning (MH) Social-extent, social-time

Role-emotional (MH) Cut down time, accomplished less, less careful Mental health (MH) Nervous, down in the dumps, peaceful, depressed and downhearted, happy

Human Subjects’ Protocol:

This study protocol was approved by the University Human Subjects Review Board. All participants were made aware of any potential risks involved in participation and they signed the informed consent before participation.

Analysis:

No statistical analysis was derived from the data. The number of participants was not enough to elicit a power analysis and therefore the study is an individual case study.

RESULTS

Participant 1

Participant 1 was a 59-year-old male who suffered a left leg above-the-knee amputation after a motor vehicle accident in 2011. He received his prosthetic limb shortly thereafter along with minimal physical therapy lasting only a couple of months. He was a moderately active individual, who enjoyed running as a form of exercise before his amputation. He is currently using the Ottobock X2 leg.

Participant 1 had never exercised on a treadmill. He had never in a gait research study before and was skeptical about any possible gait improvements because he believed that too much time had elapsed since the loss of his leg. Prior to the intervention, the participant had expressed that he wanted to gain more range of motion in his hips in order to be able to sleep on his stomach. On the first day of the intervention, his comfortable treadmill walking speed was at 1.2 miles per hour (mph). By the last day of the intervention, he had voluntarily increased his speed to 1.6 mph. He had a more symmetrical gait pattern by spending a more equal amount of time on each leg, beginning at 67% on the right left and only 35% on his left prosthetic leg. This number equalized more towards the end of the intervention coming it to 57% on the right and 43% of time on the left.

Participant 1 required a single point cane to ambulate prior to the intervention. By the end of the intervention, he stated that he only used the cane when he was going uphill and felt comfortable walking without it. He had contacted me multiple times throughout the intervention to let me know about milestones he had achieved such as having walked

24 around the house the whole day without his cane or having escalated a flight of stairs with minimal use of the handrail. He felt increasingly confident in his abilities to walk on his own as the intervention progressed. Additionally, the participant felt encouraged to continue his physical activity and enrolled for therapeutic exercises at the Center of

Achievement in order to further continue his physical wellbeing.

Gait

Participant 1 showed slight improvements in hip excursion. At baseline testing, he showed greater hip flexion than at post-intervention testing, deviating from his goal.

Additionally, at post intervention testing a decrease in slope (on the hip excursion graph) was noted during the gait cycle. At baseline testing, more hip flexion at the heel strike phase of gait was present. Participant 1 decreased in hip flexion angles from 49.7° to

45.4°. His post-test hip flexion angle is closer to hip flexion angles of the healthy population.

Total cadence and individual cadence for each leg increased. Total cadence increased by 7.7% from 104 to 112 steps per minute. Cadence of the amputated limb improved by 6.7% from 105 to 112 steps per minute.

Participant 1 showed increases in stride length for both the affected and non- affected legs (8.7% and .82% respectively) from 1.15 meters to 1.25 meters and 1.22 to

1.23 meters per stride, indicating a more symmetrical stride length. Stride symmetry increased by 4%, from 94% to 98% (longest stride length divided by shorter stride length divided by 100).

Stance phase decreased. At baseline, the stance to swing ratio was 61:39 only to move to 59:41, deviating slightly from the average ratio of 62:38.

Maximal gait velocity increased. At baseline, maximal gait velocity was recorded at 1.01 meters per second, increasing by 15.8% to 1.17 meters at post-intervention collection.

Balance

SOT: In the SOT test, equilibrium and ankle strategy were tested. Participant 1 showed a slight increase in the composite score, increasing from 82 to 84. Condition One, Two,

Four, Five and Six showed improvements in averaged equilibrium scores at post- intervention. Condition Three was the only condition to show a decrease of 6.6% in the equilibrium scores. Improvements in ankle strategy were noted after the intervention.

Pre-intervention showed that he used the ankle strategy 84.67% of the time and increased to 88% of ankle strategy after the intervention.

MCT: In this test, weight symmetry was measured. Weight symmetry increased by 21.8% in the posterior translations and an increase of 34.4% was noted for anterior translations.

Posterior translations averaged 121, decreasing to 94.6 post-intervention while anterior translations averaged 121 to decreasing to 90 for weight symmetry.

LOS: In the LOS test, reaction time and directional control were tested. Participant 1 decreased reaction time for transitions 1 and 8 by 72% and 21% respectively. However, the other 6 conditions showed increase in reaction time. Directional control increased from 76% to 78.75%.

Quality of Life

Participant 1 completed the SF-36 questionnaire computing the 8 components of physical and mental health. Both overall physical and mental health improved for

Participant 1. Overall physical health improved by 37.5% from a score of 34.6 to 47.6.

Overall mental health improved by 20.2% from 44.5 to 53.51.

Participant 2

Participant 2 was a 52-year-old male who lost his right leg in 24 years ago in a motor vehicle accident. His leg was amputated below-the-knee. He received his prosthetic leg shortly thereafter. He attended minimal therapy at the time of his amputation but regularly attends the local gym. Participant 2 had his prosthetic limb for the longest amount of time compared to all of the participants. He felt that he was able to ambulate fine prior to the gait training but was always looking at more ways to improve his physical activity levels. He is an active individual who frequents the gym, mainly for a stationary bike. Additionally, he was the only individual with a below the knee amputation.

From the beginning, it was apparent that participant 2 would not benefit from the training as much due to his length of time since amputation. This may be related to the performance plateau, which indicates that at a certain point, a person’s improvements will cease to increase. Since it had been 20 years since his amputation, it was highly likely that he would experience this. Participant 2 felt comfortable on the treadmill from the beginning. He was frequently distracted during the interventions and had to often be reminded to keep his eyes on the screen in order for the feedback to be administered

27 properly and as affectively as possible. This is important because the bio-feedback intervention was contingent on the participant applying the feedback from the treadmill to improve their gait pattern. Having the participant pay attention to the feedback is a fundamental part of the rehabilitation.

Participant 2 noticed throughout the intervention that he was stronger in his terms and had more endurance during work than he had prior to the commencement of the intervention. Participant 2 had increased his comfortable walking speed on the treadmill from 1.3 mph to 1.8 mph by the end of the intervention. Additionally, he had been spending more equal time on his legs, beginning at 55% on his right and 45% on his left to 49% on his right and 51% on his left during the end of the intervention. Having a general understanding of what gait is encouraged him to want to partake in the study, as he understood the importance that research has on new mechanisms for rehabilitation. He continued to go to the gym after completion of the study and said that physical activity will always be an integral part of his life.

Participant 2 showed no apparent improvements in hip excursion. Additionally, as the study’s only transtibial case, participant 2 showed increases in knee flexion at heel strike. He began the study with 0 degrees of extension at heel contact and completed the study with 6 degrees of flexion at heel strike. He deviated from the healthy norm of 0° of flexion at the knee at heel strike.

Total cadence did not improve drastically for participant 2. Total cadence showed no increase in steps per minute. However, left leg cadence improved by 0.88% from 114 to 115 steps per minute.

Participant 2 showed increases in stride length for both the non-affected and affected legs (8.54% and 6.25% respectively) from 1.60 meters to 1.70 meters and from

1.64 to 1.78 meters per stride. Stride symmetry decreased by 2%, from 98% to 96%.

Stance phase increased. At baseline, the stance to swing ratio was 59:41 and post- intervention ratio was 64:36. This shows an overall increase in stance time on the affected leg (right).

Velocity increased from baseline to post-intervention. At baseline, maximal gait velocity was recorded at 1.49 meters per second, increasing by 7.4% to 1.60 meters at post-intervention collection.

Balance

SOT: In the SOT test, equilibrium and ankle strategy were tested. Participant 2 showed an increase in the composite score, increasing from 70 to 75. Condition Two, Three and

Four showed improvements in averaged equilibrium scores at post-intervention.

Condition One, Five and Six showed a decrease in averaged equilibrium scores. This indicates that the participant possessed an ineffective use of the somatosensory and vestibular cues. Ankle strategy remained the same. Pre-intervention data showed that he used the ankle strategy 84.6% of the time and increased to 84.83% of ankle strategy after the intervention.

MCT: In this test, weight symmetry was measured. Weight symmetry had increased for posterior translations by 16.5% and for anterior translation to increase by 45.5%.

Posterior translations averaged at 70.3, decreasing to 58.7 post-intervention while anterior translations averaged at 80.7 to decrease to 44 for weight symmetry.

LOS: In the LOS test, reaction time and directional control were tested. Participant 2 decreased reaction time for transitions one, two and six by 3.5%, 69.5% and 51% respectively. However, reaction times for the other 3 conditions increasee. Directional control increased from 75.75% to 80.75%.

Quality of Life

Participant 2 completed the SF-36 questionnaire computing the 8 components of physical and mental health. Overall physical health did not improve, both pre and post scores were 49.1. Overall mental health improved by 0.1%.

Participant 3

Participant 3 was a 30 year old male who suffered a left leg above-the-knee amputation after a motor vehicle accident in 2008. He received his prosthetic limb shortly thereafter and had approximately 3 months of physical therapy. He is currently using the

Ottobock X3 leg. Participant 3 was a highly active individual. He was only 23 years old when he lost his leg and contributes a lot of his walking success to the fact that his physical therapist never gave up on him. He himself is going to school to become a physical therapist and says that he loves doing gait research, whether it is in the gait lab at the Veteran Affairs hospital or at this institution.

Participant 3 used a standard treadmill without any form of feedback. He enjoyed walking on the treadmill but often pushed himself in order to have a faster comfortable rate. This would sometimes effect his walking and would leave him with back pain. After suggesting that he walk slower to be more efficient and avoid back pain from the impact, he slightly lowered his velocity from 2.1 to 1.8 miles per hour and treated the walk like a

30 stroll. From the beginning, he seemed to have been more able than the other participants.

However, participant 3 had been going through various psychological difficulties at the time of the intervention. He mentioned multiple times that he is not a quitter and will go through the intervention because it is something he started and will finish. Additionally, there were some days where he would come into the session and had a poor vibe in his attitude. The researcher actively ignored the negative attitude and immediately presented new topics for discussion. Toward the middle of the intervention, the participant began seeking psychological assistance and had alerted me that some days would be more difficult than others with regard to how he felt and he told me that he might be emotional.

Yet, he refused to quit and proceeded to complete the intervention.

Participant 3 had notified the researcher that he felt like he could last longer during activities of daily living and had more endurance. Additionally, he liked the environment in which the exercise interventions were taking place and enjoyed the company of the research assistants. He would speak to them about the therapeutic exercise education process and says that it was a privilege to have been part of the research which will hopefully enhance the field of amputation gait retraining.

Participant 3 showed slight increases in hip excursion, from 32° to 34° post-intervention.

Although this occurred, the overall trend in hip excursion was noted to be smoother during the gait cycle, with less fluctuations in flexion and extension post-intervention.

This was determine by the difference in the slope of the hip excursion graph.

Total cadence and individual cadence for each leg decreased for participant 3.

Total cadence showed a decrease of 0.01% from 140 to 138 steps per minute. Left leg cadence, however, improved by 2.0% from 138 to 141 steps per minute.

Participant 1 showed increases in stride length for both the affected and non- affected legs (8.7% and .82% respectively) from 1.15 meters to 1.25 meters and 1.22 to

1.23 meters per stride, providing a more symmetrical gait than prior to the intervention.

Stride symmetry increased by 1%, from 98% to 99%.

The time spent in stance phase increased after the intervention. At baseline, the stance to swing ratio was 62:38, which is the swing to stance ratio for health individuals.

At post-intervention, the stance to swing ratio was 67:33.

Velocity increased from baseline to post-intervention. At baseline, maximal gait velocity was recorded at 1.98 meters per second, increasing by 1.0% to 2.00 meters at post-intervention collection.

Balance

SOT: In the SOT test, equilibrium and strategy were tested. Participant 3 exhibited a decrease in the composite equilibrium scores, decreasing from 86 to 83. Condition One and Six showed improvements in averaged equilibrium scores at post-intervention.

Condition Two, Three, Four and Five showed a decrease in averaged equilibrium scores.

This indicates that the participant possessed an ineffective use of the visual, somatosensory and vestibular cues. Ankle strategy remained the same. Pre-intervention showed that he used the ankle strategy 82.39% of the time and increased only to 82.61% of ankle strategy after the intervention.

MCT: In this test, weight symmetry was measured. Weight symmetry had increased by

17% in the posterior translations and an increase of 4.0% was noted for anterior translations. This indicates that after the intervention, the participant was distributing more weight on his affected side; however, he was distributing his weight more to the residual limb post-intervention. Posterior translations averaged 111.3, and increased to

130.0 post-intervention while anterior translations averaged 146.6 and decrease to 140.6.

LOS: In the LOS test, reaction time and directional control were tested. Participant 3 decreased reaction time for transitions 1,3 and 8 by 45%, 58.9% and 84% respectively.

However, the other 3 conditions showed increase in reaction time by up to 269.5% in

Condition Six. Directional control increased from 70% to 80.25%.

Quality of Life

Participant 3 completed the SF-36 questionnaire computing the 8 components of physical and mental health. Overall physical health improved from 55 to 57.3. Mental health, however, decreased over 15 points from 61.8 to 45.1 points.

Participant 4

Participant 4 is a 27 year old female who suffered from a left leg above-the-knee amputation in 2005 due to a medical condition. She received about 9 months of physical therapy after the acquisition of her prosthetic leg. She is not currently physically active.

She wears a C-Leg.

Participant 4 had not been on a treadmill since the loss of her leg when she was in her late teenage years. In order to ambulate on her college campus, participant 4 compensated to increase her walking speed to get to her classes on time. She noted that her campus was on a hill and she compromised her posture in order to refrain from falling. When she had her daughter years later, she always put her weight on the stroller and felt that she became dependent on the stroller. As a result, she was not able to stand on her own without assistance. Initially, she had told me that all her other therapists had made her walk on a treadmill and she came to despise it. She also did not feel motivated when it came to rehabilitation as she felt that she had tried everything and nothing worked. At first she was putting a lot of weight on her arms by using the sidebars on the treadmill. By the third week, she progressed to simply placing her hands on the bar for minimal support. The client noted that she had more endurance when playing with her daughter, felt more flexible in her hips and felt as though she had more erect standing and sitting postures. Participant 4 felt as though she had a lot more room to improve, even though prior to the intervention she had felt that rehabilitation was a lost cause at that point. She would often inform the participants of small progresses she had noticed, such as being able to walk more without consuming as much energy. When she first began the intervention, participant 4 was walking at 1.0 miles per hour and on the last session was

34 able to increase her comfortable speed to 1.9 miles per hour. She was spent 34% of the gait cycle on her left leg and 66% on her right leg in the first week and progressed to 45% and 55% of the gait cycle on her left and right legs, respectively. She enrolled at a local

YMCA and began routine physical activity post-intervention.

Participant 4 increased hip excursion. After the intervention, participant 4 increased hip excursion by approximately 30°; pre-intervention - 35.3° and post- intervention - 65.7°. However, at post-intervention, hip flexion and extension excursions were not as smooth during the gait cycle.

Total cadence and individual cadence for each leg increased for participant 4.

Total cadence showed an increase of 7.02% from 114 to 122 steps per minute. Left leg cadence improved by 7.96% from 113 to 122 steps per minute.

Participant 4 showed increases in stride length for both the affected and non- affected legs (10.94% and 24.14% respectively) from 0.64 meters to 0.71 meters and 0.58 to 0.72 meters per stride. Stride symmetry increased by 7%, from 91% to 98%.

Stance phase improved from baseline to post-intervention testing. At baseline, the stance to swing ratio was 54:46, later improving to 57:43.

Velocity displays an increase from baseline to post-intervention. At baseline, maximal gait velocity was recorded at 1.23 meters per second, increasing by 18.7% to

1.46 meters for the left leg at post-intervention collection.

Balance

SOT: In the SOT test, equilibrium and strategy were tested. Participant 4 exhibited an increase in the composite equilibrium scores, increasing from 72 to 82. Condition Two,

Three and Five showed improvements in averaged equilibrium scores at post- intervention. Condition One remained equal whereas Condition Four and Six showed a decrease in averaged equilibrium scores. This indicates that the participant possessed an ineffective use of the visual and vestibular cues. Strategy showed that the participant used more ankle strategy after the intervention. Pre-intervention showed that she used the ankle strategy 71.1% of the time and increased to 82.3% of ankle strategy after the intervention.

MCT: In this test, weight symmetry was measured. Weight symmetry improved by 17% in the posterior translations and an increase of 4.0% was noted for anterior translations.

This indicates that after the intervention, the participant distributed more weight on his affected side; however, he was not equally distributing his weight post-intervention.

Posterior translations averaged 120.3, and decreased to 107.3 post-intervention, while anterior translations averaged119.3 and decreased to 112.6 which notes a change in weight symmetry.

LOS: In the LOS test, reaction time and directional control were tested. Participant 4 decreased reaction time for all transitions except for transition 3. Improvements were noted from 4.7% in transition one to 165% in transition 8. Transition 3 showed an increase in reaction time by 503.6%. Directional control increased from 71.13% to 74%.

Quality of Life

Participant 4 completed the SF-36 questionnaire computing the 8 components of physical and mental health. Overall physical health improved from 22.1 to 28.1. Overall mental health also improved from 60.9 to 61.7.

DISCUSSION

The purpose of this study was to investigate the effects of gait training with visual feedback on motor outcomes in individuals with lower limb amputations. It was hypothesized that the 5-week intervention would elicit improvements in all variables tested, including cadence, stride length, stance versus swing ratio, maximal gait velocity, static and dynamic balance and quality of life measurements.

The results from four participants in this study suggested that a 5-week intervention of gait training with visual feedback may have a positive effect on motor outcomes in individuals with transfemoral lower limb amputations. Several improvements were observed in gait spatial-temporal and kinematic variables along with static and dynamic balance and quality of life. Uncontrolled variables that may have affected the outcome measures must be taken into consideration. For example, age of amputation, length of residual limb, length of time since amputation and condition of amputation (dyvsascular or traumatic injury). When an amputation is acquired at a younger age, an individual may be more able to make changes and adapt to the circumstances. Often times when an infant or younger individual has an amputation, they are able to adapt better than those who lived a longer life and then had the amputation at a later age. This can be a component that can affect the rehabilitation process.

It has been documented that the length of the residual femur substantially influences spatial-temporal kinematic gait outcomes after a transfemoral amputation

(Bell, 2013). Those with shorter limb lengths had greater excursion in the torso and the pelvis. Because limb length was not measured in this study, no conclusive information can be derived to determine whether the information is applicable to this study.

Gait

Various gait parameters were observed in all four participants; however, each participant had a different combination of components what showed improvement.

Research suggests that each individual with an amputation has various elements that may affect their improvement (Feasel, 2011). Schurr (2002) indicates that patients with dyvascular amputations are more likely to expend more energy during when ambulation compared to traumatic acquisitions. It is important to consider the length of time of the intervention. A longer intervention may provide greater improvements in the variables tested.

Data suggest that the level of amputation will indicate whether the participant will improve their spatial-temporal variables. Participant 2, the only transtibial amputee, did not show improvements in overall cadence. Additionally, (participant 3) showed decreases in total cadence. This may be due to the use of a conventional treadmill as opposed to the treadmill with visual feedback. The visual feedback treadmill is designed to improve gait patterns through a combination of calculations that determine what the stride length should be for the participant based on inputted height and age along with detected weight. The conventional treadmill does not provide such feedback and permits the user to walk without feedback or constructive instruction.

All participants elicited longer stride lengths after their intervention due to the feedback given on the treadmill. The settings on the treadmill prompted the participants to take longer stride lengths on the treadmill. This translated into having longer stride length in the post-test. The two transfemoral amputees who had participated in the visual

39 feedback gait training portion elicited the greatest improvements in spatial-temporal variables than conventional treadmill user and the transtibial amputee. The only participant to elicit improvements in kinematics was participant 1, who showed improvements in hip excursion to be closer to that of the healthy population (30° hip flexion at heel strike). All other excursions had increased, deviating from the norm, including knee excursion for participant 2. This may indicate an increase in joint flexibility due to the treadmill walking. The improvements in results concur with results from previous researchers, highlighting the positive effects of gait training with visual feedback (Feasel et al., 2001; Darter et al., 2011, Chen et al., 2005 & Pohl, 2003).

Improvements in gait were made because the treadmill’s feedback forced the participant to make certain compensations in order to place their foot correctly corresponding with the suggested placement of the foot on the treadmill screen. Based on height and age, a certain step length was determined, which put the participant out of their comfortable walking pattern, forcing elongated strides. On the contrary, the one participant who used a convention treadmill did not elicit improvements in stride length.

Spatial temporal variables may have improved in the visual feedback group due to the precise location the foot was placed.

Balance

After a 5-week intervention, balance had improved in different areas for all participants. All participants showed an improvement in ankle strategy, relying more on their residual limb’s ankle than previously. With better balance, the participants were able to rely more on their ankle. As a result, longer stride lengths and an increase in cadence

40 were reported. Participants distributed more weight on their affected side, although not always more equally. After each session, participants were shown the percentage of time spent on each foot generated by the treadmill. This made them more cognizant of their weight distribution and where they would need to adjust. This translated as beneficial in the long run as post-testing showed an improvement in weight distribution. Equilibrium had improved for all intervention participants. It was noticed that participants were placing more weight on their affected side, bringing their weight symmetry closer to

100%, indicating more equal weight distribution. All participants had elicited improvements in directional control. An improvement in ankle strategy from walking on the treadmill was able to better aid the participants in controlling their center of mass, improving directional control. Treadmill walking has been known to improve core stability, therefore increasing balance and directional task control.

Quality of Life

Participants showed an improvement in quality of life after the intervention.

Stagnant scores were due to participants’ length of time since amputation. The participant with the longest amount of time with a prosthetic limb and the youngest age of acquisition had no changes in his scores. Because this participant was already accustomed to and comfortable with his prosthetic limb, mental state of mind was not improved with exercise. However, for those who did not know their limits of physical activity and ability, the exercise showed them that they were able to do a lot more than they thought they could, resulting in higher mental and physical health scores. As the research has indicated, it is possible to improve quality of life, even without consistent patterns noted in the gait and balance portion of the study.

Adherence

Each participant had 100% adherence rate during the gait intervention. Adherence policies were addressed during the orientation in order to notify the participant of what would be required for the study. Make-up days were required if one of the participants could not attend one of the sessions. The adherence rate may have been due to the supportive relationship/environment developed between the participant and researcher.

Additionally, participants reported an immediate success and feeling more able after the first intervention date, encouraging them to want to continue with the training.

Limitations with Data Collection Procedures

When using the assessment tools, multiple issues arose due to the nature of the study. The prosthetic limb was not detected on the NeuroCom test for latency. All participants mentioned that the stance required for the NeuroCom tests was uncomfortable. Feet positioning had to be fixed with each test. For the NeuroCom, all participants had to wear shoes due to possible slipping of the prosthetic foot. Participants were advised to wear non-slip shoes for the testing.

Future Research

Further investigation is needed to validate any of the claims made. A larger sample size with a larger randomized control would give the research more credibility.

Future studies may also consider dividing the study into types of amputation such as transfemoral or transtibial. Participants’ maximal and comfortable speeds can also be measured in order to determine whether spatial-temporal variables caused compensatory motions. A longer intervention would provide adequate time for participants to adapt to

42 the training. Testing maximal and comfortable walking speeds can give the researcher a better idea as to what gait compensatory patterns the participants make in order to increase speed. Additionally, a follow up would better indicate the long term effects of such a program.

Conclusion

The results of this data suggest that individuals with unilateral lower limb amputations can benefit from gait training with visual feedback. Individual improvements can be seen in gait, balance and quality of life for participants. The interpretation of the outcomes of this study must be limited due to the nature of the case study along with the large variability in the physical and technological conditions of individuals with lower limb amputations and prosthetics. Clinicians may consider the improvements of this study’s participants when retraining gait in individuals with lower limb amputations. The study findings can contribute to building scientific evidence on the use of a real time visual feedback gait trainer treadmill as a form of gait retraining and rehabilitation for individuals with unilateral lower limb amputations.

As previously mentioned in the results, all participants quality of life had improved. This occurred regardless of clinical measures. Based on these outcomes, it may be more appropriate to focus on individual clinical measures instead of large statistical results. This would require more patience from the providers

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APPENDIX A

PARTICIPANT 1:

Cadence 140

120

100

steps per minute 40

0 Baseline Post

Figure 1: Cadence for Participant 1

Stride Length 1.26 1.24 1.22 1.2 1.18 Le meters 1.16 Right 1.14 1.12 1.1 Baseline Post

Figure 2: Stride Length for Participant 1

Maximal Gait Velocity 1.2

1.15

1.1

1.05 Le Right 1 meters/second

0.95

0.9 Baseline Post

Figure 3: Maximal gait velocity for participant 1

Gait Cycle

Stance Swing

Post 59 41

Pre 61 39

Gait Cycle

Figure 4: Stance vs. swing ratio for Participant 1

Hip Excursion

60 → 50

) Flexion 40 °

30 Pre Post 20

10 Extension Degree ( ←

0 Gait Cycle

Figure 5: Hip excursion for Participant 1

Equilibrium 100 90 80 70 60 50 40 Baseline 30 Post-Intervenon 20 10 0

Figure 6: SOT Equilibrium for Participant 1

Ankle Strategy 100 90 80

70 60 50 40 30 20 10

0 Baseline Post-Intervenon Figure 7: SOT Ankle strategy for Participant 1

Weight Symmetry 200 180 160 140 120 100 Baseline 80 Post-Intervenon 60 40 20 0 Posterior Anterior

Figure 8: MCT Weight Symmetry for Participant 1

Reacon Time 1.6 1.4 1.2 1 0.8

seconds 0.6 Baseline 0.4 Post-Intevenon 0.2 0

Figure 9: LOS Reaction time for Participant 1

Direconal Control 100 90 80 70 60 50 40 Baseline percentage 30 20 Post-Intevenon 10 0

Figure 10: LOS Directional Control for Participant 1

Component Pre-Intervention Post-Intervention Physical functioning 15 50 Role-Physical 25 100 Bodily Pain 41 100 General Health 97 62 Vitality 45 80 Social Functioning 62.5 75 Role-Emotional 0 66.7 Mental Health 72.0 84 Overall Physical Health 34.6 47.6 Overall Mental Health 44.5 53.5 Figure 11: Physical and mental health results for Participant 1

PARTICIPANT 2:

Cadence 120

100

60 Cadence Parcipant 2 40 steps per minute 20

0 Baseline Post

Figure 12: Cadence for Participant 2

Stride Length 1.8

1.75

1.7

1.65 Le meters Right 1.6

1.55

1.5 Baseline Post

Figure 13: Stride length for Participant 2

Maxiamal Gait Velocity 1.65

1.6

1.55 Le

1.5 Right meters/second 1.45

1.4 Baseline Post

Figure 14: Maximal gait velocity for Participant 2

Gait Cycle

Stance Swing

Post 64 36

Pre 59 41

Gait Cycle

Figure 15: Stance vs swing ratio for Participant 2

Hip Excursion 50

→ 40

30 ) Flexion ° 20 Pre Post 10

Extension Degree ( -10

← Gait Cycle

Figure 16: Hip excursion for Participant 2

Knee Excursion

50 → 40

30 ) Flexion ° 20 Pre

10 Post 0

-10 Extension Degree (

← -20 Gait Cycle

Figure 17: Knee excursion for Participant 2

Equilibrium 100 90 80 70 60 50 40 Baseline 30 20 Post-Intervenon 10 0

Figure 18: SOT Equilibrium for Participant 2

Ankle Strategy 100 90 80 70 60 50 40 30 20 10 0 Baseline Post-Intervenon

Figure 19: SOT Ankle strategy for Participant 2

Weight Symmetry 200 180 160 140 120 100 Baseline 80 Post-Intervenon 60 40 20 0 Posterior Anterior

Figure 20: MCT Weight symmetry for Participant 2

Reacon Time 2.5

1.5

seconds 1 Baseline

0.5 Post-Intevenon

Figure 21: LOS Reaction time for Participant 2

Direconal Control 100 90 80 70 60 50 40 Baseline percentage 30 20 Post-Intevenon 10 0

Figure 22: LOS Directional Control for Participant 2

Component Pre-Intervention Post-Intervention Physical functioning 90 85 Role-Physical 100 100 Bodily Pain 51 62 General Health 92 82 Vitality 80 90 Social Functioning 100 100 Role-Emotional 100 100 Mental Health 92 88 Overall Physical Health 49.1 49.1 Overall Mental Health 60.8 61 Figure 23: Physical and Mental health results for Participant 2

PARTICIPANT 3:

Cadence 140.5

140

139.5

139

138.5

steps per minute 138

137.5

137 Baseline Post

Figure 24: Cadence for Participant 3

Stride Length 1.74

1.73

1.72

1.71 Le

meters 1.7 Right 1.69

1.68

1.67 Baseline Post

Figure 25: Stride Length for Participant 3

Maximal Gait Velocity 2.02

1.98

1.96 Le 1.94 Right 1.92 meters per second 1.9

1.88 Baseline Post

Figure 26: Maximal gait velocity for Participant 3

Gait Cycle

Stance Swing

Post 67 33

Pre 62 38

Gait Cycle

Figure 27: Stance vs swing ratio for Participant 3

Hip Excursion 50

→ 40 30 20 ) Flexion ° 10 Pre 0 Post -10 -20 -30 Extension Degree ( Gait Cycle ←

Figure 28: Hip excursion for Participant 3

Equilibrium 100 90 80 70 60 50 40 Baseline 30 20 Post-Intervenon 10 0

Figure 29: SOT Equilibrium for Participant 3

Ankle Strategy 100 90 80 70 60 50 40 30 20 10 0 Baseline Post-Intervenon

Figure 30: SOT Ankle strategy for Participant 3

Weight Symmetry 200 180 160 140 120 100 Baseline 80 Post-Intervenon 60 40 20 0 Posterior Anterior

Figure 31: MCT Weight strategy for Participant 3

Reacon Time 1.4 1.2 1 0.8 0.6

seconds Baseline 0.4 Post-Intevenon 0.2 0

Figure 32: LOS Reaction time for Participant 3

Direconal Control 120 100 80 60 Baseline

percentage 40 20 Post-Intevenon 0

Figure 33: LOS Directional control for Participant 3

Component Pre-Intervention Post-Intervention Physical functioning 100 90 Role-Physical 100 100 Bodily Pain 100 74 General Health 77 87 Vitality 95 95 Social Functioning 100 62.5 Role-Emotional 100 33.3 Mental Health 100 80 Overall Physical Health 55 57.3 Overall Mental Health 61.8 45.1 Figure 34: Physical and mental health results for Participant 3

PARTICIPANT 4:

Cadence 124

122

120

118

116 Cadence Parcipant 4

steps per minute 114

112

110 Baseline Post

Figure 35: Cadence for Participant 4

Stride Length 0.8 0.7 0.6 0.5 0.4 Le meters 0.3 Right 0.2 0.1 0 Baseline Post

Figure 36: Stride Length for Participant 4

Maximal Gait Velocity 1.5 1.45 1.4 1.35 1.3 Le 1.25 Right

meters per second 1.2 1.15 1.1 Baseline Post

Figure 37: Maximal gait velocity for Participant 4

Gait Cycle

Stance Swing

Post 57 43

Pre 54 46

Gait Cycle

Figure 38: Stance vs swing ratio for Participant 4

Hip Excursion

80 → 70 60 ) Flexion ° 50 40 Pre 30 Post 20 10 Extension Degree (

← 0 Gait Cycle

Figure 39: Hip excursion for Participant 4

Equilibrium 100 90 80 70 60 50 40 Baseline 30 20 Post-Intervenon 10 0

Figure 40: SOT Equilibrium for Participant 4

Ankle Strategy 100 90 80 70 60 50 40 30 20 10 0 Baseline Post-Intervenon

Figure 41: SOT Ankle strategy for Participant 4

Weight Symmetry 200 180 160 140 120 100 Baseline 80 Post-Intervenon 60 40 20 0 Posterior Anterior

Figure 42: MCT Weight symmetry for Participant 4

Reacon Time 1.8 1.6 1.4 1.2 1 0.8 Baseline 0.6 0.4 Post-Intevenon 0.2 0

Figure 43: LOS Reaction time for Participant 4

Direconal Control 100 90 80 70 60 50 40 Baseline 30 20 Post-Intevenon 10 0

Figure 44: LOS Directional Control for Participant 4

Component Pre-Intervention Post-Intervention Physical functioning 25 30 Role-Physical 0 50 Bodily Pain 64 51 General Health 35 42 Vitality 50 70 Social Functioning 62.5 75 Role-Emotional 100 100 Mental Health 84 80 Overall Physical Health 22.1 28.1 Overall Mental Health 60.9 61.7 Figure 45: Physical and Mental health results for Participant 4

Participant 1 Pre Post Total Cadence 104 steps per minute 112 steps per minute Left Right Left Right Cadence 105 steps 103 steps 112 steps 111 steps Stride Length 1.15 m 1.22 m 1.25 m 1.23 m Maximal Gait Velocity 1.01 m/s 1.04 m/s 1.17 m/s 1.13 m/s Stance vs. Swing Ratio 61:39 59:41

Participant 2 Pre Post Total Cadence 112 steps per minute 112 steps per minute Left Right Left Right Cadence 114 steps 109 steps 115 steps 108 steps Stride Length 1.60 m 1.64 m 1.70 m 1.78 m Maximal Gait Velocity 1.53 m/s 1.49 m/s 1.63 m/s 1.60 m/s Stance vs. Swing Ratio 59:41 64:36

Participant 3 Pre Post Total Cadence 140 steps per minute 138 steps per minute Left Right Left Right Cadence 138 steps 143 steps 141 steps 135 steps Stride Length 1.73 m 1.69 m 1.70 m 1.72 m Maximal Gait Velocity 1.98 m/s 2.01 m/s 2.00 m/s 1.93 m/s Stance vs. Swing Ratio 62:38 67:33

Participant 4 Pre Post Total Cadence 114 steps per minute 122 steps per minute Left Right Left Right Cadence 113 steps 114 Steps 122 steps 121 steps Stride Length .64 m .58 m .71 m .72 m Maximal Gait Velocity 1.23 m/s 1.22 m/s 1.46 m/s 1.45 m/s Stance vs. Swing Ratio 54:46 57:43

APPENDIX B California State University, Northridge CONSENT TO ACT AS A HUMAN RESEARCH PARTICIPANT

The Effects of Gait Training with Visual Feedback on Motor Outcomes in Individuals with Lower Limb Amputations

You are being asked to participate in a research study. Participation in this study is completely voluntary. Please read the information below and ask questions about anything that you do not understand before deciding if you want to participate. A researcher listed below will be available to answer your questions.

RESEARCH TEAM* Researcher: Leora Gabay Department of Kinesiology 818.915.7577 [email protected]

Faculty Advisor: Dr. Shane Stecyk, PhD Department of Kinesiology 18111 Nordhoff St. Northridge, CA 91330- 8287 818.677.4738 [email protected]

PURPOSE OF STUDY The purpose of this research study is to evaluate the effects of a treadmill walk with a real time biofeedback system on gait outcomes in individuals with lower limb amputations.

SUBJECTS Inclusion Requirements You are eligible to participate in this study if the following are met: a) Between the ages of 18-65 years old b) Current prosthetic is comfortable and does not inhibit walking c) Ability to walk comfortable for a minimum of 15 minutes d) Ability to follow test and training procedures e) NO acute orthopedic injury f) NO major surgery within the last 6 months g) NO cardiorespiratory complications h) NO unbearable stump pain during exercise i) Must obtain a medical clearance

Time Commitment*

This study will involve approximately 7 weeks of your time (2 week of evaluations (1 pre- and 1 post-intervention) and 5 weeks of intervention). Total hours required over 7 week span will be approximately 22 hours.

PROCEDURES Once you meet the criteria, you will be randomly assigned to either the intervention group or the control group. Participants from both groups will participate in a 50-minute exercise session 3 times per week for 1 hour each session for a consecutive 5-week period at the Center of Achievement. The session will consist of a warm-up, treadmill walking and cool-down exercises.

Before and after the 5-week session, you will be tested on gait and balance: It will be 1 hour each for each section, gait and balance (pre and post intervention) for 4 hours total.

• For the gait test, you till walk on a 10-meter walkway for 3 times wearing reflective markerers. This test will last approxiamately 1 hour each time for 2 hours total.

Your initials here ____ signify your consent to be videotaped during the gait analysis.

• For the balance section, you will be asked to stand on a dynamic force plateform in order to collect balance data information. There will be three tests that will ask you to stand while the force plate shifts, stand uninterrupted or to voluntarily shift weight. There will be 30 collective trials that will compile the one hour of data collection. You will be attached by a safety harnass during testing for safety purposes. The test will take approxiamately 1 hour each time, 2 hours total. • Additionally, you will be asked to complete the SF-36, a health survery which helps the researchers to better understand your current view of exercise and health.

RISKS AND DISCOMFORTS The possible risks and/or discomforts associated with the procedures described in this study include: cardiovascular complications, fatigue, exhaustion, injury, muscle cramps, and falling. Physician clearance will be obtained to ensure that you do not have any health risks for participating in exercise programs. Frequent rest time will be given to you during training and testing. You will be advised to drink a plenty of water before exercise sessions to avoid dehydration. Additionally, a research assistant will be present at all times to monitor the participant in order to minimize any risks or injury.

In case of emergency, emergency medical service (911) will be contacted and you will be referred to your primary care physician at your own cost.

This study involves no more than minimal risk. There are no known harms or discomforts associated with this study beyond those encountered in normal daily life.

BENEFITS Subject Benefits The possible benefits you may experience from the procedures described in this study include improved gait patterns, flexibility, balance and proprioception and psychology benefits.

Benefits to Others or Society If there are positive outcomes to this study, it may further affirm the benefits or visual feedback gait training for the rehabilitation process of people with unilateral lower limb amputations.

ALTERNATIVES TO PARTICIPATION The only alternative to participation in this study is not to participate.

COMPENSATION, COSTS AND REIMBURSEMENT Compensation for Participation You will receive free gait and balance evaluations, free exercise intervention and free parking for the duration of the intervention.

Costs There is no cost to you for participation in this study except that of transportation to arrive to the location of testing (18111 Nordhoff Street, Northridge, CA 91330) except for parking, which will be provided for you at no cost.

WITHDRAWAL OR TERMINATION FROM THE STUDY AND CONSEQUENCES

You are free to withdraw from this study at any time. If you decide to withdraw from this study you should notify the research team immediately. The research team may also end your participation in this study if you do not follow instructions, miss scheduled visits, or if your safety and welfare are at risk.

CONFIDENTIALITY Subject Identifiable Data Any information that will be collected in this study will remain confidential and will be disclosed only with your written permission or if required by law. The cumulative results of this study will be published, but all participants' names will be replaced by numeric codes for confidentiality. All documentation/data will be also secured in a locked file cabinet located in the staff office at the Center of Achievement during the study along with on a computer safeguarded with a username and password.. After completing the

75 study, they will be stored up to three years in the same place and then will be destroyed. Only the primary researcher and supervising faculty will have access to the data and related files.

Data Storage Computerized data will be stored on a safeguarded computer and physical data will be stored in a locked cabinet in the main office. The graduate researcher, Leora Gabay, will have all documents locked in her desk. Only she and faculty advisor, Dr. Shane Stecyk will have access. Any computerized data will be safeguarded with a password and username, which only the graduate researcher and chair will possess.

Data Access The researcher(s) and faculty advisor named on the first page of this form will have access to your study records. Any information derived from this research project that personally identifies you will not be voluntarily released or disclosed without your separate consent, except as specifically required by law. Publications and/or presentations that result from this study will not include identifiable information about you.

Data Retention • The researchers intend to keep the research data until analysis of the information is completed. • The researchers intend to keep the research data for approximately 3 years and then it will be destroyed.

IF YOU HAVE QUESTIONS If you have any comments, concerns, or questions regarding the conduct of this research please contact the research team listed on the first page of this form.

If you have concerns or complaints about the research study, research team, or questions about your rights as a research participant, please contact Research and Sponsored Projects, 18111 Nordhoff Street, California State University, Northridge, Northridge, CA 91330-8232, or phone 818-677-2901.

VOLUNTARY PARTICIPATION STATEMENT You should not sign this form unless you have read it and been given a copy of it to keep. Participation in this study is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your relationship with California State University, Northridge. Your signature below indicates that you have read the information in this consent form and have had a chance to ask any questions that you have about the study.

I agree to participate in the study.

______Participant Signature Date ______Printed Name of Participant ______Researcher Signature Date ______Printed Name of Researcher

APPENDIX C

Client Information Sheet

Subject: ______

Date of Amputation: __ / __ / _____

Date of Acquisition of Prosthetic Leg: __ / __ / ____

Amount per day with prosthesis: ______

Type of Leg: ______

Affected side (circle one): R L

Type of Amputation (circle one): Transfemoral Transtibial

K Level (circle one): K0 K1 K2 K3 K4

Type of therapy? When? ______

______

Subject Information Sheet Participant #_____ Type of Amputation (circle): AK BK D.O.B.: ___ / ___ / _____ Leg of Amputation (circle): R L Gender (circle): M F

Date: ___ / ____ / ______Visit #1 (circle): Initial Final Other: ______GENERAL: LEFT RIGHT Body mass: _____ kg Leg length: ______mm Leg length: ______mm Height: _____ mm Knee width: ______mm Knee width: ______mm ASIS: ______mm Ankle width: ______mm Ankle width: ______mm (Initials of Person Completing Information: _____ )