DESIGN AND DEVELOPMENT OF A SOFT PEDIATRIC SUPPORT GARMENT FOR ANKLE-FOOT ORTHOSES WEARERS by Danielle A Civil A thesis submitted to the Faculty of the University of Delaware in partial fulfillment of the requirements for Master of Science in Fashion and Apparel Studies Spring 2019 © 2019 Danielle Civil All Rights Reserved DESIGN AND DEVELOPMENT OF A SOFT PEDIATRIC SUPPORT GARMENT FOR ANKLE-FOOT ORTHOSES WEARERS by Danielle A Civil Approved: __________________________________________________________ Michele Lobo, PT, Ph.D. Professor in charge of thesis on behalf of the Advisory Committee Approved: __________________________________________________________ Huantian Cao, Ph.D. Interim Chair of the Department of Fashion and Apparel Studies Approved: __________________________________________________________ John Pelesko, Ph.D. Interim Dean of the College of Arts and Sciences Approved: __________________________________________________________ Douglas J. Doren, Ph.D. Interim Vice Provost for Graduate and Professional Education ACKNOWLEDGMENTS Throughout the course of this research and my master’s program, I have received an incredible amount of support, guidance, and assistance. I would first like to thank my advisor Dr. Michele Lobo whose guidance and expertise was incredibly invaluable. I am extremely appreciative of her support and encouragement throughout this process and so inspired by her passion and drive to help children. I’d also like to thank the rest of my committee, Dr. Huantian Cao and Dr. Karin Grävare Silbernagel, for their expertise and feedback that made my research stronger. Thank you so much to the Move To Learn lab team who has offered an incredible amount of support to me during the span of this research. Specifically, thank you to Andrea Cunha for your helpful contributions to the functional testing and data analysis; her expertise, hard work, and kindness was invaluable throughout the duration of this research. I’d also like to thank Joey Lanzona for his coding assistance. I was so lucky to work with three incredible families and children that inspired me each time I had the chance to visit them. The kindness and positivity that each participant and their families offered motivated this research, and without them, none of this could have been accomplished. Lastly, I’d like to thank my family and friends who offered so much love and support throughout the course of this research. Thank you for keeping me sane and motivated. iii TABLE OF CONTENTS LIST OF TABLES ........................................................................................................ vi LIST OF FIGURES ...................................................................................................... vii ABSTRACT ................................................................................................................ viii Chapter 1 INTRODUCTION .............................................................................................. 1 2 REVIEW OF LITERATURE AND BACKGROUND ...................................... 3 2.1 The Foot and Ankle ................................................................................... 3 2.2 Orthoses ..................................................................................................... 5 2.2.1 Ankle Foot Orthotics (AFOs) ........................................................ 6 2.2.1.1 Types of AFOs ............................................................... 7 2.2.1.1.1 Solid (Rigid AFOs) ...................................... 7 2.2.1.1.2 Hinged AFOs ............................................... 8 2.2.2 Orthotic Materials ......................................................................... 9 2.3 User Satisfaction with AFOs ................................................................... 10 2.4 Measuring AFO Effectiveness ................................................................ 11 2.4.1 How to Assess Patient Satisfaction with Orthotic Devices ......... 12 2.5 Commercially Available Ankle Support Devices ................................... 14 2.6 Design Theory ......................................................................................... 16 2.6.1 Medical Design ........................................................................... 16 2.6.1.1 Design Characteristics of an Ideal Orthotic Device ..... 16 2.6.2 Apparel Design Process .............................................................. 17 2.6.2.1 Functional Design Theory ............................................ 18 2.6.2.2 FEA Framework ........................................................... 18 3 DESIGN AND DEVELOPMENT OF A PEDIATRIC SUPPORT GARMENT: RESEARCH OBJECTIVES AND JUSTIFICATION ............... 20 iv 4 METHODS ...................................................................................................... 22 4.1 Participants .............................................................................................. 22 4.1.1 Participant Medical Conditions ................................................... 25 4.2 Procedure ................................................................................................. 27 4.3 Review of Users’ Wants and Needs ........................................................ 28 4.4 Design and Prototyping ........................................................................... 29 4.5 Prototype Testing .................................................................................... 30 4.5.1 Functional Measures ................................................................... 30 4.5.2 Perception of Device ................................................................... 35 4.5.3 Prototype Testing Metrics ........................................................... 35 5 RESULTS ........................................................................................................ 38 5.1 Summary of Users’ Wants and Needs .................................................... 38 5.2 Initial Patient Interviews ......................................................................... 44 5.3 Physical Therapy Characteristics ............................................................ 46 5.4 Design and Development of Prototypes .................................................. 47 5.5 Prototype Testing .................................................................................... 50 5.5.1 Gross Motor Performance ........................................................... 51 5.5.2 Gait analysis ................................................................................ 52 5.5.3 Metric Testing Outcomes ............................................................ 54 5.5.4 Perception Assessment ................................................................ 62 5.6 Follow Up Visit Wearing Times and Feedback Results ......................... 63 6 DISCUSSION .................................................................................................. 66 7 CONCLUSION ................................................................................................ 71 REFERENCES ............................................................................................................. 74 Appendix A SUPPLEMENTAL MATERIALS ................................................................... 82 A.1 Summary of Non-Orthotic Brace Attributes ........................................... 83 A.2 Clothing Design for Individuals With Special Clothing Needs – Fitting Interview Questions ..................................................................... 84 B UNIVERSITY OF DELAWARE’S IRB APPROVED RESEARCH ............. 86 v LIST OF TABLES Table 1: Materials Commonly Used for Fabricating Orthoses ............................... 9 Table 2: Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) ........................................................................................... 14 Table 3: Orthotics and Prosthetic Users’ Survey (CSD-OPUS). .......................... 14 Table 4: Prototype Testing Metrics ....................................................................... 36 Table 5: Summary of User Perception Coding ..................................................... 40 Table 6: Summary of User Satisfaction from Online Forums, Published Research, and In-person Interviews ......................................................................... 41 Table 7: Participants’ Characteristics of Body Function and Structure. ............... 46 Table 8: Gross Motor performance across the three conditions: barefoot, prototype and AFO (percentage). ............................................................................ 51 Table 9: Gait performance during three conditions: barefoot, prototype and AFO. ........................................................................................................ 53 Table 10: Flextion abilty for the initial contact phase during three conditions: barefoot, prototype and AFO. ................................................................. 54 Table 11: Prototype Testing Metrics Chart ............................................................. 57 Table 12: Perception of Assistive Device Questionnaire Results ........................... 63 Table 13: Average self-reported wearing frequency and duration throughout a 3- week testing period based on reports from the participant log. .............. 63 vi LIST OF FIGURES Figure 1: Diagram of Foot Anatomy (Betts et al., 2017) .......................................... 3 Figure 2: Diagram of Ideal Foot