Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Study Overview
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Brief Summary
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The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Detailed Description
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The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Official Title
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Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation

Conditions
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Transtibial Amputation, Transfemoral Amputation

Intervention / Treatment
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* Device: Conventional prosthetic socket
* Device: Adjustable Quatro socket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The investigators will enroll up to 40 Veterans 20 with unilateral transtibial amputation 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator Exclusion Criteria: Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Veterans with a transtibial amputation<br>20 Veterans with a transtibial amputation, 10 females and 10 males | Device: Conventional prosthetic socket<br>* Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for  60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.<br>Device: Adjustable Quatro socket<br>* Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for  60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.<br>|
| Veterans with a transfemoral amputation<br>20 Veterans with a transfemoral amputation, 10 females and 10 males | Device: Conventional prosthetic socket<br>* Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for  60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.<br>Device: Adjustable Quatro socket<br>* Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for  60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanical Asymmetry | The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. We will compare asymmetry between groups and sockets. | through study completion, an average of 4 years | 
| Prosthetic Evaluation Questionnaire | The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. We will compare overall and domain-specific scores between groups and sockets. | through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socket pistoning | Movement of the residual limb within the socket. We will compared socket pistoning between groups and sockets. | through study completion, an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomechanics, Kinematics, Walking, Prostheses