Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
- Conditions
- Transtibial AmputationTransfemoral Amputation
- Interventions
- Device: Conventional prosthetic socketDevice: Adjustable Quatro socket
- Registration Number
- NCT05989243
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
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
- Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Veterans with a transfemoral amputation Conventional prosthetic socket 20 Veterans with a transfemoral amputation, 10 females and 10 males Veterans with a transfemoral amputation Adjustable Quatro socket 20 Veterans with a transfemoral amputation, 10 females and 10 males Veterans with a transtibial amputation Conventional prosthetic socket 20 Veterans with a transtibial amputation, 10 females and 10 males Veterans with a transtibial amputation Adjustable Quatro socket 20 Veterans with a transtibial amputation, 10 females and 10 males
- Primary Outcome Measures
Name Time Method Prosthetic Evaluation Questionnaire through study completion, an average of 4 years 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. The investigators will compare overall and domain-specific scores between groups and sockets.
Biomechanical Asymmetry through study completion, an average of 4 years 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. The investigators will compare asymmetry between groups and sockets.
- Secondary Outcome Measures
Name Time Method Socket pistoning through study completion, an average of 4 years Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets.
Trial Locations
- Locations (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
🇺🇸Aurora, Colorado, United States