Actively Recruiting
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Led by VA Office of Research and Development · Updated on 2026-04-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how different prosthetic socket designs affect Veterans with lower limb amputations, focusing on those with transtibial and transfemoral amputations. The study aims to compare an adjustable Quatro socket to a conventional rigid socket to see which design might better improve rehabilitation, comfort, and function. This observational study involves 40 Veterans, equally divided by amputation type and gender, to better understand biomechanical and satisfaction differences. Participants will use both their own conventional prosthetic socket and an adjustable Quatro socket. They will walk on a force-measuring treadmill at various speeds ranging from 0.75 to 1.5 meters per second for about 60 seconds each speed while wearing each socket. After walking, they will complete questionnaires to evaluate their comfort and satisfaction with each socket. The study includes 20 Veterans with transtibial amputation and 20 with transfemoral amputation, with equal numbers of males and females in each group. During the study, researchers will assess biomechanical asymmetry and socket pistoning, which refers to residual limb movement within the socket, to understand how each socket affects walking stability and comfort. These assessments and questionnaires will be conducted over an average of four years. Participants are expected to be at least six months post-amputation with no current problems with their prosthesis or residual limb. This long-term monitoring helps evaluate the overall impact of socket design on rehabilitation and function.
CONDITIONS
Brief Title
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans aged 18 to 65 years
- Unilateral transtibial or transfemoral amputation
- At or above a K2 Medicare Functional Classification Level (ability to walk with limited community ambulation)
- At least 6 months post-amputation
- No current problems with prosthesis or residual limb
You will not qualify if you...
- Cardiovascular, pulmonary, or neurological disease or disorder
- Requirement for an assistive device for the unaffected leg, such as an orthosis or cane
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated assessments through study completion, an average of 4 years
Participants use two different prosthetic socket designs, walking on a force-measuring treadmill at various speeds and completing evaluations for each socket.
Visits occur for each socket evaluation; exact number varies depending on participant schedule
Duration - Through study completion, an average of 4 years
Participants are observed over time to assess biomechanical asymmetry, socket pistoning, and satisfaction with prosthetic sockets.
Ongoing assessments during follow-up visits
Trial Site Locations
Total: 1 location
1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Actively Recruiting
Research Team
A
Alena Grabowski, PhD BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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