Status:
RECRUITING
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Lead Sponsor:
VA Office of Research and Development
Conditions:
Transtibial Amputation
Transfemoral Amputation
Eligibility:
All Genders
18-65 years
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 primar...
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 withi...
Eligibility Criteria
Inclusion
- 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
- Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Key Trial Info
Start Date :
January 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05989243
Start Date
January 31 2022
End Date
March 31 2026
Last Update
June 6 2025
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211