Status:
RECRUITING
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
VA Puget Sound Health Care System
Minneapolis Veterans Affairs Medical Center
Conditions:
Amputation
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veteran...
Detailed Description
Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and people with limb loss suffer from a wide range of mobility lim...
Eligibility Criteria
Inclusion Criteria:
- has a unilateral (one leg) transtibial (below-knee) amputation
- has used a prosthetic limb for walking for at least six months
- has a comfortably fitting prosthetic socket
- has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet
- be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
Exclusion Criteria:
- contralateral limb or upper limb amputation that would interfere with completion of study activities
- are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)
- unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress
- current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness)
- weight greater than 263lbs.
- inadequate cognitive or language function to consent to participate
- currently incarcerated
- impaired decision-making ability or the use of a legally authorized representative
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05473065
Start Date
March 1 2024
End Date
July 31 2026
Last Update
September 8 2025
Active Locations (2)
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1
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
2
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108