Clinical Trial

Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations

Recruiting
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Summary
Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-31
Trial Details
NCT Number NCT07266077
Lead Sponsor VA Office of Research and Development
Collaborators: University of Washington
Conditions Amputation
Enrollment 30 participants
Start Date 2026-07-01
Primary Completion 2029-08-01 (estimated)
Study Completion 2029-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30