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

Recruiting now · Not applicable

Conditions studied: Amputation

In brief

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.

Key facts

Study ID

NCT07266077

Run by

VA Office of Research and Development

People needed

30

Starts

2026-07-01

Expected to finish

2029-08-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• US military Veterans willing to travel to the Minneapolis VA Health Care System
• Unilateral, below-knee amputation
• Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)
• Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)
• Well-fitting and well-aligned prosthesis
• Uses a prescribed energy storage and return foot (ESAR)
• Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment)
• Access to computer, tablet, or smartphone and internet for video conferencing and REDCap data collection

You may not qualify if…

• Residual-limb skin problems
• Not a regular prosthesis user
• Mass over 125 kg (275 lbs)
• Residual limb too long to accommodate the study feet (104 mm of build height)
• Has used a hydraulic foot previously as part of clinical care or a research study
• Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
• Baseline PROMIS-APSRA or PROMIS-SSRA scores at the maximum levels (no room for improvement on primary outcomes)

Where it is running

• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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