Slope Adaptive Foot to help veterans with below-knee amputation participate more in daily life
Official title: Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
Run by VA Office of Research and Development · NCT07266077 · Data updated 2026-11-12
Tests a new slope-adaptive foot to see if it helps veterans with below-knee amputation walk more comfortably and participate in activities, compared with a standard hydraulic foot.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | August 1, 2029 |
| Study ends | August 1, 2029 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07266077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are US military veterans with a single below-knee amputation who have used a prosthesis for at least 12 months and are classified as K3 level.
✕Probably not a fit
Patients who do not experience improved participation or who have conditions limiting mobility may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares two prosthetic foot options in veterans with unilateral below-knee amputation. It uses a cross-over randomized design to have participants try the slope adaptive foot and a typical hydraulic foot, with mixed-methods to measure participation and fall-related health over time. The goal is to determine which foot best supports long-term participation in daily and recreational activities. Longitudinal data collection will include functional measures and participant experiences. The research is conducted at the Minneapolis VA Health Care System with collaboration from the University of Washington.
Why it matters
Potential benefit: If successful, veterans may experience improved participation in daily activities and reduced fall risk with the slope-adaptive foot.
How similar studies have gone: Pilot testing has shown favorable feedback for the slope-adaptive foot, suggesting potential benefits, but comprehensive comparative data are needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Sara Koehler-McNicholas, PhD MS BS — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Sara Koehler-McNicholas, PhD MS BS
- Email: sara.koehler@va.gov
- Phone: (612) 467-4017
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.
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Evaluation of a new myoelectric prosthesis for transradial amputees
This study is testing a new type of prosthetic arm that uses a special implant to help people with below-the-elbow amputations control it more easily and naturally.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.