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New smart foot could help veterans walk hills safely

NCT ID NCT07266077

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a new prosthetic foot called the Slope Adaptive Foot (SAF) that automatically adjusts to slopes and uneven ground. Thirty veterans with below-knee amputations will try both the SAF and a standard hydraulic foot to see which one improves their ability to take part in social activities and reduces fall-related fears. The goal is to help veterans move more confidently in daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Slope Adaptive Foot (SAF) prosthetic device
What this could lead to
If successful, this foot could help veterans with below-knee amputations walk more easily on slopes and uneven ground, boosting their confidence and participation in daily activities.
What could go wrong
This is a small early-stage trial with only 30 participants, so results may not apply to everyone. The device may not work better than current options, and individual experiences can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

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