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Can a prosthetic foot that adapts its stiffness help amputees keep their balance?

NCT ID NCT07791433

Disease control Sponsor: Seattle Institute for Biomedical and Clinical Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a prosthetic foot that automatically changes its stiffness based on activity can improve balance for people with below-knee amputations. Participants will wear both their standard prescribed prosthesis and the automatic one while doing everyday activities like walking at different speeds, turning, and navigating ramps and uneven ground. The study measures balance control and self-reported mobility to see if the smart prosthesis offers an advantage.

What this could mean

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

Active substance
A novel prosthetic foot that automatically adjusts its stiffness based on the user's activity, compared to a standard fixed-stiffness prosthesis.
What this could lead to
If it works, this could lead to better balance and mobility for people with below-knee amputations, reducing fall risk in daily life.
What could go wrong
This is a small early-stage trial with only 20 participants, so results may not apply to everyone. The automatic prosthesis may not outperform the standard one in real-world conditions.

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 20 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 79 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: * Unilateral transtibial (below-knee) amputation * Been fit with a prosthesis and used it for at least 6 months * Wear the prosthesis for 4 or more hours on average per day * Be at least one-year post-amputation * Able to walk on a treadmill Exclusion Criteria: * Presence of disorder, pain, or injury other than amputation that interferes with gait * Current skin irritation or injury on residual limb * Use of an assistive device for walking (cane, walker, etc.)

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As listed by the trial registrant

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

Lower limb amputation below knee

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

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108, United States

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