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Smart knees may help amputees stay steady and active

NCT ID NCT06937242

Symptom relief Sponsor: Hanger Institute for Clinical Research and Education, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a prosthetic knee with a built-in computer (microprocessor-controlled) can help people with above-knee amputations have fewer fall-related problems, walk faster, and feel better overall. About 100 adults who already use a basic prosthetic knee will either keep their current knee or get a smart knee. Researchers will track falls, confidence, and quality of life over time.

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 100 people

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

Started

Jul 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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 transfemoral or knee disarticulation limb loss. * 6 months or longer since time of limb loss. * Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee. * Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months. * Clinician has deemed patient limited community ambulator (Medicare functional classification level K2). * In addition, Medicare functional classification level K2 as determined by at least one of the following criteria: 1. Houghton Score: 5-10 2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75. 3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months * Ability to read, write, and understand English. Exclusion Criteria: * Any health condition that would prevent safely completing trial activities. * Any individuals that weigh 275 lbs or more. * Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week * Individuals with a history of acute or chronic residual limb breakdown * Individuals with declining health status such that he/she subsequently reports reduced activity over the past 6 months

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Conditions

The condition(s) this trial relates to.

amelia of lower limb injury

As listed by the trial registrant

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

Amputation Amputation; traumatic, leg: thigh, between hip and knee Limb; absence, congenital, lower Lower limb amputation above knee Lower limb amputation above knee (injury) Prosthesis user

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

  • Hanger Inc.

    RECRUITING

    Austin, Texas, 78758, United States

More trials for these conditions

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