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New powered knee aims to help amputees walk farther and more easily

NCT ID NCT07613502

Symptom relief Sponsor: University of Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Updated 3 times

Summary

This study will compare a new powered prosthetic knee called the Bio-Leg to the current standard C-Leg in 12 adults who have lost a leg above the knee. Participants will use their own C-Leg first, then switch to the Bio-Leg for 4-6 weeks. Researchers will measure how far they can walk in 6 minutes, how evenly they stand up, and how much energy they use while walking. The goal is to see if the Bio-Leg improves mobility and quality of life.

What this could mean

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

Active substance
Bio-Leg powered prosthetic knee (device)
What this could lead to
If it works, this could show that the Bio-Leg helps people with above-knee amputations walk farther, more evenly, and with less effort than the current standard C-Leg.
What could go wrong
This is a very small early study with only 12 participants, so results may not apply to everyone. The Bio-Leg may not prove better than the C-Leg, and participants could face discomfort or fitting issues.

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 12 people

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

Started

Jun 2026

Expected to finish

Jul 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

40 to 70 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: * Adults 40 to 70 years of age * Unilateral transfemoral amputation \> 1 year * K3 or K4 ambulator (based on the K classification system) and able to walk with no greater assistances than a single point cane * Current microprocessor-controlled prosthesis (C-leg) user with \> 6 months experience and able to walk without a device of using a single point cane * Able to give informed consent Exclusion Criteria: * Severe cardiovascular condition or other disease limiting study participation * Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities * Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation * Pain that limits walking of participation in walking activities * Current participation in rehabilitation to address walking function

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As listed by the trial registrant

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

Amputation Amputation of lower limb above knee Amputee

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

  • Brooks Rehabilitation

    RECRUITING

    Jacksonville, Florida, 32216, United States

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