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New training aims to fix uneven walking in leg prosthesis users

NCT ID NCT05695911

Knowledge-focused Sponsor: University of Colorado, Denver 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a 40-week biofeedback training program can help people with a leg prosthesis (attached directly to the bone) walk with more equal weight on both legs. Fifteen participants will either receive the training or standard education. Researchers will measure feasibility, balance, and daily activity to see if the approach is worth testing in larger trials.

What this could mean

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

Active substance
limb-load biofeedback training
What this could lead to
If successful, this could point toward a standard training method to help people with leg prostheses walk more symmetrically and reduce long-term joint problems.
What could go wrong
This is a very small, early feasibility study with only 15 expected completers. The training is behavioral, so results may vary widely and may not apply to all amputees.

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 25 people

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

Started

Jan 2023

Expected to finish

Jan 2027

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 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: * Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes * ≥ 18 years old * History of severe socket-related skin or residual limb problems * Schedule for OI prosthesis implantation surgery Exclusion Criteria: * Vascular amputation etiology * Substance abuse * Unstable heart condition * Acute systemic infection * Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24) * Active cancer treatment

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As listed by the trial registrant

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

Amputation Osseointegration Transfemoral amputation

Contacts and locations

Locations

  • CU Physical Therapy

    Aurora, Colorado, 80045, United States

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