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New brace and rehab combo aims to get people with leg injuries back on their feet

NCT ID NCT05780502

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a custom energy-storing leg brace, combined with a high-intensity rehabilitation program, can improve walking, stair climbing, and daily function in people with lower leg injuries. About 370 adults who have been fitted with the brace will be followed before, during, and after the program. The goal is to see if this approach helps them move better and feel more capable in everyday life.

What this could mean

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

Active substance
Passive Dynamic Brace (custom leg brace) plus rehabilitation program
What this could lead to
If it works, this could provide a proven way to help people with leg injuries walk better, climb stairs, and return to daily activities.
What could go wrong
This is an early-stage study with no control group, so improvements may be due to natural recovery or other factors. The brace and rehab are intensive and may not work for everyone.

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.

Participants

About 370 people

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

Started

May 2015

Expected to finish

Dec 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.

Who is studied

The target population for this study will be those patients who have sustained a musculoskeletal injury and have been referred to be fitted for CUSTOMIZED EXOSKELETAL ORTHOSIS and RTR clinical pathway.

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: * Minimum 18 years of age * Fitted with a customized exoskeletal orthosis device * Able to provide written informed consent Exclusion Criteria: * Less than 18 years of age * Self-reported pregnancy * Not fitted with a customized exoskeletal orthosis * Unable or unwilling to provide written informed consent

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Musculoskeletal injury

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

  • Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

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