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Custom brace and therapy aim to get wounded warriors back on their feet

NCT ID NCT02158884

Disease control Sponsor: Major Extremity Trauma Research Consortium 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a custom-designed brace called the IDEO, combined with a physical therapy program called Return to Run, can improve physical function in people with traumatic leg injuries. Participants are adults aged 18 to 60 who are at least two years past a leg injury below the knee and have healed fractures. The goal is to see if this integrated approach helps with agility, strength, and daily activities.

What this could mean

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

Active substance
IDEO brace (Intrepid Dynamic Exoskeletal Orthosis) and Return to Run physical therapy program
What this could lead to
If successful, this approach could help people with leg injuries regain better mobility, agility, and quality of life, potentially allowing a return to active lifestyles.
What could go wrong
This is a relatively small study focused on military personnel, so results may not apply to everyone. The brace and therapy may not work for all types of leg injuries.

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

91 people

The number who actually took part.

Start date

Jun 2014

Finished

Apr 2018

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 60 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: 1. Ages 18-60 2. Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee 3. Healed fractures and able to fully weight bear 4. Evidence of either: * Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury (defined as less than 4 out of 5 on manual muscle test) * Limited ankle dorsiflexion (\< 10 degrees) and /or limited ankle plantarflexion (\< 20 degrees) resulting from leg injury * Mechanical pain with loading to hindfoot/midfoot (\>= 50 mm on a 0-100 mm visual analogue scale assessing average daily pain) * Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion * Candidate for amputation secondary to ankle/foot impairment Exclusion Criteria: 1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology. 2. Non-ambulatory 3. Surgery on study limb anticipated in next 6 months 4. Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia) 5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb 6. Unable or unwilling to participate in two 4-week PT programs 7. Pregnancy 8. Non-English speaking

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Conditions

The condition(s) this trial relates to.

injury Leg Injuries

As listed by the trial registrant

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

Leg injuries Trauma

Contacts and locations

Locations

  • Naval Medical Center San Diego

    San Diego, California, 92134, United States

  • San Antonio Center for the Intrepid

    San Antonio, Texas, 78234-4504, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.