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New toolkit tracks walking recovery after leg breaks

NCT ID NCT04047030

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new 'Mobility Toolkit' to see how well it measures walking recovery in 244 adults aged 18-60 who had surgery for serious leg fractures. Participants used the toolkit during clinic visits over a year. The goal was to see if the toolkit is easy to use and accurately tracks improvements in walking and pain.

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

244 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 2024

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

Adults ages 18-60 surgically treated for a fracture of the tibial plateau, pilon, ankle, or calcaneus at one of 10 participating centers. Patients meeting the inclusion and exclusion criteria will approached for enrollment in to the study.

Ages

18 to 60 years

Sex

Anyone

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. 18-60 years of age 2. Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation. Exclusion Criteria: 1. Gustilo type IIIB or IIIC injuries 2. No other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures). 3. Neurologic impairment or deficit that impairs gait 4. Prior injuries or conditions that alter gait (e.g. severe osteoarthritis) 5. Severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders). 6. Unable to provide informed consent in English or Spanish.

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

GAIT

Contacts and locations

Locations

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • San Antonio Military Medical Center (SAMMC)

    San Antonio, Texas, 78234, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • University of Texas Health Science Center - Houston

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

  • Womack Army Medical Center at Ft. Bragg

    Fort Bragg, North Carolina, 28100, United States

More trials for these conditions

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