Assessing recovery after lower-leg injuries using a mobility toolkit

The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma

This study is testing a mobility toolkit to see how well it helps people aged 18-60 recover after surgery for lower-leg injuries compared to healthy adults.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Major Extremity Trauma Research Consortium (Academic / other)
• Locations: 10 sites (Lexington, Kentucky and 9 other locations)
• Trial ID: NCT04047030 on ClinicalTrials.gov

What this trial studies

This observational study will enroll 300 participants aged 18-60 who have undergone surgical treatment for lower-extremity articular injuries, such as fractures of the tibial plateau, pilon, ankle, and calcaneus. Participants will be assessed using the Mobility Toolkit (MTK), which includes performance tests while wearing the device. Additionally, 150 non-injured adults matched by age and gender will be assessed to provide a comparative baseline. The study aims to gather data on functional recovery following these injuries.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-60 who have sustained specific lower-extremity fractures requiring surgical fixation.

Not a fit: Patients with severe injuries, neurological impairments, or other conditions affecting gait may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of recovery patterns and improve rehabilitation strategies for patients with lower-extremity injuries.

How similar studies have performed: While similar approaches have been explored, this specific use of the Mobility Toolkit for assessing functional recovery in lower-extremity trauma is relatively novel.

Eligibility criteria

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.

Where this trial is running

Lexington, Kentucky and 9 other locations

• University of Kentucky — Lexington, Kentucky, United States (Recruiting)
• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (Not_yet_recruiting)
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Not_yet_recruiting)
• Barnes Jewish Hospital — Saint Louis, Missouri, United States (Not_yet_recruiting)
• Mission Hospital — Asheville, North Carolina, United States (Not_yet_recruiting)
• Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
• Womack Army Medical Center at Ft. Bragg — Fort Bragg, North Carolina, United States (Not_yet_recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
• University of Texas Health Science Center - Houston — Houston, Texas, United States (Not_yet_recruiting)
• San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Stephen Sims, MD — Carolinas Medical Center
• Study coordinator: Elizabeth Wysocki, MS

Conditions Gait