ClinConnect ClinConnect Logo
Search / Trial NCT04047030

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

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Aug 5, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Mobility Toolkit clinical trial is studying how well patients recover their ability to walk after having surgery for injuries to the lower part of their legs, like fractures in the ankle or other related bones. The researchers are looking to enroll 300 participants between the ages of 18 and 60 who have had these types of surgeries. If you have a fracture that required surgical treatment and meet the age requirement, you might be eligible to join.

Participants in this study will be monitored to see how their walking improves over time. The trial is seeking individuals who are generally healthy aside from their recent lower-leg injuries. However, those with certain severe injuries, significant neurological issues, or other conditions that could affect their ability to walk may not qualify. Joining this study could help improve future treatments for similar injuries, and participants will have the chance to contribute to important research while receiving care for their recovery.

Gender

ALL

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.

About Major Extremity Trauma Research Consortium

The Major Extremity Trauma Research Consortium (METRC) is a collaborative network dedicated to advancing the understanding and treatment of severe extremity injuries. Comprising leading trauma centers, researchers, and clinical experts, METRC focuses on conducting high-quality clinical trials that aim to improve patient outcomes through innovative therapies and rehabilitation strategies. By fostering multidisciplinary partnerships and utilizing cutting-edge methodologies, METRC strives to generate robust evidence that informs best practices in the management of extremity trauma, ultimately enhancing the quality of care for affected individuals.

Locations

Lexington, Kentucky, United States

Nashville, Tennessee, United States

Asheville, North Carolina, United States

Lexington, Kentucky, United States

Bethesda, Maryland, United States

Charlotte, North Carolina, United States

Saint Louis, Missouri, United States

Houston, Texas, United States

Baltimore, Maryland, United States

San Antonio, Texas, United States

Fort Bragg, North Carolina, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Stephen Sims, MD

Principal Investigator

Carolinas Medical Center

Lisa Reider, PhD

Principal Investigator

JHSPH/METRC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials