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

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Conditions

Gait

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.

Official Title

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

Quick Facts

Study Start:2019-01-01
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04047030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-60 years of age
  2. 2. Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.
  1. 1. Gustilo type IIIB or IIIC injuries
  2. 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. 3. Neurologic impairment or deficit that impairs gait
  4. 4. Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
  5. 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. 6. Unable to provide informed consent in English or Spanish.

Contacts and Locations

Principal Investigator

Stephen Sims, MD
PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Lisa Reider, PhD
PRINCIPAL_INVESTIGATOR
JHSPH/METRC

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
Barnes Jewish Hospital
St Louis, Missouri, 63110
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Carolinas Medical Center
Charlotte, North Carolina, 28204
United States
Womack Army Medical Center at Ft. Bragg
Fort Bragg, North Carolina, 28100
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Texas Health Science Center - Houston
Houston, Texas, 77030
United States
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

  • Stephen Sims, MD, PRINCIPAL_INVESTIGATOR, Carolinas Medical Center
  • Lisa Reider, PhD, PRINCIPAL_INVESTIGATOR, JHSPH/METRC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-01
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2019-01-01
Study Completion Date2024-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Gait