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

NCT04047030 | Completed

• 1 other identifier: W81XWH-18-1-0815
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Gait

Outcome Measures

Primary Outcomes (7)

• Ease of use of the Mobility Toolkit during clinic

  Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.

  12 months

• Satisfaction of the Mobility Toolkit

  Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.

  12 months

• Gait Quality assessed with Mobility Tooklkit

  Gait Quality will be measured using the MTK to assess gait parameters such as lift acceleration, step time asymmetry, and peak-to-peak upper body pitch and roll.

  12 months

• Gait Quality assessed by performance tests

  Gait will be assessed while completing three performance tests: 10 meter walk, sit to stand, and timed up and go (TUG) Injured participants will be assessed at time of first weight bearing, and at clinic visits 3, 6 and 12 months following definitive treatment.

  Change in gate from measured at 3, 6 & 12 months

• Physical Function

  Patient Reported Function will be assessed using the physical function item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.

  Change in physical function measured at 3, 6, & 12 months

• Pain Score

  Patient Reported Pain will be assessed using the pain interference item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.

  Change in pain score measured at 3, 6, & 12 months

• Number of patient complications resulting from injury

  Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.

  12 months

Study Arms (2)

Injured Cohort

Approximately 300 participants treated for a fracture of the tibial plateau, pilon, ankle or calcaneus will be enrolled from METRC civilian trauma centers and military treatment facilities over an 18 month period. Participating centers treat large numbers of severe orthopaedic injuries and have a proven track record for successfully recruiting and retaining participants in prospective studies in orthopaedic trauma. Participants will be enrolled following definitive treatment of their injury.

Other: None- Observational Study

Non-Injured Volunteers

Non-injured adults of similar age and gender distribution will be enrolled at two participating centers (Carolinas Medical Center and Womack Military Medical Center). The sample of non-injured volunteers will exclude individuals with history of lower extremity injury, vascular disease, or who require use of ambulatory aides to walk.

Other: None- Observational Study

Interventions

None- Observational Study OTHER

No Intervention

Injured Cohort; Non-Injured Volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years of age
• Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.

You may not qualify if:

• Gustilo type IIIB or IIIC injuries
• 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).
• Neurologic impairment or deficit that impairs gait
• Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
• 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).
• Unable to provide informed consent in English or Spanish.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (10)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Womack Army Medical Center at Ft. Bragg

Fort Bragg, North Carolina, 28100, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

San Antonio Military Medical Center (SAMMC)

San Antonio, Texas, 78234, United States

Location

Study Officials

• Stephen Sims, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

• Lisa Reider, PhD

  JHSPH/METRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 6, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: August 31, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (10)