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

Completed

• Conditions: Gait

• Registration Number: NCT04047030
• Lead Sponsor: Major Extremity Trauma Research Consortium

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.

Detailed 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. All participating centers will undergo training to implement the Mobility Toolkit (MTK). Research Staff will facilitate a series of performance tests while participants wear the MTK device. MTK assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. These individuals will be enrolled and assessed once at two participating centers. Study flow and data capture are summarized in the figure on the next page.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Primary Completion: 2023-12-01
• Study Completion: 2024-08-31
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patient complications resulting from injury	12 months	Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.
Gait Quality assessed with Mobility Tooklkit	12 months	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.
Ease of use of the Mobility Toolkit during clinic	12 months	Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Satisfaction of the Mobility Toolkit	12 months	Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.
Gait Quality assessed by performance tests	Change in gate from measured at 3, 6 & 12 months	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.
Physical Function	Change in physical function measured at 3, 6, & 12 months	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.
Pain Score	Change in pain score measured at 3, 6, & 12 months	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.

Trial Locations

Locations (10)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Maryland R Adams Cowley Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Barnes Jewish Hospital; 🇺🇸 St Louis, Missouri, United States

Mission Hospital; 🇺🇸 Asheville, North Carolina, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Womack Army Medical Center at Ft. Bragg; 🇺🇸 Fort Bragg, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Texas Health Science Center - Houston; 🇺🇸 Houston, Texas, United States

San Antonio Military Medical Center (SAMMC); 🇺🇸 San Antonio, Texas, United States