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

Gait Clinical Trial

— MBTK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047030
• Other study ID #: W81XWH-18-1-0815
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Major Extremity Trauma Research Consortium
• Contact: Elizabeth Wysocki, MS
• Phone: 4109550396
• Email: ewysock2[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 31, 2024
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait

Intervention

Other:
• None- Observational Study
No Intervention

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina
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	Carolinas Medical Center	Charlotte	North Carolina
United States	Womack Army Medical Center at Ft. Bragg	Fort Bragg	North Carolina
United States	University of Texas Health Science Center - Houston	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	San Antonio Military Medical Center (SAMMC)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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