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

Major Extremity Trauma Research Consortium244 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

244

Conditions

Gait

Interventions

None- Observational StudyOTHER

No Intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.