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

Study Overview
=================
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.

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

Conditions
-----------------
Gait

Intervention / Treatment
-----------------
* Other: None- Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years of age Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injured Cohort<br>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<br>* No Intervention<br>|
| Non-Injured Volunteers<br>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<br>* No Intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |