Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

Study Overview
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Brief Summary
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The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.

Detailed Description
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Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians. The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations. The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members. Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI. The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care. The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.

Official Title
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Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

Conditions
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Brain Concussion

Intervention / Treatment
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* Behavioral: Virtual Neuromuscular/Dual-Task Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 years of age at the time of enrollment Mild TBI or concussion diagnosis by a physician Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019) Access to a smartphone for app download Exclusion Criteria: Moderate or severe TBI Pre-injury neurological disorder Abnormal brain imaging findings (if performed as a part of routine care) Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Neuromuscular/Dual-Task Training<br>The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks. | Behavioral: Virtual Neuromuscular/Dual-Task Training<br>* The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.<br>|
| No Intervention: Standard-of-care<br>Participants will be provided routine instructions related to physical activity and rehabilitation exercises | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury rate | Acute musculoskeletal injury rate | 3 months after mTBI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention adherence | Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions | Upon enrollment and for the subsequent 8 weeks | 
| Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference | Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test | 
| Sleep quality | Participants will complete the Pittsburgh Sleep Quality Inventory | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test | 
| Dizziness | Participants will complete the Dizziness Handicap Inventory | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test | 
| Anxiety | Participants will complete the General Anxiety Disorder - 7 scale | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test | 
| Single/dual-task standing and gait | Participants will perform walking trials under single and dual-task conditions | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |