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

Phase 1

Recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Virtual Neuromuscular/Dual-Task Training	Virtual Neuromuscular/Dual-Task Training	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.

Primary Outcome Measures

Name	Time	Method
Injury rate	3 months after mTBI	Acute musculoskeletal injury rate

Secondary Outcome Measures

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

Locations (2): University of Colorado Denver
🇺🇸
Aurora, Colorado, United States
Brooke Army Medical Center
🇺🇸
Fort Sam Houston, Texas, United States