Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Brain Concussion
- Sponsor
- University of Colorado, Denver
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Injury rate
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Injury rate
Time Frame: 3 months after mTBI
Acute musculoskeletal injury rate
Secondary Outcomes
- Intervention adherence(Upon enrollment and for the subsequent 8 weeks)
- Sleep quality(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Single/dual-task standing and gait(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- 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)
- Dizziness(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Anxiety(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)