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

Phase 1

Active, not recruiting

• Conditions: Brain Concussion

• Registration Number: NCT05594225
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Study Start: 2023-08-23
• Primary Completion: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-23
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States