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NCT Number: NCT05594225

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Neuromuscular/Dual-Task Training

Behavioral

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 outcomes

  1. Injury rate

    Time frame: 3 months after mTBI

    Acute musculoskeletal injury rate

Secondary outcomes

  1. Intervention adherence

    Time frame: Upon enrollment and for the subsequent 8 weeks

    Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions

  2. Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference

    Time frame: 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

  3. Sleep quality

    Time frame: 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

  4. Dizziness

    Time frame: 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

  5. Anxiety

    Time frame: 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

  6. Single/dual-task standing and gait

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Binghamton University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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