A Phase 1 interventional study of Virtual Neuromuscular/Dual-Task Training in Brain Concussion, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of Colorado, Denver · Phase 1, Interventional, and Treatment
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.
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.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's planned enrollment of 88 is above the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will be provided routine instructions related to physical activity and rehabilitation exercises
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.
Injury rate
Acute musculoskeletal injury rate
Time frame: 3 months after mTBI
Intervention adherence
Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Plan to share: Undecided — Unidentified/blinded IPD data may be made available upon reasonable request.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver