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

NCT05594225 | Active Not Recruiting Phase 1

• 1 other identifier: 22-1352
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

• Injury rate

  Acute musculoskeletal injury rate

  3 months after mTBI

Secondary Outcomes (6)

• Intervention adherence

  Upon enrollment and for the subsequent 8 weeks

• 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

• Sleep quality

  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

Study Arms (2)

Virtual Neuromuscular/Dual-Task Training

EXPERIMENTAL

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

Standard-of-care

NO INTERVENTION

Participants will be provided routine instructions related to physical activity and rehabilitation exercises

Interventions

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.

Virtual Neuromuscular/Dual-Task Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Binghamton University: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• David R Howell, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: August 23, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)