Tele-Rehabilitation for Recovery from Mild Traumatic Brain Injury
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
This study is testing a smartphone-based rehab program to see if it helps military members and young adults recover better from concussions compared to regular care.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05594225 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and effectiveness of a smartphone-based virtual Neuromuscular/Dual-Task intervention for military service members and active young adults recovering from a recent concussion. The study will assess baseline neuromuscular performance and compare it between military personnel and civilians, while also examining the impact of the intervention on reducing musculoskeletal injuries and improving performance in dual-task scenarios. Participants will be randomized to receive either the virtual intervention or standard care within three weeks of their mild traumatic brain injury.
Who should consider this trial
Good fit: Ideal candidates are active-duty military service members and physically active young adults aged 18-40 who have recently been diagnosed with a mild traumatic brain injury.
Not a fit: Patients with moderate or severe traumatic brain injuries or those with pre-existing neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance recovery outcomes and reduce the risk of further injuries for individuals with mild traumatic brain injuries.
How similar studies have performed: Other studies have shown promise in using virtual rehabilitation approaches for injury recovery, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David R Howell, PhD — University of Colorado School of Medicine
- Study coordinator: Makenna Hemmerle, MS
- Email: ConcussionResearch@CUAnschutz.edu
- Phone: 702-777-1502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.