Active rehabilitation for soldiers with mild traumatic brain injury

A Pragmatic Rehabilitation Intervention to Supplement Progressive Return to Activity Following Mild Traumatic Brain Injury in Service Members (SMs): The Active Rehab Study

This study tests if a new active rehabilitation program can help soldiers recover faster and perform better after a mild traumatic brain injury compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 2 sites (Fort Liberty, North Carolina and 1 other locations)
• Trial ID: NCT05320822 on ClinicalTrials.gov

What this trial studies

This research examines the effectiveness of an active rehabilitation intervention for soldiers recovering from mild traumatic brain injury (mTBI). The study involves a quasi-experimental design where participants are divided into two groups: one receiving standard care and the other undergoing the Active Rehab protocol. Soldiers will be assessed on various outcomes, including military performance and cognitive health, over two nine-month periods. The goal is to determine if the Active Rehab approach can accelerate recovery and improve overall outcomes compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are active duty military personnel stationed at Fort Bragg who have sustained a mild traumatic brain injury within the last two weeks.

Not a fit: Patients who have experienced multiple concussions or have symptoms that resolve quickly may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance recovery times and functional outcomes for soldiers with mTBI.

How similar studies have performed: Other studies have shown promise in using active rehabilitation approaches for mTBI, but this specific intervention is novel in its military application.

Eligibility criteria

Inclusion Criteria:

* Current active duty military personnel stationed at Fort Bragg, North Carolina.
* Report to clinic/provider at Fort Bragg and available for recruitment within 2 weeks of mTBI injury date as indicated in medical record.
* Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed via medical record.

Exclusion Criteria:

* Third mTBI/concussion in the past 12 months as indicated by the medical record and/or participant self-report.
* Symptoms clear at rest and exertion within 48 hours as indicated in medical record and or during study enrollment process.
* Moderate-Severe TBI, or TBI not meeting the criteria for mTBI as indicated by provider diagnosis.
* Polytrauma or other injuries preventing completion of initial study assessments in the 2-week window as indicated in initial screening/medical record.

TBI, per the funding opportunity announcement is defined as: "being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain." For the proposed study, only those meeting the VA/Department of Defense severity criteria of mild (normal structural imaging, loss of consciousness 0-30 minutes, alteration of consciousness or mental state up to 24 hours, posttraumatic amnesia up to 24 hours, and Glasgow Coma Scale of 13-15) will be targeted.

Where this trial is running

Fort Liberty, North Carolina and 1 other locations

• United States Special Operations Command — Fort Liberty, North Carolina, United States (RECRUITING)
• Womack Army Medical Center — Fort Liberty, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Johna K Register-Mihalik, PhD — University of North Carolina, Chapel Hill
• Study coordinator: Johna K Register-Mihalik, PhD

Conditions: Concussion, Brain, Concussion, Rehabilitation