Actively Recruiting
A Pragmatic Rehabilitation Intervention to Supplement Progressive Return to Activity Following Mild Traumatic Brain Injury in Service Members (SMs): The Active Rehab Study
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-27
130
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a new active rehabilitation program can improve recovery outcomes for soldiers who have experienced mild traumatic brain injury (mTBI), also known as concussion. The study aims to test if this active rehab approach helps soldiers return to duty faster and improves their cognitive and physical function. The research is conducted in a military setting and involves comparing current standard care with the new active rehab method. The study involves two groups of soldiers stationed at Fort Bragg, North Carolina, who have had an mTBI within the past two weeks. One group receives the current progressive return to activity (PRA) care, while the other group follows the Active Rehab protocol, which includes personalized activities such as low-intensity aerobic exercise, cognitive tasks, balance training, and visual/vestibular exercises. This rehab is progressed based on symptoms and duty needs over five phases, aiming to accelerate safe recovery. The intervention is delivered by trained providers, and outcomes from both groups are compared. Participants will be assessed at initial intake, two weeks post-enrollment, when asymptomatic, and upon clearance to return to full duty. Evaluations include military performance, heart rate variability, cognitive tests, coordination, symptom inventories, and quality of life measures. The study will follow participants for up to about a year to track recovery progress. Data collected will help develop a clinical algorithm to guide future active rehab for military personnel after mTBI.
CONDITIONS
Brief Title
A Pragmatic Rehabilitation Intervention: The Active Rehab Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current active duty military personnel stationed at Fort Bragg, North Carolina
- Available for recruitment within 2 weeks of mild traumatic brain injury (mTBI) injury date as indicated in medical record
- Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed via medical record
You will not qualify if you...
- Third mTBI/concussion in the past 12 months as indicated by medical record and/or participant self-report
- Symptoms clear at rest and exertion within 48 hours as indicated in medical record or during study enrollment
- Moderate to severe traumatic brain injury or TBI not meeting criteria for mild TBI 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 or medical record
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 2 weeks after mild traumatic brain injury
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to approximately 360 days or until return to duty clearance
Participants follow either the current Progressive Return to Activity protocol or the Active Rehab protocol. The Active Rehab protocol includes symptom-guided, progressive integration of activities such as low-intensity aerobic exercise, cognitive, balance, visual/vestibular, and general well-being activities. Participants progress through phases aiming for symptom stabilization and full return to duty.
Initial post-injury intake, 2-week post-enrollment visit (as possible), asymptomatic visit, and clearance to return to duty visit
Duration - Up to approximately 346 days after intervention initiation
Participants are monitored for recovery outcomes including military performance, physiological, clinical, and psychological health status through assessments following treatment completion.
Several follow-up assessments occurring after treatment completion
Trial Site Locations
Total: 2 locations
1
United States Special Operations Command
Fort Liberty, North Carolina, United States, 28310
Actively Recruiting
2
Womack Army Medical Center
Fort Liberty, North Carolina, United States, 28310
Actively Recruiting
Research Team
J
Johna K Register-Mihalik, PhD
P
Paula Gildner, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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