NCT05320822 · University of North Carolina, Chapel Hill
A Pragmatic Rehabilitation Intervention: The Active Rehab Study
(ARM)
What this study is about
The strategic objective of this research line is to examine improving short- and long-term outcomes for soldiers following mild traumatic brain injury (mTBI).
View original scientific description
The strategic objective of this research line is to examine improving short- and long-term outcomes for soldiers following mild traumatic brain injury (mTBI). The technical objectives are to: 1) conduct a Phase 1 quasi-experimental pragmatic trial testing the potential benefit of provider directed active rehabilitation therapies ("Active Rehab") in accelerating return of injured soldiers back to active duty and improving cognitive and functional limitations following mTBI, and 2) operationalize and disseminate a clinical active rehabilitation algorithm for use in military settings. The central hypothesis is that an active rehabilitation algorithm in the context of the progressive return to activity will improve clinical and functional outcomes, including time to return to duty. The Active Rehab intervention expands on progressive return to activity guidelines by providing activities that can be completed and progressed during Stage 1 of the progressive return to activity protocol, when the participant is at least 24 hours postinjury. Active Rehab includes an adaptive paradigm based on personal characteristics, symptom presentation, and duty requirements that integrate with current progressive return to activity guidelines. Activity progressions consider the initial presentation and changes in participant status during treatment, with the goal of safely accelerating recovery. Severity and presence of symptoms will guide progression: worse, same or better as reported by the participant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Fort Liberty, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations