A Pragmatic Rehabilitation Intervention: The Active Rehab Study
Recruiting now · Not applicable
Conditions studied: Concussion, Brain
In brief
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.
Key facts
- Study ID
- NCT05320822
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 130
- Starts
- 2024-06-04
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- United States Special Operations Command — Fort Liberty, North Carolina, United States (enrolling)
- Womack Army Medical Center — Fort Liberty, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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