NCT05320822 A Pragmatic Rehabilitation Intervention: The Active Rehab Study
| NCT ID | NCT05320822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Concussion, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-09 |
Trial Parameters
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Brief Summary
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.
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 in