Condition: Concussion, Brain · Sponsor: University of North Carolina, Chapel Hill
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 pa…
This description comes directly from the study's public registry record.
Johna K Register-Mihalik, PhD · 919-962-2702 · johnakay@email.unc.edu
Paula Gildner, MPH · 919-966-0465 · pgildner@unc.edu
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| United States Special Operations Command | Fort Liberty, North Carolina, United States | Recruiting |
| Womack Army Medical Center | Fort Liberty, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05320822