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A Pragmatic Rehabilitation Intervention: The Active Rehab Study

A Pragmatic Rehabilitation Intervention to Supplement Progressive Return to Activity Following Mild Traumatic Brain Injury in Service Members (SMs): The Active Rehab Study

Who can join

Ages 18 to 99 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• Active Rehab (Group 2) (other)
• Progressive Return to Activity (Group 1) (other)

Sponsor: University of North Carolina, Chapel Hill · Participants: 130 · Started: Jun 4, 2024

Contact the study team

• Johna K Register-Mihalik, PhD · Phone: 919-962-2702
• Paula Gildner, MPH · Phone: 919-966-0465

Official record on ClinicalTrials.gov — NCT05320822

Locations in the U.S.

Conditions

• Concussion

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.