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A Pragmatic Rehabilitation Intervention: The Active Rehab Study

University of North Carolina, Chapel Hill · with United States Department of Defense · NCT05320822

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–99 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
130
US sites recruiting
2
Study start
June 4, 2024
Record last updated
February 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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). 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.

Being studied: Active Rehab (Group 2); Progressive Return to Activity (Group 1)

Conditions: Concussion, Brain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 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.

Recruiting US locations

  • United States Special Operations Command

    Fort Liberty, NC 28310

    Site contact: Stephen DeLellis, PA-C · 910-580-4021 · sdelellis@genevausa.org

  • Womack Army Medical Center

    Fort Liberty, NC 28310

    Site contact: Courtney Jones, PT, DPT, OCS · 910-907-8258 · courtney.v.jones8.mil@health.mil

Study contacts (from the official record)

  • Johna K Register-Mihalik, PhD · 919-962-2702 · johnakay@email.unc.edu
  • Paula Gildner, MPH · 919-966-0465 · pgildner@unc.edu
All healthy volunteers studies in North Carolina →
A Pragmatic Rehabilitation Intervention: The Active Rehab Study (NCT05320822) | Bored Studies