Recruiting

Rehabilitation Intervention

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05320822

Conditions

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Active Rehab (Group 2)

Progressive Return to Activity (Group 1)

Study Details

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.

Conditions

Concussion, Brain

Study ID

NCT05320822

Start date

Jun 4, 2024

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Progressive Return to Activity (Group 1)

The current practice, Progressive Return to Activity (PRA) based on Traumatic Brain Injury Center of Excellence (TBICoE) protocols, provides a framework for activity progression based on participant symptom reports and recovery. PRA TBICoE includes a graded approach for clinicians to return participants to pre-injury activities based on the severity of the participant symptoms with and without physical exertion.

experimental: Active Rehab (Group 2)

Active Rehab includes an adaptive paradigm based on personal characteristics, symptom presentation, and duty requirements that integrate with current progressive return to activity (PRA TBICoE) 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 as reported by the participant.

The intervention consists of 5 phases designed to facilitate an active approach to concussion rehabilitation. Phases are symptom stabilization, impairment reduction, activity integration, recovery acceleration, and military duty specific application. Participants complete phase specific activities under direction of a clinical professional, and progress upon meeting specific requirements.

Interventions

Active Rehab (Group 2)

The Active Rehab protocol builds off of initial chief complaints and duty profile and addresses symptom control followed by a progressive and prescribed integration of activities to full return to duty that should be integrated with the current PRA TBICoE protocols. The specific activity areas in the intervention include low-intensity aerobic exercise that does not exacerbate symptoms, cognition, balance, visual/vestibular, and comfort/ general well-being.

Participants can be progressed daily according to symptom limitations. At least 3-4 sessions each week are recommended based on a trial of sport-related mTBI and other interventions of this type concerning mTBI/concussion. During each phase, low level aerobic exercise that does not significantly exacerbate symptoms, such as nature walks, will be recommended. The additional activity types that may be chosen include cognitive, balance, visual/vestibular, and comfort/general well-being.

Progressive Return to Activity (Group 1)

Participant will be asked to use symptoms to guide activity from the time of the injury until participant is asymptomatic. Once asymptomatic, participant will begin the PRA TBICoE clinical recommendation. During this time clinicians will document activities in each stage in addition to initial symptom checklist, stage of PRA CoE progression, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.

Primary outcome measure

  • Average days to full return to duty clearance [ Time Frame: 1 to approximately 360 days ]

Central Contacts and Locations

Central contacts

Johna K Register-Mihalik, PhD

919-962-2702johnakay@email.unc.edu

Paula Gildner, MPH

919-966-0465pgildner@unc.edu

Locations

United States Special Operations Command

Recruiting

Fort Liberty, North Carolina, United States, 28310

Contacts

Stephen DeLellis, PA-C

910-580-4021sdelellis@genevausa.org

Principal Investigator:

Stephen DeLellis, PA-C

Womack Army Medical Center

Recruiting

Fort Liberty, North Carolina, United States, 28310

Contacts

Courtney Jones, PT, DPT, OCS

910-907-8258courtney.v.jones8.mil@health.mil

Principal Investigator:

Courtney Jones, PT, DPT, OCS

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Concussion, Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-27.