RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

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.

OTHER

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.

Locations (2)

United States Special Operations Command

Fort Liberty, North Carolina, United States

Womack Army Medical Center

Fort Liberty, North Carolina, United States