A Pragmatic Rehabilitation Intervention: The Active Rehab Study

NCT05320822 | Recruiting DMC

• 2 other identifiers: 20-2904CDMRP-PT190088
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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

Keywords

Concussion, Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Average days to full return to duty clearance

  Average number of days from injury to clearance to full return to duty (date return to duty as reported by participant when returned to duty with no limitations or restrictions minus date of injury)

  1 to approximately 360 days

Secondary Outcomes (9)

• Average days to asymptomatic

  1 to approximately 240 days

• Heart Rate Variability (HRV)

  up to approximately 346 days after intervention initiation

• Cognitive Status using the Military Acute Concussion Evaluation 2 (MACE 2)

  up to approximately 346 days after intervention initiation

• Near point convergence (NPC)

  up to approximately 346 days after intervention initiation

• Coordination using the Balance Error Scoring System (BESS) Total Score

  up to approximately 346 days after intervention initiation

Study Arms (2)

Progressive Return to Activity (Group 1)

ACTIVE COMPARATOR

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.

Other: Progressive Return to Activity (Group 1)

Active Rehab (Group 2)

EXPERIMENTAL

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.

Other: Active Rehab (Group 2)

Interventions

Progressive Return to Activity (Group 1) OTHER

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.

Progressive Return to Activity (Group 1)

Active Rehab (Group 2) OTHER

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.

Active Rehab (Group 2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• United States Department of Defense: collaborator

Study Sites (2)

United States Special Operations Command

Fort Liberty, North Carolina, 28310, United States

RECRUITING

Womack Army Medical Center

Fort Liberty, North Carolina, 28310, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Johna K Register-Mihalik, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johna K Register-Mihalik, PhD

CONTACT

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

Paula Gildner, MPH

CONTACT

919-966-0465; pgildner@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: April 11, 2022
• Study Start: June 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC, as allowed by the Department of Defense.

Locations

US (2)