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A Pragmatic Rehabilitation Intervention: The Active Rehab Study

ConditionConcussion, Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Rehab (Group 2)

    Other intervention

    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)

    Other intervention

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Progressive Return to Activity (Group 1)Active comparator 1 intervention
Group B: Active Rehab (Group 2)Experimental treatment 1 intervention

Trial outcomes

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)

Time frame
1 to approximately 360 days

Secondary outcomes

1

Average days to asymptomatic

Average number of days from injury to asymptomatic, determined as when no neurobehavioral symptom inventory (NSI) symptom is greater than 1.

Time frame
1 to approximately 240 days
2

Heart Rate Variability (HRV)

Heart rate variability (HRV) will be assessed during seated (parasympathetic dominant) and standing (sympathetic dominant) conditions. The conditions will be assessed over three, five minute intervals. Twice when the participant is seated, and once while the participant is standing. Assessment of these conditions allows for assessment of response to a change in state. Assessed at: Initial visit (Baseline); determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

Time frame
up to approximately 346 days after intervention initiation
3

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

The MACE 2 will be used to assess cognitive status after acute injury. The MACE 2 has demonstrated validity, reliability, and sensitivity to concussion. The MACE 2 is a multimodal tool that assists in the assessment and diagnosis of concussion. It contains sections on orientation, immediate memory, concentration, and delayed memory. The sum scores from all sections are used to calculate a total score. Total score ranges from 0-30. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

Time frame
up to approximately 346 days after intervention initiation
4

Near point convergence (NPC)

Near-point convergence is a commonly used oculomotor exam that defines the amplitude of convergence or the closest point in space where the participant can hold fusion, and therefore, see one target. Participants complete 3 trials assessing near-point convergence, distance in centimeters, and the average of the three trials is recorded. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

Time frame
up to approximately 346 days after intervention initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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