A Pragmatic Rehabilitation Intervention: The Active Rehab Study

Official title

A Pragmatic Rehabilitation Intervention to Supplement Progressive Return to Activity Following Mild Traumatic Brain Injury in Service Members (SMs): The Active Rehab Study

Overview

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.

Detailed description

The study population will be soldiers stationed at Fort Bragg, North Carolina. Allocation to arm will be determined by time (preintervention/current practice (Group 1) vs. intervention/Active Rehab (Group 2)). The study will enroll and follow mild traumatic brain injuries in the study population, presenting to study targeted providers within 2 weeks following mild traumatic brain injury/concussion, over two 9 month periods (n=65 in each period for a total n=130 completing the protocol). Post-injury patient outcomes include military performance, physiological, clinical and psychological health outcomes. Study assessment timepoints include initial post-injury intake, 2-weeks post enrollment (as possible), asymptomatic, and clearance to return to duty. In the first 9-month period (Study Phase 1), the study will evaluate current progressive return to activity practices and patient outcomes following mild traumatic brain injury.

In the second 9-month period (Study Phase 2), soldier participants will complete the Active Rehab protocol. Active Rehab activities will be progressed based on participants' reported symptoms and duty profiles. The intervention will be delivered through provider and study staff education to participants. Outcomes will be compared between the two study phases (current practice vs. Active Rehab). Following data acquisition, investigators will utilize Machine Learning techniques to develop an adaptive clinical Active Rehab protocol for military settings (Study Phase 3). The algorithm will use serial measures of military performance, physiological function, clinical recovery, and psychological health status obtained at acutely and sequentially throughout treatment to direct best options for an individual's Active Rehab protocol progression.

Interventions

• 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 a
• 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 rat

Primary outcome measures

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

Secondary outcome measures (9)

• Average days to asymptomatic [Time frame: 1 to approximately 240 days]
• Heart Rate Variability (HRV) [Time frame: up to approximately 346 days after intervention initiation]
• Cognitive Status using the Military Acute Concussion Evaluation 2 (MACE 2) [Time frame: up to approximately 346 days after intervention initiation]
• Near point convergence (NPC) [Time frame: up to approximately 346 days after intervention initiation]
• Coordination using the Balance Error Scoring System (BESS) Total Score [Time frame: up to approximately 346 days after intervention initiation]
• Neurobehavioral Symptom Inventory total score and individual symptom scores [Time frame: up to approximately 346 days after intervention initiation]
• Quality of Life Perception (PROMIS) [Time frame: up to approximately 346 days after intervention initiation]
• Health-related fatigue using the Neuro-QOL Fatigue Scale [Time frame: up to approximately 346 days after intervention initiation]
• Health-related cognition using the Neuro-QOL Cognition Scale [Time frame: up to approximately 346 days after intervention initiation]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• United States Special Operations Command — Fort Liberty
• Womack Army Medical Center — Fort Liberty

Identifiers

NCT: NCT05320822 · 20-2904 · CDMRP-PT190088

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗