Clinical trial NCT05320822: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Brain
Keywords: Concussion, Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-04-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Average days to full return to duty clearance
timeFrame: 1 to approximately 360 days
Secondary outcomes:
measure: Average days to asymptomatic
timeFrame: 1 to approximately 240 days
measure: Heart Rate Variability (HRV)
timeFrame: up to approximately 346 days after intervention initiation
measure: Cognitive Status using the Military Acute Concussion Evaluation 2 (MACE 2)
timeFrame: up to approximately 346 days after intervention initiation
measure: Near point convergence (NPC)
timeFrame: up to approximately 346 days after intervention initiation
measure: Coordination using the Balance Error Scoring System (BESS) Total Score
timeFrame: up to approximately 346 days after intervention initiation
measure: Neurobehavioral Symptom Inventory total score and individual symptom scores
timeFrame: up to approximately 346 days after intervention initiation
measure: Quality of Life Perception (PROMIS)
timeFrame: up to approximately 346 days after intervention initiation
measure: Health-related fatigue using the Neuro-QOL Fatigue Scale
timeFrame: up to approximately 346 days after intervention initiation
measure: Health-related cognition using the Neuro-QOL Cognition Scale
timeFrame: up to approximately 346 days after intervention initiation
Other outcomes:
Locations:
city: Fort Liberty
country: United States
facility: United States Special Operations Command
state: North Carolina
city: Fort Liberty
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Johna K Register-Mihalik, PhD
role: PRINCIPAL_INVESTIGATOR
References: