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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
United States Special Operations Command
RECRUITING
Fort Liberty
Womack Army Medical Center
RECRUITING
Fort Liberty
Contact Information
Primary
Johna K Register-Mihalik, PhD
johnakay@email.unc.edu
919-962-2702
Backup
Paula Gildner, MPH
pgildner@unc.edu
919-966-0465
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2026-09
Participants
Target number of participants: 130
Treatments
Active_comparator: Progressive Return to Activity (Group 1)
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.
Experimental: Active Rehab (Group 2)
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.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov