Status:
RECRUITING
A Pragmatic Rehabilitation Intervention: The Active Rehab Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
United States Department of Defense
Conditions:
Concussion, Brain
Eligibility:
All Genders
18-99 years
Phase:
NA
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) condu...
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 (G...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05320822
Start Date
June 4 2024
End Date
September 1 2026
Last Update
January 28 2025
Active Locations (2)
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1
United States Special Operations Command
Fort Liberty, North Carolina, United States, 28310
2
Womack Army Medical Center
Fort Liberty, North Carolina, United States, 28310