Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT05320822

A Pragmatic Rehabilitation Intervention: The Active Rehab Study

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-27

130

Participants Needed

2

Research Sites

117 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Pragmatic Rehabilitation Intervention: The Active Rehab Study

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Current active duty military personnel stationed at Fort Bragg, North Carolina
  • Available for recruitment within 2 weeks of mild traumatic brain injury (mTBI) injury date
  • Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed by medical record
Not Eligible

You will not qualify if you...

  • Three or more mTBI/concussions in the past 12 months
  • Symptoms resolved at rest and exertion within 48 hours
  • Moderate to severe traumatic brain injury or TBI not meeting mild criteria
  • Other injuries preventing completion of initial assessments within 2 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

United States Special Operations Command

Fort Liberty, North Carolina, United States, 28310

Actively Recruiting

2

Womack Army Medical Center

Fort Liberty, North Carolina, United States, 28310

Actively Recruiting

Loading map...

Research Team

J

Johna K Register-Mihalik, PhD

CONTACT

P

Paula Gildner, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here