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Active Rehabilitation for Concussion (ARM Trial)

N/A

Recruiting

Led By Johna K Register-Mihalik, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed via medical record

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to approximately 360 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether providing injured soldiers with activities to do as part of their rehabilitation will help them recover more quickly and improve their cognitive and functional limitations.

Who is the study for?

This trial is for active duty military personnel at Fort Bragg who have had a mild traumatic brain injury (mTBI) or concussion within the past two weeks. They must not have had more than two concussions in the last year and should be able to complete initial study assessments.

What is being tested?

The study tests 'Active Rehab' against standard 'Progressive Return to Activity'. Active Rehab includes personalized activities that align with current guidelines but aim to speed up recovery based on symptoms and duty requirements.

What are the potential side effects?

Since this trial involves rehabilitation exercises rather than medication, side effects may include physical discomfort or temporary increase in symptoms during activity progression, depending on individual tolerance and condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My doctor diagnosed me with a mild traumatic brain injury or concussion within 2 weeks of my injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to approximately 360 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to approximately 360 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to approximately 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average days to full return to duty clearance

Secondary study objectives

Average days to asymptomatic

Cognitive Status using the Military Acute Concussion Evaluation 2 (MACE 2)

Coordination using the Balance Error Scoring System (BESS) Total Score

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active Rehab (Group 2)Experimental Treatment1 Intervention

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.

Group II: Progressive Return to Activity (Group 1)Active Control1 Intervention

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.

0 / 1Eligibility criteria met