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Active Rehabilitation for Concussion (ARM Trial)

N/A
Waitlist Available
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

ARM Trial 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.Check my eligibility
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.See study design
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.

ARM Trial 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.

ARM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average days to full return to duty clearance
Secondary outcome measures
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

ARM 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.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
856 Previous Clinical Trials
225,465 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,498 Previous Clinical Trials
4,176,082 Total Patients Enrolled
Johna K Register-Mihalik, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Active Rehab Clinical Trial Eligibility Overview. Trial Name: NCT05320822 — N/A
Concussion Research Study Groups: Active Rehab (Group 2), Progressive Return to Activity (Group 1)
Concussion Clinical Trial 2023: Active Rehab Highlights & Side Effects. Trial Name: NCT05320822 — N/A
Active Rehab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05320822 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility for my involvement in this clinical investigation?

"Those with concussion and/or brain injury, aged between 18 and 99 years old, are eligible to participate in this medical trial. The goal is to recruit a total of 130 participants."

Answered by AI

Is this investigation currently admitting participants?

"According to the clinicaltrials.gov website, this clinical trial is not currently recruiting participants as it was last modified on August 9th 2022. Despite that fact, there are approximately 77 other studies actively enrolling patients at present."

Answered by AI

Is this medical research open to those over 40 years of age?

"Patients that wish to be included in this medical study must fit within the 18-99 year old age range. For those below 18, there are 26 other clinical trials available and for those over 65, 35 different studies can be found."

Answered by AI
~87 spots leftby Dec 2024