Active Rehabilitation for Concussion

(ARM Trial)

Recruiting at 3 trial locations

Overseen By Johna K Register-Mihalik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Third mTBI, Moderate-Severe TBI, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help soldiers recover more quickly from mild traumatic brain injuries (mTBI), such as concussions. It compares the usual return-to-activity method with a new "Active Rehab" approach, which tailors exercises and activities to personal needs and symptoms. The goal is to determine if this new method can help soldiers return to their duties faster and improve overall recovery. Active duty military personnel at Fort Bragg who have recently been diagnosed with a mild concussion might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery strategies for soldiers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this active rehabilitation protocol is safe for soldiers with mTBI?

Research has shown that active rehabilitation (rehab) for mild traumatic brain injury (mTBI) is safe. In past studies, participants in active rehab reported that their symptoms rarely worsened. Starting this rehab within a month of the injury is considered safe and might even speed up recovery.

Evidence indicates that gradually returning to activities is also safe. Starting physical therapy (exercises and treatments to aid recovery) soon after a concussion is linked to quicker recovery. However, returning to full activity too quickly can prolong symptoms.

Both treatments are generally well-tolerated and may aid recovery after a concussion. The key is to gradually increase activity based on symptom changes and personal comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for concussion because they offer a more personalized and potentially faster path to recovery. The Active Rehab protocol adapts to individual needs by considering personal characteristics, symptom presentation, and specific duty requirements, aiming to accelerate recovery with its five-phase approach. Unlike the standard Progressive Return to Activity, which primarily relies on symptom reports for activity progression, Active Rehab combines this with an adaptive progression system that is designed to integrate seamlessly with the current guidelines while focusing on safely speeding up the recovery process.

What evidence suggests that this trial's treatments could be effective for improving outcomes following mild traumatic brain injury?

Research has shown that active rehabilitation after a concussion can enhance recovery. One study found that a personalized program focusing on exercise, balance, and specific sports skills reduced symptoms in young people. For adults with ongoing symptoms after a mild traumatic brain injury (mTBI), specialized rehabilitation proved effective. These methods aim to speed up recovery by tailoring activities to each person's needs and progress. In this trial, participants will be assigned to one of two approaches: the Active Rehab method, which adapts based on personal characteristics and symptom presentation, or the Progressive Return to Activity method, which uses guidelines to help individuals with concussions safely resume normal activities. Both methods show promise for improving concussion recovery. ^{4 6 7 8 9}

Who Is on the Research Team?

Johna K Register-Mihalik, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Report to clinic/provider at Fort Bragg and available for recruitment within 2 weeks of mTBI injury date as indicated in medical record

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

Current active duty military personnel stationed at Fort Bragg, North Carolina

Exclusion Criteria

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

My symptoms improve within 48 hours both at rest and when active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Symptom Stabilization

Participants undergo initial stabilization of symptoms post-injury, focusing on managing acute symptoms and preparing for rehabilitation.

2 weeks

Initial visit (Baseline); 2 weeks after intervention initiation

Impairment Reduction

Activities focus on reducing impairments through targeted rehabilitation exercises and therapies.

4 weeks

Activity Integration

Participants begin integrating activities into their daily routine, guided by symptom presentation and recovery progress.

4 weeks

Recovery Acceleration

Focus on accelerating recovery through increased activity levels and monitoring of symptoms.

4 weeks

Military Duty Specific Application

Participants engage in activities specific to military duties to ensure readiness for return to duty.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clearance to return to duty.

up to 346 days

Determination of asymptomatic state; clearance to full return to duty

What Are the Treatments Tested in This Trial?

Interventions

• Active Rehab
• Progressive Return to Activity

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Rehab (Group 2) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A pilot study involving 20 youth aged 9 to 17 showed that early active rehabilitation (AR) starting 2 weeks post-concussion is safe and acceptable, with only two adverse events reported.

Both early AR and standard AR led to a decrease in postconcussion symptoms over time, suggesting that further research is warranted to evaluate the potential efficacy of early AR compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Early Active Rehabilitation for Concussion Recovery in Youth: A Randomized Trial. Dobney, DM., Grilli, L., Beaulieu, C., et al.[2021]

Primary care providers play a vital role in managing concussions, but many lack current knowledge on best practices for safely returning patients to activity after injury, which can affect recovery outcomes.

The DVBIC Progressive Return to Activity study shows that both too rapid and too slow increases in activity levels post-concussion can lead to poorer recovery, highlighting the importance of provider training in effective management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for Progressive Return to Activity after Concussion: Lessons Learned from a Prospective Study of U.S. Military Service Members. Ettenhofer, ML., Remigio-Baker, RA., Bailie, JM., et al.[2021]

This study is a randomized clinical trial evaluating the efficacy of an active rehabilitation protocol for youth with persistent postconcussion symptoms, comparing it to standard care education over a 6-week period.

The active rehabilitation group will engage in low-intensity exercises aimed at reducing symptoms and improving overall function, with outcomes measured for symptom reduction and recovery in cognitive, motor, psychosocial, and emotional areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of persistent postconcussion symptoms in youth: a randomised control trial protocol. Reed, N., Greenspoon, D., Iverson, GL., et al.[2019]

Participation in an Active Rehabilitation (AR) program significantly reduced post-concussion symptom severity in 277 children and adolescents, with median scores improving from 18 before the program to 9.5 after (p < .05).

The AR program effectively addressed various symptoms, including physical, cognitive, emotional, and sleep-related issues, although female participants showed higher symptom severity at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an active rehabilitation program for concussion management in children and adolescents. Dobney, DM., Grilli, L., Kocilowicz, H., et al.[2019]

The study involving 19 adolescents with persistent postconcussion symptoms showed that an active rehabilitation program is safe and well-tolerated, with no participants dropping out and only minor symptom exacerbations reported.

Active rehabilitation was found to be more effective than standard treatment alone in reducing symptoms, indicating its potential as a beneficial intervention for adolescents recovering from sport-related concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. Chan, C., Iverson, GL., Purtzki, J., et al.[2018]

In a study of 68 patients with moderate-to-severe traumatic brain injury (TBI), those undergoing high-intensity rehabilitation (4 hours/day) showed a faster recovery, achieving higher scores on the Functional Independence Measure (FIM) and Glasgow Outcome Scale (GOS) in the early months compared to those in a lower intensity program (2 hours/day).

While early intensive rehabilitation improved recovery speed, it did not significantly change the final functional outcomes, suggesting that while it helps patients regain independence sooner, it may not affect long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Zhu, XL., Poon, WS., Chan, CC., et al.[2014]

In a study involving 49 youth aged 8 to 17 years, an active rehabilitation intervention (ARI) did not significantly reduce postconcussion symptoms (PCS) compared to standard care, but it did improve quality of life and reduce anger in participants after 6 weeks.

The experimental group showed trends towards better balance and less fatigue, suggesting that while ARI may not directly impact PCS, it can enhance overall well-being and functional recovery in young individuals recovering from concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Exercise-Based Active Rehabilitation Intervention for Youth Who Are Slow to Recover After Concussion. Gauvin-Lepage, J., Friedman, D., Grilli, L., et al.[2021]

The systematic review included 13 studies on return to activity (RTA) and return to school (RTS) protocols for children aged 5-18 with concussions, revealing limited evidence on their effectiveness in this age group.

Current recommendations suggest that children should have 1-2 days of physical and cognitive rest after a concussion before gradually returning to activities, as prolonged rest may worsen symptoms and delay recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of return to activity and return to school protocols for children postconcussion: a systematic review. DeMatteo, C., Bednar, ED., Randall, S., et al.[2022]

Traditional post-concussion management emphasized both cognitive and physical rest, but the definition of 'rest' has been unclear and inconsistent in recommendations.

Recent evidence suggests that returning to light or moderate activity earlier may actually help improve symptoms, indicating a shift towards active rehabilitation as a beneficial strategy in concussion recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Active Recovery and "Rest" After Concussion. Strelzik, J., Langdon, R.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7046089/

Active Recovery from Concussion - PMC - PubMed Central - NIH (38) showed that an individualized program of aerobic exercise, balance, and sport specific skills improved symptoms in children and adolescents (age 7 to 18 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6856221/

The Active Rehab Study - PMC - PubMed Central There are limited data promoting a systematic approach to early rehabilitation and post-concussion activity that is modifiable throughout the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S000399931931305X

Management of Concussion and Mild Traumatic Brain Injury At least 3 million Americans sustain a mild traumatic brain injury (mTBI) each year, and 1 in 5 have symptoms that persist beyond 1 month.

4. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/2333

Effectiveness of specialized rehabilitation after mild ... Objective: To determine the effectiveness of specialized rehabilitation in adults with prolonged symptoms, or risk of prolonged symptoms, ...

5. dsc.duq.edu dsc.duq.edu/cgi/viewcontent.cgi?article=1041&context=dnp

Active Rehabilitation Following Sports Concussion It will include data analysis of the impact of exercise on standardized symptom ratings, cognitive scores, and time to full recovery with a comparison of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38775119/

Safety Outcomes From the Active Rehab Study Participants in MDR + EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392842/

Active Rehabilitation Following Acute Mild Traumatic Brain ... The findings show that active rehabilitation that is undertaken within one month of mild traumatic brain injury is safe and decreased the time taken for ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02988596

Role of Rehabilitation in Concussion Management: A ... Approximately 420 professional and amateur athletes will participate in rehabilitation during recovery after sports-related concussion.

9. cochranelibrary.com cochranelibrary.com/central/doi/10.1002/central/CN-01615329/related-content

Safety of Active Rehabilitation for Persistent Symptoms ... Safety, acceptability and outcomes following early active rehabilitation for concussion recovery ... Cervico-vestibular Rehabilitation for Mild Traumatic Brain ...