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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Active Rehab, Progressive Return to Activity for concussion?

Research shows that active rehabilitation, which includes exercises and activities, can help reduce symptoms and improve recovery in children and adolescents who take longer to recover from a concussion. This approach is more effective than just resting, especially for those with ongoing symptoms. ^{1 2 3 4 5}

Is active rehabilitation safe for people with concussions?

Research shows that active rehabilitation, which includes activities like aerobic exercise and coordination drills, is generally safe for children and adolescents recovering from concussions, even if their symptoms persist. ^{1 4 5 6 7}

How does the Active Rehabilitation treatment for concussion differ from other treatments?

Active Rehabilitation for concussion is unique because it involves an early, structured return to light or moderate activity, rather than prolonged rest, which has traditionally been recommended. This approach aims to reduce persistent symptoms and improve recovery by gradually increasing activity levels, which may help facilitate symptomatic improvement. ^{1 3 5 8 9}

Research Team

Johna K Register-Mihalik, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Early Active Rehabilitation for Concussion Recovery in Youth: A Randomized Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of an Exercise-Based Active Rehabilitation Intervention for Youth Who Are Slow to Recover After Concussion. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of an active rehabilitation program for concussion management in children and adolescents. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Management of persistent postconcussion symptoms in youth: a randomised control trial protocol. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of return to activity and return to school protocols for children postconcussion: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Role of Active Recovery and "Rest" After Concussion. [2017]

9. United States 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. [2021]