Home Exercise Program for Concussion

(Concussion HEP Trial)

Overseen By Robert Van Pelt, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Texas Scottish Rite Hospital for Children

Disqualifiers: Age ≥18, Seizures, Chronic headaches, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home exercise program can aid concussion recovery. Researchers seek to understand adherence to these exercises at home and participants' perceptions of them. They will also assess the exercises' impact on symptoms and the return to normal activities, such as sports or school. The trial is suitable for children under 18 who have had a concussion within the last month and are experiencing ongoing symptoms. Participants will track their exercises and symptoms for two weeks and share their experiences with their doctors. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective recovery strategies for concussions in children.

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 doctor.

What prior data suggests that this home exercise program is safe for concussion recovery?

Research has shown that home exercise programs for the neck and balance are generally safe for people recovering from concussions. Studies have found that these exercises can reduce symptoms without causing major side effects. For example, one study on a vision and balance exercise program found that participants did not report any serious problems during follow-up visits, suggesting that most people can handle these exercises well. Another study found that balance rehabilitation, similar to the home exercise program being tested, improved symptoms in children after a concussion. This further supports the idea that these exercises are safe and helpful for concussion recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cervico-vestibular home exercise program for concussion because it empowers patients to actively participate in their recovery from home. Unlike traditional treatments that often rely on rest and gradual return to activity under clinical supervision, this program provides structured exercises that target neck and balance systems, helping to alleviate concussion symptoms more dynamically. By using the Medbridge GO app and a paper exercise log, patients can track their progress and tailor the intensity of their exercises based on their symptoms, offering a personalized approach to recovery.

What evidence suggests that this home exercise program is effective for concussion recovery?

Research has shown that exercises for the neck and balance system, known as cervico-vestibular rehabilitation, can reduce symptoms after a concussion. One study found that 73.3% of patients performing these exercises returned to sports within eight weeks, compared to only 7.1% in a group that did not. This trial will evaluate the effectiveness of a cervico-vestibular Home Exercise Program, which participants will follow. These exercises have reduced dizziness and improved balance in both adults and children after a concussion. Overall, they seem promising for helping people recover from concussion symptoms and return to normal activities. ^{2 6 7 8 9}

Who Is on the Research Team?

Shane Miller, MD

Principal Investigator

Scottish Rite for Children

Are You a Good Fit for This Trial?

This trial is for individuals recovering from sprains, strains, concussions, or traumatic brain injuries. Participants will be asked to perform and monitor exercises at home aimed at aiding their recovery over two weeks.

Inclusion Criteria

Diagnosed with a concussion at their clinic visit

Parent/patient must be fluent in English

I am under 18 years old.

Exclusion Criteria

Moderate and severe TBI

History of >3 prior concussions

Presenting to clinic >1 month after injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants complete a cervico-vestibular home exercise program over a two-week period

2 weeks

1 initial visit (in-person), 1 follow-up contact (phone/email/text)

Follow-up

Participants are monitored for adherence and effectiveness of the exercise program

1-3 weeks

1 follow-up visit (in-person)

Optional Follow-up

Participants may be contacted to assess return to play/learn status and continued exercise adherence

1 month post-initial visit

What Are the Treatments Tested in This Trial?

Interventions

• Cervico-vestibular Home Exercise Program

Trial Overview The study tests the feasibility of a cervico-vestibular exercise program done at home by patients after a concussion. It looks into how well patients stick to it, whether they find it acceptable, its effect on symptoms, and when doctors usually prescribe such programs.

How Is the Trial Designed?

Group I: Home Exercise Program Experimental Treatment 1 Intervention

Patients will be given an informational handout by clinical athletic trainers that provides information about the study, the exercises in their exercise program, a detailed progression to higher HEP levels/intensities based on their symptoms, and a walkthrough on how to log their progression in the Medbridge GO app. They will also receive a paper exercise log in which they can mark their progression in the different HEP levels/intensities each day until their follow-up visit, their symptoms before and after completing the exercises, if the exercises worsen their symptoms, and if they were able to complete their daily exercises.

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials

23

Recruited

9,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9819464/

Effectiveness of Vestibular Rehabilitation after Concussion VR seems useful to reduce symptoms in patients with concussion; however, a huge heterogeneity of the studies and of the outcomes used were found.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02988323

Cervicovestibular Physiotherapy and Aerobic Exercise in ... Many individuals who sustain a concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may suffer from persistent symptoms. Little ...

3. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/128282-effectiveness-of-vestibular-rehabilitation-in-children-post-

Effectiveness of Vestibular Rehabilitation in Children Post ... Vestibular rehabilitation therapy (VRT) has been shown to substantially decrease dizziness and improve gait and balance function in adults post ...

4. bjsm.bmj.com bjsm.bmj.com/content/47/5/e1.50

Cervico-vestibular physiotherapy in the treatment ... Results One of 14 subjects (7.1%) in the control group and 11 of 15 subjects (73.3%) in the treatment group were medically cleared to return to sport at 8 weeks ...

5. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-019-0139-3

Cervicovestibular rehabilitation in adult with mild traumatic ... Controlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35102743/

Cervicovestibular Rehabilitation in Adults with Mild ... The primary outcome was the Post-Concussion Symptoms Scale (PCSS). The secondary outcomes were Numerical Pain Rating Scale (NPRS), Neck Disability Index (NDI), ...

7. liebertpub.com liebertpub.com/doi/full/10.1089/neu.2021.0508?doi=10.1089/neu.2021.0508

Cervicovestibular Rehabilitation in Adults with Mild ... The objective of this study was to compare the effects of a cervicovestibular rehabilitation program combined with symptom-limited aerobic ...

8. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2023.1064771/full

The effect of a home exercise program on visio-vestibular ... Our primary purpose was to investigate the effect of a visio-vestibular home exercise program (VV-HEP) on concussion symptom reporting during follow-up visits ...

9. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/128282-effectiveness-of-vestibular-rehabilitation-in-children-post-concussion-a-systematic-review

Effectiveness of Vestibular Rehabilitation in Children Post ... VRT shows promise and may result in symptom improvements in children post-concussion when used as part of a multimodal intervention plan.