Combined Rehabilitation Program for Post-Concussion Syndrome

Overseen By Hiba Al-Hakeem, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: ASD, Physical disability, Intellectual disabilities, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist young people who have experienced concussion symptoms for at least four weeks by offering a group program that includes exercise circuits, skills training, and mental health support. Caregivers will receive support through educational sessions to better assist their children. The trial will test various approaches, including virtual and in-person sessions for both youth and caregivers. It is suitable for youth aged 8-21 with ongoing concussion symptoms who have internet access for online sessions. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for concussion recovery.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have found controlled exercise to be safe and well-tolerated for people with post-concussion syndrome. Research shows that aerobic exercise, when done without overexertion, is safe. Participants in similar studies rarely reported worsening symptoms during exercise.

Studies on similar programs have shown encouraging results regarding goal-setting. They indicate that setting and achieving goals can be safe and beneficial for people with concussion symptoms.

Research suggests that educational support for caregivers is effective and safe. Caregivers who learn about managing concussions and coping strategies often feel more supported and better equipped to help their children.

Overall, existing research has shown the treatments in this program to be safe. Participants in these programs often report very few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Combined Rehabilitation Program for Post-Concussion Syndrome because it offers a holistic approach that combines physical and educational strategies. Unlike traditional treatments, which may focus solely on physical or cognitive therapy, this program integrates exercise circuits with psychoeducation for both youth and their caregivers. The unique blend of cardiovascular fitness, stress management, and advocacy skills sessions aims to address not just the physical symptoms of concussions but also emotional and social aspects, potentially leading to improved overall recovery and quality of life. Additionally, the inclusion of caregivers in the process provides family-based support that is often missing in standard care, fostering a more supportive recovery environment.

What evidence suggests that this trial's treatments could be effective for post-concussion syndrome?

Research has shown that exercise routines can help treat post-concussion syndrome (PCS). In this trial, participants in the "Move&Connect-Youth" arm will follow planned exercise programs to enhance balance, coordination, and strength. Studies indicate that starting physical activity soon after a concussion can reduce symptoms and speed up recovery. Additionally, the trial includes psychoeducation for both young people and their caregivers. Participants in the "Move&Connect-Caregiver" arm will learn about the condition and coping strategies, which can improve family relationships and support. For young people, learning to manage stress and mood can enhance mental health and quality of life. Overall, these methods offer a comprehensive approach to managing PCS symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrea Hickling, MScOT, OT Reg. (Ont.)

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Shannon Scratch, PhD, C Psych

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for young people aged 8-21 with a concussion diagnosed by a healthcare professional, still having symptoms after 4 weeks. They must be willing to attend weekly sessions and have internet access. Caregivers fluent in English with internet can also join.

Inclusion Criteria

Willing to engage in weekly sessions

I am between 8 and 21 years old and can agree to participate.

Caregiver to youth experiencing PPCS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants engage in weekly sessions focusing on active rehabilitation and psychoeducation for youth, and psychoeducational support for caregivers.

6 weeks

6 visits (virtual or in-person)

Follow-up

Participants are monitored for changes in concussion symptoms, self-efficacy, quality of life, mental health, and social support.

3 months

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Circuits
• Goal Setting
• Psychoeducation-Caregiver
• Psychoeducation-Youth
• Waitlist Control Surveys

Trial Overview Move&Connect tests an interdisciplinary program combining exercise circuits, goal setting, mental health support, and educational information for youth with concussions and their caregivers against a waitlist control group.

How Is the Trial Designed?

Group I: Move&Connect-Youth-Virtual Experimental Treatment 3 Interventions

* Sessions run weekly via Zoom videoconferencing by a registered physiotherapist and occupational therapist for one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up. * Weekly sessions taking place over Zoom will include an active rehabilitation component including exercises focused on cardiovascular fitness, balance, co-ordination and strength. * Weekly sessions will also include an educational component through focused discussions on topics including headache management, stress coping skills, mood coping skills, fatigue management, advocacy skills, and goal setting. * Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in concussion symptoms, self-efficacy, quality of life, mental health and social support.

Group II: Move&Connect-Youth Waitlist control Experimental Treatment 1 Intervention

The control group will be recruited from the waitlist for the Persistent Concussion Clinic and the Early Care Concussion Clinic at Holland Bloorview, in addition to partnered community medical offices and organizations. For the control group, the research assistant will schedule the participants first session to obtain consent and provide youth/caregivers with week 1 questionnaires. At this time, the participants will be able to ask any questions related to the study. After eight weeks the control group will be asked to complete the post measures in order to mimic the length of the intervention. The control group will then be given the opportunity to enroll in one of the intervention arms of the Move\&Connect study. They will then follow the same approved procedures for the intervention treatment group. Youth and their caregivers will be able to participate as waitlist controls without completing the intervention, if they choose.

Group III: Move&Connect-Youth Experimental Treatment 3 Interventions

* Sessions run weekly at the Bloorview Research Institute by a registered physiotherapist and occupational therapist for one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up. * Weekly sessions will include an active rehabilitation component including exercises focused on cardiovascular fitness, balance, co-ordination and strength. * Weekly sessions will also include an educational component through focused discussions on topics including headache management, stress coping skills, fatigue management, advocacy skills, and goal setting. * Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in concussion symptoms, self-efficacy, quality of life, mental health and social support.

Group IV: Move&Connect-Caregiver-Virtual Experimental Treatment 1 Intervention

* The treatment sessions run once a week using Zoom videoconferencing and last approximately one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up. * Caregivers will participate in a group-based psychoeducational support group with sessions consisting of focused discussions on topics including: the ripple effect, school advocacy, child well-being, family functioning, parenting, and stress \& daily challenges. The sessions will be run by a clinical neuropsychologist and social worker. * Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in their youth's concussion symptoms, and mental health, as well as parental self-efficacy, quality of life, mental health and social support.

Group V: Move&Connect-Caregiver Waitlist control Experimental Treatment 1 Intervention

The control group will be recruited from the waitlist for the Persistent Concussion Clinic and the Early Care Concussion Clinic at Holland Bloorview, in addition to partnered community medical offices and organizations. For the control group, the research assistant will schedule the participants first session to obtain consent and provide youth/caregivers with week 1 questionnaires. At this time, the participants will be able to ask any questions related to the study. After eight weeks the control group will be asked to complete the post measures in order to mimic the length of the intervention. The control group will then be given the opportunity to enroll in one of the intervention arms of the Move\&Connect study. They will then follow the same approved procedures for the intervention treatment group. Youth and their caregivers will be able to participate as waitlist controls without completing the intervention, if they choose.

Group VI: Move&Connect-Caregiver Experimental Treatment 1 Intervention

* The treatment sessions run once a week at the Bloorview Research Institute and last approximately one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up. * Caregivers will participate in a group-based psychoeducational support group with sessions consisting of focused discussions on topics including: the ripple effect, school advocacy, child well-being, family functioning, parenting, and stress \& daily challenges. The sessions will be run by a clinical neuropsychologist and social worker. * Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in their youth's concussion symptoms, and mental health, as well as parental self-efficacy, quality of life, mental health and social support.

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

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

Active Recovery from Concussion - PMC - PubMed Central - NIH The results of these studies are supporting the safety, tolerability, and potential efficacy of active rehabilitation for adolescents with PCS. A recent quasi- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9897009/

The Effectiveness of Physical Therapy Interventions for ... Systematic reviews have shown that exercise post-concussion can improve symptom scores after concussion and that sub-symptomatic aerobic ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X16300335

Multimodal impairment-based physical therapy for the ... Patients improved on average 9 points on the post-concussion symptom scale. Patients improved with exercise tolerance and postural stability.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815228

Optimal Volume of Moderate-to-Vigorous Physical Activity ... Early engagement in physical activity has been associated with reduced symptom burden at 2 weeks postinjury, faster recovery, and a lower risk ...

5. journals.humankinetics.com journals.humankinetics.com/view/journals/jsr/28/2/article-p211.xml

Subsymptomatic Aerobic Exercise for Patients With ... There is moderate evidence to support subsymptomatic aerobic exercise as a treatment of PCS; therefore, it should be considered as a clinical option.

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999317312510

Safety of Active Rehabilitation for Persistent Symptoms ... The results support the safety, tolerability, and potential efficacy of active rehabilitation for adolescents with persistent postconcussion symptoms. Section ...

8. bjsm.bmj.com bjsm.bmj.com/content/57/12/762

Rest and exercise early after sport-related concussion Early PA, prescribed aerobic exercise and reduced screen time are beneficial following SRC. Strict physical rest until symptom resolution is not effective.

9. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2723523

Early Subthreshold Aerobic Exercise for Sport-Related ... The data provide preliminary evidence that a primary benefit of early subthreshold exercise treatment is a reduced incidence of delayed recovery (>30 days), ...