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Combined Rehabilitation Program for Post-Concussion Syndrome

N/A

Recruiting

Led By Shannon Scratch, PhD, C Psych

Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with a concussion by a physician or nurse practitioner and are experiencing concussion symptoms for ≥ 4 weeks post concussion.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8, 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial offers a program combining skills training, mental health support, and active rehabilitation for youth who have had a concussion, with caregiver involvement.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like exercise and education rather than drugs or medical procedures, traditional side effects are not expected; however, participants may experience fatigue or stress from engagement in the activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was diagnosed with a concussion and have had symptoms for over 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8, 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8, 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up

Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up

Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up

+2 more

Secondary study objectives

Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up

Change from baseline Healthy Lifestyle and Behaviours Checklist at 8-weeks and 3-month follow up

Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0 - Anxiety short form 8a at 8-weeks and 3-month follow up.

+8 more

Other study objectives

Satisfaction Survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Move&Connect-Youth-VirtualExperimental Treatment3 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 controlExperimental Treatment1 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-YouthExperimental Treatment3 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-VirtualExperimental Treatment1 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 controlExperimental Treatment1 Intervention

Group VI: Move&Connect-CaregiverExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Goal Setting

2017

N/A

~200

0 / 1Eligibility criteria met