All > Concussion

Move&Connect-Youth-Virtual for Post-Concussion Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Holland Bloorview Kids Rehabilitation Hospital, East York, CanadaPost-Concussion SyndromeExercise Circuits - Other
Eligibility
8 - 21
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 11 Secondary · Reporting Duration: baseline, week 8, 3-month follow-up

Week 8
Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
Month 3
Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
Week 8
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Depression at 8-weeks and 3-month follow up
Week 8
Satisfaction Survey
Semi-Structured Exit Interview
Week 8
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.
Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0-Depressive Symptoms short form 6a at 8-weeks and 3-month follow up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0 Fatigue Short form 10a at 8-weeks and 3-month follow up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Anxiety at 8-weeks and 3-month follow up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Depression at 8-weeks and 3-month follow up
Change from baseline Pediatric Quality of Life Index: Generic Core Scales at 8-weeks and 3-month follow up
Change from baseline Progressive Activities of Controlled Exertion- Self Efficacy at 8-weeks and 3-month follow up
Change from baseline University of California, Los Angeles Loneliness Scale at 8-weeks and 3-month follow up

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pain, Stress and Emotions
1
Formal pre-operative education
1
Connect Staff-based PA intervention

Trial Design

4 Treatment Groups

Move&Connect-Youth-Virtual
1 of 4
Move&Connect-Youth
1 of 4
Move&Connect-Caregiver
1 of 4
Move&Connect-Caregiver-Virtual
1 of 4

Experimental Treatment

150 Total Participants · 4 Treatment Groups

Primary Treatment: Move&Connect-Youth-Virtual · No Placebo Group · N/A

Move&Connect-Youth-VirtualExperimental Group · 3 Interventions: Exercise Circuits, Goal Setting, Psychoeducation-Youth · Intervention Types: Other, Behavioral, Behavioral
Move&Connect-YouthExperimental Group · 3 Interventions: Exercise Circuits, Goal Setting, Psychoeducation-Youth · Intervention Types: Other, Behavioral, Behavioral
Move&Connect-Caregiver
Behavioral
Experimental Group · 1 Intervention: Psychoeducation-Caregiver · Intervention Types: Behavioral
Move&Connect-Caregiver-Virtual
Behavioral
Experimental Group · 1 Intervention: Psychoeducation-Caregiver · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goal Setting
2017
N/A
~200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 8, 3-month follow-up

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
59 Previous Clinical Trials
12,827 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
456 Patients Enrolled for Post-Concussion Syndrome
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,245 Previous Clinical Trials
24,677,718 Total Patients Enrolled
Shannon Scratch, PhD, C PsychPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
Andrea Hickling, MScOT, OT Reg. (Ont.)Study DirectorHolland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria

Age 8 - 21 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 8 and 21 years old and able to give your own consent or agreement to participate.
You understand the study and are able to agree to participate.
You need to have a strong and dependable internet connection.
You are able to attend weekly sessions and are willing to do so.
You were diagnosed with a concussion by a doctor or nurse and you are still experiencing symptoms four weeks after the diagnosis.
You need to have a good and dependable internet connection.
You are taking care of a young person who has PPCS.
You must be able to speak English fluently.
References

Frequently Asked Questions

Is the enrollment period of this clinical trial still ongoing?

"Affirmative. Information available on clinicaltrials.gov attests that this study, which was initially publicized on November 14th 2022, is actively recruiting patients. Approximately 150 subjects are sought from 1 medical centre for participation in the trial." - Anonymous Online Contributor

Unverified Answer

What is the objective of this research endeavor?

"This clinical trial's primary measure of success, which will be tracked at Baseline, 8 weeks and the 3-month follow-up mark is a change in Health and Behavior Inventory scores. Secondary objectives encompass an Exit Interview to assess changes in ongoing concussion symptoms, education levels and social support; additionally, measurements of depression using Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0 (scored 1 - 5 with higher numbers indicating more depressive symptoms) as well as anxiety via the same scale are being monitored throughout the course of this study." - Anonymous Online Contributor

Unverified Answer

Does this research program permit individuals under 60 to participate?

"This trial has set the age eligibility requirement between 8 and 21 years of age." - Anonymous Online Contributor

Unverified Answer

What is the current enrolment size for this trial?

"Affirmative, the information on clinicaltrials.gov shows that this trial is actively seeking participants. It was initially posted on 14th November 2022 and recently updated on 25th November 2022 with a goal of recruiting 150 individuals from one location." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this medical study?

"This trial is attempting to recruit 150 individuals aged 8-21 years old exhibiting post-concussion syndrome. To be eligible, patients must meet the following criteria: have a physician/nurse practitioner diagnosed concussion and at least 4 weeks of symptoms, consent capacity, fluency in English, access to internet connection for weekly sessions with caregivers present." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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