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Back2Play App for Concussion Recovery in Youth (Back2PlayApp Trial)

N/A
Waitlist Available
Led By Carol A DeMatteo, MSc
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surveyed 3 months after completion of study (6 months maximum from enrollment)
Awards & highlights

Back2PlayApp Trial Summary

This trial will evaluate if an App can help youths recover from concussion faster and reduce risk of reinjury.

Who is the study for?
This trial is for children and youth who have been diagnosed with a concussion, are currently experiencing symptoms, and are within 4 weeks of their diagnosis. It's not suitable for those with multiple injuries, developmental delays, or severe brain injury that needed resuscitation or surgery.Check my eligibility
What is being tested?
The study tests the Back2Play App designed to help young people recover from concussions by following established guidelines. The app aims to prevent re-injury and reduce symptom severity during recovery lasting up to 3-6 months post-concussion.See study design
What are the potential side effects?
Since this intervention involves using an application rather than medication, traditional side effects aren't expected. However, there may be indirect effects related to the management of concussion recovery.

Back2PlayApp Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surveyed 3 months after completion of study (6 months maximum from enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and surveyed 3 months after completion of study (6 months maximum from enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in number and severity of Post-concussive symptoms (PCSS)
Rate of re-injury
Secondary outcome measures
System Usability Scale (SUS) (for the App group only)
Time to recovery from concussion

Back2PlayApp Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: App groupExperimental Treatment1 Intervention
Participants will use the Back2Play App to support them in following the guidelines for recovery from concussion
Group II: Usual CareActive Control1 Intervention
Participants will receive usual care which often means they are provided concussion recovery guidelines in handout format and receive whatever follow up is deemed necessary by treating physician

Find a Location

Who is running the clinical trial?

Hamilton-Wentworth Catholic District School BoardUNKNOWN
1 Previous Clinical Trials
362 Total Patients Enrolled
McMaster Children's HospitalOTHER
38 Previous Clinical Trials
17,144 Total Patients Enrolled
Montreal Children's Hospital of the MUHCOTHER
29 Previous Clinical Trials
114,430 Total Patients Enrolled

Media Library

Back2Play App Clinical Trial Eligibility Overview. Trial Name: NCT05471791 — N/A
Concussion Research Study Groups: App group, Usual Care
Concussion Clinical Trial 2023: Back2Play App Highlights & Side Effects. Trial Name: NCT05471791 — N/A
Back2Play App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471791 — N/A
~70 spots leftby Jun 2025
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