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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surveyed 3 months after completion of study (6 months maximum from enrollment)

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

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

Primary study objectives

Change in number and severity of Post-concussive symptoms (PCSS)

Rate of re-injury

Secondary study objectives

System Usability Scale (SUS) (for the App group only)

Time to recovery from concussion

Awards & Highlights

No Placebo-Only Group

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

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

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