Back2Play App for Concussion Recovery in Youth

(Back2PlayApp Trial)

Recruiting at 1 trial location

Overseen By Samantha Perrotta, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Developmental delay, significant brain injury, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 months

181 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This multi-centred, randomized controlled trial will evaluate the effectiveness of a pilot tested mobile device Application built to guide youth in recovery from concussion. The Back2Play App was developed based on the published and researched CanChild Return to Activity (RTA) and Return to School (RTS) guidelines, which outline graduated steps in returning to play and school for youth after a concussion. It is hypothesized that participants who use the App will have better outcomes from concussion, primarily less reinjury during the vulnerable period throughout their recover up to 3- 6 months after concussion. They may also experience reduced frequency and severity of symptoms and recover more quickly from their concussion.

Who Is on the Research Team?

Carol A DeMatteo, MSc

Principal Investigator

McMaster University FHS

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Within 4 weeks of diagnosis

I am experiencing symptoms from my condition.

I have been diagnosed with a concussion.

Exclusion Criteria

I have had a serious brain injury that needed intensive care or surgery.

Developmental delay

Multisystem injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Back2Play App or receive usual care to support recovery from concussion

3 months

Daily self-reports via App or REDCap

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a zoom interview and surveys

3 months

Zoom interview and survey 3 months post-enrollment

Long-term follow-up

Participants receive a survey 3 months after study completion to report any additional head injuries

3 months post-study completion

What Are the Treatments Tested in This Trial?

Interventions

• Back2Play App

Trial Overview 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.

How Is the Trial Designed?

Group I: App group Experimental Treatment 1 Intervention

Participants will use the Back2Play App to support them in following the guidelines for recovery from concussion

Group II: Usual Care Active Control 1 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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton-Wentworth Catholic District School Board

Collaborator

Trials

2

Recruited

540+

McMaster Children's Hospital

Collaborator

Trials

43

Recruited

19,900+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+