Back2Play App for Concussion Recovery in Youth

(Back2PlayApp Trial)

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to aid young people in recovering from concussions. The Back2Play App follows guidelines that help users gradually return to activities like school and sports, aiming to reduce the chance of reinjury and speed up recovery. Participants will be divided into two groups: one using the app and the other receiving standard care, typically in the form of written guidelines. Young people diagnosed with a concussion and still experiencing symptoms within four weeks of diagnosis might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery strategies for young people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Back2Play App is safe for youth concussion recovery?

Research has shown that young people generally like the Back2Play App. In tests, 66% found the app very acceptable, and none considered it unacceptable. This app aids recovery from concussions by adhering to well-researched guidelines for safely returning to activities and school. Although direct safety data is lacking, the app's emphasis on these guidelines suggests it is safe to use. As a digital tool rather than a medication, it poses a very low risk of physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Back2Play App for concussion recovery because it offers a digital approach to supporting youth during their recovery. Unlike traditional methods, which often rely on printed guidelines and physician follow-ups, the app provides real-time, interactive guidance tailored to each user's progress. This tech-savvy solution could make it easier for young patients to adhere to recovery protocols, potentially speeding up their return to normal activities. Additionally, the app's data collection feature might help doctors better understand and track recovery patterns, leading to more personalized care.

What evidence suggests that the Back2Play App is effective for concussion recovery in youth?

Research has shown that the Back2Play App, available to participants in this trial, may aid young people in recovering more effectively from concussions. The app follows CanChild guidelines, which outline effective recovery steps. Early results suggest that using the app could lead to fewer re-injuries during recovery and might also reduce the frequency and severity of symptoms like headaches. Additionally, testing has demonstrated that most young users find the app easy to use and enjoyable. These findings support the idea that the app could be beneficial in managing concussion recovery. ^{1 2 4 5 6}

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+

Citations

1. canchild.ca canchild.ca/discover-canchild/current-studies/the-back2play-app-study/

The Back2Play App Study The RCT will evaluate whether the Back2Play App shortens the duration and intensity of concussion symptoms and prevents repeat injury in children and youth.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05471791

Study Details | NCT05471791 | Development of a ... It is hypothesized that participants who use the App will have better outcomes from concussion, primarily less reinjury during the vulnerable period throughout ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S1947315X25000063

The Headaches of Developing a Concussion App for Youth Results of usability testing show that the Back2Play app was highly acceptable to 66% of youth and none found it unacceptable. Successful clinical app ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT05471791/Prot_SAP_000.pdf

Bridging the Gap Between Research and Pr The Back2Play App was developed in phase 1 of this project, to capture self reported symptoms and stages of recovery that youth indicate by ...

5. withpower.com withpower.com/trial/phase-concussion-brain-7-2022-2b936

Back2Play App for Concussion Recovery in Youth ... It is hypothesized that participants who use the App will have better outcomes from concussion, primarily less reinjury during the vulnerable period throughout ...

6. dl.acm.org dl.acm.org/doi/10.4018/IJEHMC.352514

The Headaches of Developing a Concussion App for Youth Results of usability testing show that the Back2Play app was highly acceptable to 66% of youth and none found it unacceptable. Successful ...