Development of a Concussion Management Platform for Children and Youth (Back2PlayApp)

January 8, 2026 updated by: McMaster University

Development of a Concussion Management Platform for Children and Youth: Bridging the Gap Between Research and Practice

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 months after concussion. They may also experience reduced frequency and severity of symptoms and recover more quickly from their concussion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children 10- 18 years of age will be recruited from Emergency departments in Hamilton, Ontario and Montreal, Quebec as well as from community physicians, school boards and sporting organizations. All participants will be randomized to either the App (intervention) group or to Usual care (control) group.

Those in the App group will be loaned an Apple watch (and iPhone if they don't have one). The App is designed to monitor self-reported symptoms and stages of recovery and combine these results with their activity and heart rate data collected by the watch. Notifications are sent through the App based on this data that may help youth adhere to the Return to Activity and Return to School (RTA/RTS) guidelines. Participants will fill out symptom surveys in the App up to 3 times daily, record their physical and cognitive activities and assign themselves a stage of recovery; RTA 1-6, RTS 1-5. The homepage of the App reminds them of what stage they are in of RTA and RTS as well as how much light, moderate and vigorous activity is encouraged for their individual stage of recovery. They will receive notifications about activity level and heart rate if these go outside the recommended limits. App users will also receive motivational statements and encouragement.

The control group will receive usual care with the approach provided in health care systems in their community. This often involves a handout with some type of graduated rest and return to play advice. These participants will complete the initial Post Concussion Symptom Scale at their entry into the study and will be sent daily symptom and activity surveys by our secure data capture system (REDCap) to complete. They will also be asked to self-select their stage of concussion recovery daily for both activity and school.

All participants will be scheduled for a zoom interview after their symptoms are gone, or 3 months after enrolling for those who do not achieve full recovery during the study. They will be asked questions about: 1) their understanding and experience with concussion recovery, 2) whether they experienced another head injury and 3) if those who used the App liked it and found it helpful. 3 months after study completion, participants will receive another survey asking if they have experienced any additional head injuries. Those using the App will be given the System Usability Scale (SUS) to objectively rate the App for potential future commercialization.

All data will be analyzed as discussed in the study protocol. Data may also be used fill in the architecture of a machine learning algorithm running in the background of the Back2Play App to use in predicting RTA/RTS stages for participants in future iterations of the App.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3Z 1X3
        • Montreal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • diagnosed concussion
  • symptomatic
  • within 4 weeks of diagnosis

Exclusion Criteria:

  • developmental delay
  • significant brain injury requiring resuscitation, admission to PCCU or surgical intervention
  • multisystem injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App group
Participants will use the Back2Play App to support them in following the guidelines for recovery from concussion
Device: Back2Play App
This App uses the Apple watch to monitor activity level and heart rate and combines this with self reported symptoms and stage of recovery to send notifications, suggestions and provide resources to help participants adhere to the guidelines.
No Intervention: Usual Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of re-injury
Time Frame: Surveyed 3 months after completion of study (6 months maximum from enrollment)
Survey-report on whether another concussion has occurred. Yes/No response
Surveyed 3 months after completion of study (6 months maximum from enrollment)
Change in number and severity of Post-concussive symptoms (PCSS)
Time Frame: Throughout the study until recovered or up to a maximum of 3 months after enrolment
Daily surveys of 22 concussion symptoms (1symptom/0 no symptoms) for # of symptoms. Included in these surveys is report of symptom changes (gone, better, same or worst) that will help to evaluate changes by stage of recovery and over the course of recovery.
Throughout the study until recovered or up to a maximum of 3 months after enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery from concussion
Time Frame: Through study completion, an average of 1 month, up to 6 months post-enrollment
Measurement of time from injury to when youth have recovered (return to activity stage 6/return to school stage 5)
Through study completion, an average of 1 month, up to 6 months post-enrollment
System Usability Scale (SUS) (for the App group only)
Time Frame: upon completion of study (max 3 months post enrollment)
10 item questionnaire using a Likert scale with five response options for measuring usability of a system (App) 1=strongly disagree 5= strongly agree; Scores are converted to an overall percentage with 70% and above a good score
upon completion of study (max 3 months post enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)
McMaster Children's Hospital
Natural Sciences and Engineering Research Council, Canada
Montreal Children's Hospital of the MUHC
Hamilton-Wentworth Catholic District School Board

Investigators

  • Principal Investigator: Carol A DeMatteo, MSc, McMaster University FHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRP 538798-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The plan is to share all IPD that underlie results in a publication.

IPD Sharing Time Frame

Data will be available 9 months and ending 36 months after article publication.

IPD Sharing Access Criteria

Proposals for data analysis will be considered if there is a methodologically sound request. All requests should go through the PI dematteo@mcmaster.ca

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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