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Development of a Concussion Management Platform for Children and Youth

NCT05471791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Concussion, Brain

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • McMaster Children's Hospital

    collaborator OTHER

  • Montreal Children's Hospital of the MUHC

    collaborator OTHER

  • Hamilton-Wentworth Catholic District School Board

    collaborator UNKNOWN

  • McMaster University

    lead OTHER

Principal Investigators

  • Carol A DeMatteo, MSc · McMaster University FHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2024-06-15
Completion
2024-06-15

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05471791 on ClinicalTrials.gov