Development of a Concussion Management Platform for Children and Youth

NCT05471791 | Completed

• 1 other identifier: CHRP 538798-19
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

youth or children; mHealth

Outcome Measures

Primary Outcomes (2)

• Rate of re-injury

  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)

  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 Outcomes (2)

• Time to recovery from concussion

  Through study completion, an average of 1 month, up to 6 months post-enrollment

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

  upon completion of study (max 3 months post enrollment)

Study Arms (2)

App group

EXPERIMENTAL

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

Device: Back2Play App

Usual Care

NO 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

Interventions

Back2Play App DEVICE

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.

App group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed concussion
• symptomatic
• within 4 weeks of diagnosis

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3Z 1X3, Canada

Location

Related Publications (4)

• DeMatteo CA, Lin CA, Foster G, Giglia L, Thabane L, Claridge E, Noseworthy MD, Hall GB, Connolly JF. Evaluating Adherence to Return to School and Activity Protocols in Children After Concussion. Clin J Sport Med. 2021 Nov 1;31(6):e406-e413. doi: 10.1097/JSM.0000000000000800.

  PMID: 31876794 BACKGROUND

• DeMatteo C, Bednar ED, Randall S, Falla K. Effectiveness of return to activity and return to school protocols for children postconcussion: a systematic review. BMJ Open Sport Exerc Med. 2020 Feb 24;6(1):e000667. doi: 10.1136/bmjsem-2019-000667. eCollection 2020.

  PMID: 32153982 BACKGROUND

• DeMatteo C, Randall S, Falla K, Lin CY, Giglia L, Mazurek MF, Koelink E. Concussion Management for Children Has Changed: New Pediatric Protocols Using the Latest Evidence. Clin Pediatr (Phila). 2020 Jan;59(1):5-20. doi: 10.1177/0009922819879457. Epub 2019 Oct 18.

  PMID: 31625406 BACKGROUND

• DeMatteo CA, Randall S, Lin CA, Claridge EA. What Comes First: Return to School or Return to Activity for Youth After Concussion? Maybe We Don't Have to Choose. Front Neurol. 2019 Jul 23;10:792. doi: 10.3389/fneur.2019.00792. eCollection 2019.

  PMID: 31396150 BACKGROUND

Related Links

• CanChild Research centre website with Back2Play App study updates
• CanChild published Return to Activity and Return to School guidelines for Youth recovering from concussion

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Carol A DeMatteo, MSc

  McMaster University FHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial comparing treatment (use of mobile App) to usual care

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: July 25, 2022
• Study Start: October 6, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: January 12, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 9 months and ending 36 months after article publication.
• 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

Locations

CA (2)