Development of a Concussion Management Platform for Children and Youth
NCT ID: NCT05471791
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
181 participants
INTERVENTIONAL
2022-10-06
2024-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Online Treatment Recovery Assistance for Concussion in Kids
NCT05065099
Pediatric Concussion Assessment of Rest and Exertion
NCT02893969
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
NCT05819268
Ketogenic Diet Program for Epilepsy
NCT02497105
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
NCT02118220
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
App group
Participants will use the Back2Play App to support them in following the guidelines for recovery from concussion
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.
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* symptomatic
* within 4 weeks of diagnosis
Exclusion Criteria
* significant brain injury requiring resuscitation, admission to PCCU or surgical intervention
* multisystem injury
10 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Natural Sciences and Engineering Research Council, Canada
OTHER
McMaster Children's Hospital
OTHER
Montreal Children's Hospital of the MUHC
OTHER
Hamilton-Wentworth Catholic District School Board
UNKNOWN
McMaster University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol A DeMatteo, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University FHS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McMaster Children's Hospital
Hamilton, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
CanChild Research centre website with Back2Play App study updates
CanChild published Return to Activity and Return to School guidelines for Youth recovering from concussion
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHRP 538798-19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.