Development of a Concussion Management Platform for Children and Youth

Concussion, Brain Clinical Trial

— Back2PlayApp  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05471791
• Other study ID #: CHRP 538798-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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- 6 months after concussion. They may also experience reduced frequency and severity of symptoms and recover more quickly from their concussion.

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.

Participants will by directed by the Back2Play App to a companion App called Braingames triggered by recording progress in their stage of returning to school. The Braingames App is a cognitive screen made up of 5 neuro-cognitive tests; 1) Finger tapping, 2) Divided Attention, 3) Memory for Designs, 4) Path tracing and 5) Face emotion matching. These tasks appear to be particularly sensitive in detecting deficits post-concussion. The tasks are in a game format on the App and responses are collected and feedback provided to the youth as to their readiness to progress to greater cognitive challenges by demonstrating that If these tests provoke more symptoms, participants may want to consider if they are ready to move up a stage in return to school.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 181
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Montreal Children's Hospital	Montréal	Quebec

Sponsors (6)

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

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Time to recovery from concussion	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
Secondary	System Usability Scale (SUS) (for the App group only)	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)

External Links

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