Development of a Concussion Management Platform for Children and Youth — Back2PlayApp  

Concussion, Brain Clinical Trial

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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

• NCT number: NCT05471791
• Study type: Interventional
• Source: McMaster University
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2022
• Completion date: December 31, 2024