← Back to Search

Back2Play App for Concussion Recovery in Youth (Back2PlayApp Trial)

N/A

Waitlist Available

Led By Carol A DeMatteo, MSc

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surveyed 3 months after completion of study (6 months maximum from enrollment)

Awards & highlights

Back2PlayApp Trial Summary

This trial will evaluate if an App can help youths recover from concussion faster and reduce risk of reinjury.

Who is the study for?

This trial is for children and youth who have been diagnosed with a concussion, are currently experiencing symptoms, and are within 4 weeks of their diagnosis. It's not suitable for those with multiple injuries, developmental delays, or severe brain injury that needed resuscitation or surgery.Check my eligibility

What is being tested?

The study tests the Back2Play App designed to help young people recover from concussions by following established guidelines. The app aims to prevent re-injury and reduce symptom severity during recovery lasting up to 3-6 months post-concussion.See study design

What are the potential side effects?

Since this intervention involves using an application rather than medication, traditional side effects aren't expected. However, there may be indirect effects related to the management of concussion recovery.

Back2PlayApp Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surveyed 3 months after completion of study (6 months maximum from enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surveyed 3 months after completion of study (6 months maximum from enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and surveyed 3 months after completion of study (6 months maximum from enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number and severity of Post-concussive symptoms (PCSS)

Rate of re-injury

Secondary outcome measures

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

Time to recovery from concussion

Back2PlayApp Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: App groupExperimental Treatment1 Intervention

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

Group II: Usual CareActive Control1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hamilton-Wentworth Catholic District School BoardUNKNOWN

1 Previous Clinical Trials

362 Total Patients Enrolled

McMaster Children's HospitalOTHER

38 Previous Clinical Trials

17,144 Total Patients Enrolled

Montreal Children's Hospital of the MUHCOTHER

29 Previous Clinical Trials

114,430 Total Patients Enrolled

Media Library

Back2Play App Clinical Trial Eligibility Overview. Trial Name: NCT05471791 — N/A

Concussion Research Study Groups: App group, Usual Care

Concussion Clinical Trial 2023: Back2Play App Highlights & Side Effects. Trial Name: NCT05471791 — N/A

Back2Play App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471791 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals over the age of 70 excluded from participation in this research?

"According to the eligibility requirements, this clinical trial is open to those aged 10-18. Additionally, there are 28 studies being conducted for minors and 41 trials that target elderly individuals over 65 years old."

Answered by AI

Who meets the criteria to participate in this clinical investigation?

"This trial is looking for 160 volunteers aged 10 to 18, who have recently been diagnosed with a concussion and are still experiencing symptoms. Qualification criteria include an official diagnosis of concussion not more than 4 weeks old."

Answered by AI

How many individuals are eligible for this examination?

"Indeed, the clinicaltrials.gov database indicates that this experiment is currently searching for participants. This research was initially posted on October 6th 2022 and updated as recently as February 28th 2023. The trial needs to enlist 160 people from two different facilities."

Answered by AI

Is this research actively recruiting participants?

"Affirmative. Clinicaltrials.gov hosts information indicating that this clinical trial, first posted on October 6th 2022, is currently enrolling participants. To reach their goal of 160 individuals, 2 sites are being utilized for recruitment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development of a Concussion Management Platform for Children and Youth

2022. "Development of a Concussion Management Platform for Children and Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05471791.

All > Concussion