Development of a Concussion Management Platform for Children and Youth: Bridging the Gap Between Research and Practice
Phase: NA
Conditions: Concussion, Brain
Sponsor: McMaster University

Development of a Concussion Management Platform (Back2Play App) for Children 
and Youth: Bridging the Gap Between Research and Practice   
 
Hamilton Integrated Research Ethics Board Project 14504 
 
June 1 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
1
PROTOCOL 
 
Title of Study: 
Development of a Concussion Management Platform (Back2Play 
App) for Children and Youth: Bridging the Gap Between Research 
and Practice  
 
Principal Researcher: 
Prof. Carol DeMatteo – McMaster University 
 
Co-Researchers: 
Dr. Michael Noseworthy (McMaster)  
 
Mr. Morris Hucal (HWCDSB) 
Dr. John Connolly (McMaster) 
Dr. Thomas Doyle (McMaster) 
Dr. Isabelle Gagnon (Montreal Children’s Hospital) 
Dr. Lucy Giglia (McMaster) 
Dr. Geoffrey Hall (McMaster) 
   
              
Dr. Eric Koelink (McMaster) 
Dr. Joyce Obeid (McMaster) 
Dr. Nick Reed (University of Toronto) 
Dr. Brian Timmons (McMaster)  
 
 
 
Sponsor: 
Canadian Institutes of Health Research (CIHR)/Natural Sciences 
and Engineering Research Council (NSERC)  
 
1. STUDY PURPOSE AND RATIONALE 
Katie was an honour roll high school student with a passion for high level competitive 
basketball and won many championships with her school team. Over the course of four 
years, Katie sustained four concussions while playing basketball. She has no memory of 
any of her injuries. In addition, she suffered from daily headaches, nausea, vomiting, 
dizziness, fatigue, fogginess, inability to concentrate and poor memory. Her prolonged 
symptoms caused Katie to miss school, increasing her anxiety around falling behind, 
declining grades, and acceptance to university. Due to a lack of resources and supports 
available, Katie’s parents were at a loss as to how they could help her recover and 
manage her symptoms. She had to wait months for an appointment with a specialist and 
felt hopeless that she would ever feel like herself again. With limited guidance, Katie 
engaged in physical and cognitive activity too soon after injury, ultimately contributing 
to prolonged and worsening symptoms. Her symptoms caused her to withdraw from 
basketball, leading to anxiety, depression and social isolation. Three years after her 
injuries, Katie still deals with some of the lingering concussion symptoms. Her 
headaches are frequent and severe, while memory and concentration interfere daily in 
her scholastic achievement. Katie, a thoughtful and articulate young adult, wishes that 
she had had more specific daily guidance when recovering from her concussion and 
believes if she did, she may have had a quicker and less stressful recovery. 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
2
 
 
The decision regarding return to activity following concussion remains one of the most 
difficult and controversial areas in concussion management - with significant 
repercussions as in Katie’s case. 
Adhering to guidelines for safe return to activity/ school is a challenge for youth. Lack of adherence can 
contribute to prolonged recovery and repeat injuries. Youth like Katie who sustain a concussion 
are predominantly provided with management strategies based on professional 
consensus Return to Activity (RTA) and Return to School (RTS) protocols, with most 
referencing the Berlin Consensus Statement (2017).1 These protocols were designed 
for adult athletes1 and very little monitoring occurs to inform how or when a 
child/youth should progress through the stages. It is notable to the reader that the term 
youth will be applied throughout this document to define our population of interest 
which includes those between the ages of 10 and 18. 
 
Our research team has made significant advances in the management of concussion in 
youth by creating evidence-based child-and-youth-specific protocols for RTA and RTS 
(www.canchild.ca).2 In evaluating these guidelines, our team found that youth had 
difficulties following the protocols due to lack of feedback and guidance.3 Further, 
results from our community-based study, which included the partnering school board, 
showed much variation in the implementation of the concussion protocols in youth 
amateur sport.4  
 
What is needed now – what will help youth like Katie – is a comprehensive 
concussion management platform that can monitor and evaluate symptoms, real-time 
activity monitoring that guide youth on how to adjust activity to minimize symptom 
exacerbation. The aim of this project is to develop a new concussion management 
platform (Back2Play App), which will be available to youth post-concussion via mobile 
device. The platform will guide youth through the revised CanChild RTA and RTS 
Protocols (2018)2; include real-time monitoring of biological variables including heart 
rate, movement, symptoms, and cognitive activity; as well as incorporate new evidence 
on the balance of rest and activity from the CIHR funded ‘Back to Play’2 Study.  
 
Hypothesis - We hypothesize that using the mobile health platform (Back2Play App) 
device will improve adherence to management strategies and will result in quicker 
recovery (defined as a quicker return to activity and school without symptom 
exacerbation, minimize development of Post-Concussion Syndrome (PCS) (greater 
Research Question 
Does a newly developed interactive Back2Play App, available on mobile devices, reduce 
time to symptom resolution and return to full activity and prevent reinjury 3 months after 
initial injury in youth aged 10-18 years with concussive injury as compared to usual care? 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
3
than 1-month symptom duration post injury) and prevent repeat injuries in the early 
vulnerable post-concussive period.  
 
This project will occur in three phases; Phase 1: App Development, Phase 2: Usability 
Testing, and Phase 3; Feasibility RCT. This application is for Phase 3 of the Back2Play App 
study.  Phase 1 and 2 were previously approved (#7393). The study will explore whether a newly 
developed Back2Play App, available on mobile devices, reduces time to symptom 
resolution and time to return to full activity/school and prevents reinjury within three 
months of initial injury in youth aged 10-18 years with concussive injury as compared to 
usual care. 
 
Secondary objectives of this study will be: 
 To conduct a multicentre Randomized Control Trial (RCT) comparing The 
Back2Play App to Usual Care with our partners at Montreal Children’s Hospital 
(MCH), McMaster Children’s Hospital, David Braley Sports Clinic (DBSC) and other 
clinics and community partners  
 To evaluate through survey and interview, the perceptions of The Back2Play App from 
parents and  youth.  
 To explore commercialization of the new product.  
 
Novelty and Significance of the Research - Most existing concussion management apps 
aim to provide education and some method for recording and tracking symptoms. These 
apps are information dense, lack user interaction and fail to integrate child/youth patterns 
of activity with symptom exacerbation to provide guidance about RTA and RTS based on 
evidence-based guidelines. By creating The Back2Play App that incorporates and 
streamlines key aspects of concussion management and monitoring, we will provide youth 
and their families with more autonomy and understanding of their recovery trajectories, 
with the goal of increasing overall adherence. 
 
Return to activity/school is about (i) having adequate recovery time to eliminate or decrease 
symptoms and (ii) adhering to guidelines that gradually increase the amount and level of 
physical and mental activity to control symptom exacerbation1, 5-9.  Activity monitoring 
through accelerometry and symptom tracking through the Post-Concussion Symptom Scale 
(PCSS)10, combined with management protocols that give parameters for these would 
provide individualized feedback that is time sensitive. This mobile application would 
represent advances in individual data collection and adherence monitoring, while suggesting 
alternate activities based on clinically developed RTA/RTS Guidelines. The Back2Play App 
will be tested and refined with youth with concussion providing a realistic measure of clinical 
utility as well as desirability and approval by youth. The App includes a machine learning 
component that is currently observatory in nature, and for the purposes of the current study, 
will not be used to provide feedback to users. 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
4
Development of such techniques could provide insight as to how using these new methods 
may be incorporated into return to activity decision-making, which at present is 
subjectively decided by coaches, clinicians and parents. We believe these new methods of 
evaluation will provide not only the foundation of future research, but also information 
with immediate clinical utility. The Back2Play App is not meant to replace medical 
management but to be a safe adjunct. Long-term, we aim to change the overall 
management and outcomes of childhood concussion. The Back2Play App will have the 
potential to alter the current landscape of pediatric concussion management and research. 
 
This ethics application builds on existing work and previously approved phases (#7393) 
from our 3-phase project:  
 
Phase 1: We developed  The Back2Play App in English and French. The App can monitor 
concussion symptoms, physical and cognitive activity level as well as the stage of the 
RTA/RTS Guidelines to assist in managing concussion recovery in children and youth. 
During this phase, we had 2 participants, youth with concussion, participate in User 
Experience testing sessions at the Institute of Applied Health Sciences at McMaster University. 
User Experience testing sessions are important in the technology industry because they assess 
the customer’s response to a prototype of a product. We asked participants to use the 
Back2Play App on an iPhone and Apple Watch for 1 week and give us feedback on our 
App. Following User Experience, the App development team made improvements (extending 
survey times, language, use of colours) to ensure functionality and ease of use.  
 
Phase 2: In this phase we pilot tested the The Back2Play App with youth. Youth were recruited 
from the Hamilton Wentworth Catholic District School Board (HWCDSB), McMaster 
Children’s Hospital, Montreal Children’s Hospital and Concussion clinics within the 
community.  Unfortunately, because of COVID-19 restrictions the number of youth with 
concussions was low and a total of 17 participants were enrolled in this portion of the study. The 
main goal of the pilot was to test the App’s content and usability at home and school with youth 
and get feedback to redevelop it.  Overall youth reported a high satisfaction rate with The App. 
The System Usability Scale (SUS), which is a 10 item questionnaire administered to participants 
was used due to it’s ease in evaluating software. On the SUS, a mean of 70% and median of 75% 
was achieved.  The SUS reports that 68% is an average score and anything below that may require 
redevelopment. Youth also gave qualitative feedback on timing of surveys and troubleshooting 
issues which are currently being updated in the App. 
 
We were also collecting data to develop machine learning algorithms that will be embedded within 
the Back2Play App prior to Stage 3. This algorithm will be tested and further trained to understand 
what stage of RTA/RTS the youth is in based on their symptom level, heart rate and movement 
data. A support vector machine classification algorithm was built using data from the pilot. 
Because enrollment was so low, the stages of guidelines  were collapsed and the model currently 
predicts Stage 2, 3, 4 and 5 of RTA and 2, 3, and 4 of RTS. The architecture of this algorithm is 
sound but the predictive capabilities need more work, thus the algorithm will sit on the phone in 
the background and predictions will be sent directly to the B2P database. No information from the 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
5
algorithm will be shared with participants or used by The App to provide guidance through 
notifications. 
 
Phase 3: The goal of Phase 3 is to conduct an RCT with our partners (Montreal 
Children’s Hospital, McMaster Children’s Hospital) comparing the effectiveness of the 
innovative Back2Play App versus Usual Care. We will assess whether The Back2Play App 
shortens the duration and intensity of post-concussion symptoms and prevents repeat 
injury in youth post- concussion. To do so we will evaluate: 
1) Total symptoms, symptom severity and duration of symptoms. 
2) Time to symptom resolution. 
3) Risk for repeat head injuries within three months of initial injury. 
 
  
2. BACKGROUND 
 
Concussion, also referred to as mild traumatic brain injury (MTBI), is a major public 
health concern. Despite increased recognition of the serious health impacts of concussion, 
the number of injuries is rising in both Canada and the United States.1 The presentation of 
symptoms after a concussion can have a significant impact on a youth’s participation in 
daily life, including at school and in sport. 
 
Concussion is a common child/youth health problem. In Canada, an estimated 15,970 
patients presented to emergency departments (ED) with a sport-related head injury, 
including concussion, in 2011/12.11 Among children and youth aged 5-18, there was a 
reported 42-47% increase in the proportion of head injuries relative to all other injuries in 
football, soccer and ice hockey between 2004 and 2014.12 The actual number of 
concussion incidents is believed to be even higher given that many injuries go unreported. 
In a prospective Canadian study, Echlin et al.13 observed an incidence of 21.5 
concussions per 100 athlete exposures. 
 
Concussion in children presents with a range of severity and results in short and long-term 
physical (e.g., headache, nausea, balance problems, dizziness, visual problems, fatigue), 
cognitive (e.g., feeling mentally ‘foggy’, difficulty concentrating or remembering), 
emotional/ behavioural (e.g., irritability, sadness, nervousness, anxiety ) and sleep 
dysregulation sequelae which are collectively known as Post-Concussion Syndrome 
(PCS).14-16 These symptoms are usually aggravated by physical and cognitive exertion 
if the child/youth has not fully recovered. Barlow et al.17 note that diagnostic criteria for 
PCS may not vary in the type but in number and/or duration of symptoms present. This 
epidemiologic study from Alberta, Canada17 confirmed that 59% of children/youth 
continued to be symptomatic one-month post-injury, 14% of children remained 
symptomatic three months post-injury and 2.3% were still symptomatic at one year. These 
results are congruent with data collected at the Acquired Brain Injury (ABI) Follow-Up 
Clinic at McMaster Children’s Hospital (MCH). Here, 47% of children/youth still had 4 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
6
symptoms or more at 1 month post concussive injury. There is now a prediction risk score 
for PCS18 which helps clinicians determine at presentation which children will go onto 
have PCS or symptoms past one month. All children/youth still must be monitored to 
determine if their symptoms resolve early or if they are among the 50% of children/youth 
at risk for symptoms lasting greater than one month, or one of the 13% that are 
symptomatic beyond three months post-injury. There is now a growing body of evidence to 
show that with education, comprehensive assessment and rehabilitation, symptom 
resolution may occur sooner and secondary problems like depression and school failure 
can be prevented.19 
 
Multiple concussions are common in the pediatric population 
Swaine et al.20 found that concussed children are twice as likely to receive a subsequent 
head injury within 12 months. Moreover, more than 30% of high school athletes have 
been shown to sustain multiple head injuries.21-22 Greater than 34% of children who 
received service at the ABI Follow-Up Clinic at MCH had experienced multiple 
concussions, with 17% experiencing three or more injuries. 
 
Children who have sustained multiple concussions often have prolonged and severe 
symptoms including learning difficulties, behavioural problems, debilitating headaches, 
visual problems, and impaired memory.23-25 Concussion often results in substantial 
long-term cognitive and behavioural disturbances that can have significant impact on the 
quality of life of individuals.26-27 Our own research supports these findings as we found 
that children with mild injuries had decreased quality of life and neuropsychological 
impairment at five years post-injury compared to norms for age.28 This evidence, in 
combination with the growing body of knowledge surrounding chronic traumatic 
encephalopathy (CTE) (where degeneration has been demonstrated in the brains of athletes 
who have had multiple concussions, some as early as 18 years of age29-30), commands us 
to prevent these repetitive injuries even though we may not yet fully understand the 
mechanisms and individual propensity to this debilitating condition. 
 
Current approaches to concussion management have limitations 
The Berlin Consensus 2016 Concussion in Sport Group (CISG)1, which recently updated 
The Zurich Consensus31, has provided guidelines for return to play for adult athletes 
which major sport and prevention institutions are readily adopting. These consensus 
statements were originally designed to provide general recommendations for the 
management of sport concussion in adults, with the pediatric population being considered 
in subsequent more recent versions. 
 
While children and youth do present with similar post-concussion symptoms as adults, 
several investigators and The Berlin Consensus1 have noted the need for a more 
conservative approach for their concussion management due to the unique physiological 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
7
make-up among the pediatric patients. 32-34The CanChild Protocols for Concussion 
Management for children and youth 5-18 years35-37 used in this proposed study were 
developed with reference to the consensus statements.1 The CanChild protocols highlight 
the need for graduated RTA and RTS management strategies that reflect the pattern of 
recovery that is unique to each child/youth. Focusing on an individual’s unique pattern of 
recovery may better reflect the complicated course of healing that requires more than a 
‘one size fits all’ set of recommendations. 
There are five stages in the CanChild RTS protocol2 and six stages in the RTA protocol.2 
In these protocols, all children/youth are advised that there can be no high-level physical 
activity or contact sport while symptoms are present. However, ‘rest’ does not equate to 
social isolation or sensory deprivation. Daily activities that can be tolerated for each stage 
of recovery, without symptom exacerbation, are identified in the Activity Suggestions 
supplement that accompany the protocols, both of which are available on the CanChild 
website.2 Families often find it difficult to gauge the appropriate amount of activity, 
including cognitive effort, for their child/youth’s stage of recovery. The therapeutic goal 
in managing concussion recovery is to find the individual’s level of cognitive and physical 
exertion that promotes healing which is the focus of our proposed Back2Play App. This 
graded approach was highlighted in a recent systematic review comparing the difference 
in concussion management in children/youth versus adults that was part of the CISG 2016 
meeting in Berlin.1 Importantly, this systematic review identified the need for an effective 
pediatric specific concussion management protocol.38 
 
Current Concussion Management Platforms 
Very little research exists on the use of concussion management platforms for 
treatment/prevention. A total of 5 articles39-43 were retrieved from the PubMed database. As 
noted earlier, the main goal of these apps was to provide education and some method for 
recording and tracking symptoms. The Self-Monitoring Activity-Restriction and Relaxation 
Treatment - SMART provides recommendations for individualized symptom management, 
activity restrictions, guidance, stress management, relaxation and problem-solving skills 
following concussion. The Brain 101: The Concussion Playbook is purely a web-based 
education tool designed for sports-related concussion training. All studies had small sample 
sizes. 
 
Back2Play App 
The Back2Play App was developed in phase 1 of this project, to capture self reported 
symptoms and stages of recovery that youth  indicate by filling in daily surveys and combine 
these with biological/activity data to track progress and give feedback about their recovery 
from concussion based from currently existing published guidelines. Accelerometry and heart 
rate data are collected through the Apple watch and sent to the API as well so that real time 
notifications can be given that may help youth adhere to the RTA/RTS guidelines. All 
notifications are based on published evidence-based guidelines used in clinical practice.  

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
8
(https://canchild.ca/system/tenon/assets/attachments/000/002/642/original/Return_to_Activit
y_Guideline_WEB_1__Reference.pdf ). 
 
Rules, precedingly referred to as ‘business rules’, were developed for in App notifications 
that follow the guidance of the RTA/RTS protocols for progression through the stages 
(Appendix1.1) Symptoms, self reported stages and activities are measured daily in the 
morning, afternoon and evening. A summary of these surveys is found in appendix 1.2. The 
home screen of the App (appendix 1.3) summarizes the next survey time, current stage of 
return to school and activity the youth is reporting that day and the activity minute goals 
(based on their stage of recovery) and how many activity minutes are completed. Icons at the 
bottom direct users to 1) a summary page that will show this information as well as a graph of 
their current symptoms, 2) a charts page which has several graphs of their progress 
(symptoms, stages, heart rate and activity minutes), 3) resources including the CanChild 
guidelines for concussion recovery, symptom strata (or the type of recovery pattern they may 
be following), the playsafe cards for individual sport specific strategies and a list of activity 
suggestions for each stage of recovery and 4) a contact us page which gives the Research 
Team concuss@mcmaster.ca and Principal investigator contact info as well as a form for 
troubleshooting help. When youth fill out the surveys, if 2 or more symptoms are worse, a 
pop up option of texting or emailing the participant’s parent appears (appendix 1.3) 
Notifications are also sent to youth who exceed their activity goals and the Back2Play App 
will send a cautionary message “You are doing too much!” if their heart rate goes above 180. 
Encouraging notifications are also programmed with business rules if participants stay in the 
same stage for extended periods or if their symptoms get worst. 
 
A complimentary App was developed by Dr. Geoff Hall of our investigator team. This Brain 
Games App was designed to screen some typical neurocognitive functions affected by 
concussion. There are 5 “games” that take about 10 minutes to complete. These include 1) 
finger-tapping, 2) divided attention, 3) memory for designs, 4) tracing and 5) face match. An ‘in 
App notification’ is triggered by the youth recording a progression in their RTS stage. “Let’s do 
a brain teaser! Sign into The Back2Play Brain Games App for your brain game then complete 
your symptom survey!” If the challenging tasks result in increased symptoms, The App notifies 
them “The brain game can be hard, stay at this stage if you need too!” 
These tasks may give the user some indication of readiness to move on in their recovery. 
 
3. METHODS 
 
Description of Population and Sample  
Our population consists of male and female youth aged 10-18 years that have been diagnosed 
with a concussion by a physician. Youth presenting to the David Braley Clinic, McMaster 
Children’s Hospital, HWCDSB, Montreal Children’s Hospital or physicians in the 
community will be randomly assigned to the intervention or control groups.  
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
9
A clinically significant effect of 10% decrease in repeat head injury and 10% decrease in 
recovery time would be of interest. The sample size calculation was done using parameters with 
a two sided significance of 0.05 and a power of 0.8 and based on our primary outcome of repeat 
head injury which is a binomial variable. Our anticipated incidence rate was compared to two 
rates of incidence in clinical settings and in the literature:   
• 16% rate common in the literature 
•  our anticipated 2% rate with adherence to protocols (from previous B2P study) N=128 
•  37% rate from concussion clinic at MCH and  
• 13% rate of our pilot data N=100.   
 
The larger number will be sought (sample size takes into consideration 20% refusal rate and loss 
to follow up) therefore we will recruit N=160. With an average of 25-30 new cases per month 
from the  sources outlined above, 60% consent rate, and 12 months recruitment, it is feasible to 
attain this sample of youth.  
 
4. INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion Criteria 
Youth aged 10-18 at the time of injury will be included in this proposal. Youth must have had 
an impact to the head or body and diagnosed with a concussion by a physician. The youth 
must be symptomatic on admission to the study, and be within the first month of their initial 
injury. In addition, youth and their parents/guardians must be able to understand and 
complete questionnaires in English or French.  
 
Exclusion criteria: Youth will be excluded from the study if they 1) have a confirmed 
significant brain injury requiring resuscitation, 2) were admitted to the pediatric critical care 
unit or surgical intervention, and 3) if they suffered a concussion but are no longer 
symptomatic, 4) they have been admitted to the PICU and 5) have been diagnosed with a  
developmental disability. 
 
5. HOW SUBJECTS WILL BE RECRUITED 
 
For Phase 3 of the Back2Play App Development, youth from McMaster Children’s Hospital 
and Montreal Children’s Hospital will be recruited. Both McMaster Children’s Hospital and 
Montreal Children’s Hospital have Research Assistants on staff that will ask if potential 
recruits would like to hear more about the study. A study information letter will be provided 
to those who are interested. Consent and randomization can occur in the ED with Research 
Assistants using an online randomization system (https://www.random.org/lists/).  If parents 
want time to consider whether they wish to participate, the overview of the details of the 
project with the Research Coordinator’s contact information will be sent home with them. If 
later interested, they can contact the Research Co-ordinator who will arrange a time to review 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
10
the consent and possible assent form. Forms outline the project details, explain what 
participation involves, and seek to obtain written consent/assent.  
 
The randomization process will be shared with participants. They will be informed that, due to 
the nature of the project, they may or may not get to use The Back2Play App. If a youth is not 
provided with The Back2Play App, they will be provided the Usual Care. Usual care often 
includes guidelines or protocols to help youth safely return to activity and school. 
 
Participants will also be recruited from HWCDS, concussion clinics and from our Knowledge 
Translation partners in the Hamilton and Burlington community. The incidence of concussion 
has been low to due COVID-19 provincial restrictions and so we must expand our recruitment 
efforts. Principles/Teachers as well as Coaches and Athletic trainers will be given information 
about The Back2Play App Study. If a youth with a diagnosed concussion is identified, the youth 
and their families will be provided a letter of information by their Principal/Teacher/Coach or 
Athletic trainer. This letter will encourage the youth and/or their family to contact the Research 
Coordinator about The Back2Play App Study. Alternatively, the Principal/Teacher/Coach or 
Athletic trainer will be provided a contact form (Appendix 1.4) to collect the contact information 
of the youth their family so that the Research Team can contact the interested participants 
directly. Only youth/their families who consent to provide their information to their 
Principal/Teacher/Coach or Athletic trainer will be contacted directly using the Phone/E-mail 
script, whichever they prefer. 
 
6. PROCEDURES 
 
* COVID-19 restrictions, if applicable: All interactions for the RCT with research staff will 
adhere to McMaster University’s COVID-19 guidelines as well as government 
recommendations/protocols. As such, participants will be provided a combination of In 
Person/Zoom visits. Consent will most often be in person at the hospitals with research staff but 
if participants from the community choose to review consent over Zoom, they will be asked to 
sign consents through REDCap during the meeting. Zoom is an externally hosted cloud-based 
service (https://zoom.us/privacy-and-legal). Participants will be informed of the small risk of a 
privacy breach for data collected on Zoom. Participants will then be encouraged to express their 
concerns about using Zoom and be offered the alternative opportunity to participate via phone. 
An electronic copy of the consent or assent forms will be signed by participants on REDCap.  
 
At the consent visit, regardless of method and site, participants will be fully informed of the 
protocol for each arm of the study (Usual Care and App group). Participants will also be 
informed of their chance (50%) of being assigned to either group. Due to the nature of the study 
participants and researchers are unable to be blinded to their study condition. Once consent is 
obtained, participants will be randomized to The Usual Care or The App group using computer 
generated codes. Those in The App group may be given their devices at the ED. Alternatively, if 
they can’t stay for this they can come into The Institute for Applied Health Sciences (IAHS) 
within 2 days of consent to receive devices and download the App.  If a participant is out of 
reasonable range to visit, devices may be mailed to them via FedEx within 1 day of providing 
consent and a Zoom meeting arranged to help download The App. If participants do not have an 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
11
iPhone above version 6, they will be provided an iPhone and an Apple Watch. They may choose 
to use their own iPhone if they have one with the appropriate model number. Participants will be 
informed that all devices supplied must be returned at the end of the study period. 
 
7. INTERVENTIONS 
 
Participants randomized to the control group will be provided Usual Care which often is some 
type of gradual return guidelines the practice (ED, General Practitioner) subscribes to. These are 
usually provided in a paper format for the patient to take home. Participants in the Usual Care 
group will complete symptom surveys every 24 hours via REDCap. The Back2Play App requests 
symptom surveys be done 3 times daily (quickly done on the watch or phone). The Back2play 
App also asks users to go to the BrainGames App when participants indicate they are ready to 
progress to the next stage of RTS in the guidelines. In The BrainGames App they can complete 5 
neuropsychological tasks that provide feedback about their readiness to progress. These tasks are 
not available for those in the Usual Care group. 
 
Surveys about cognitive and physical activities engaged in as well as the participants self-rating 
of cognitive activity level (1-5) and stage of recovery (1-5/6) are done on a daily basis by both 
groups.  
 
 
 
 
 
 
• Download The Back2Play App and The B2P BrainGames App on their iPhone 
and the Apple Watch provided either at the ED or at a scheduled baseline visit 
(within 2 days of concussion). 
• Pair the Apple Watch to their iPhone and wear an Apple Watch for the duration 
of the study.  
• Complete the initial post-concussion symptom survey on the App with the 
Research Assistant and receive orientation to The Back2Play App. 
• Complete 3 symptom surveys per day on The Back2Play App (Morning, 
Afternoon and Evening) and daily surveys about cognitive and physical activities 
as well as self-rating of participants’ own cognitive level of activity and stage of 
concussion recovery until 2 days following symptom resolution. 
• Complete games on the B2P BrainGames App (i.e. matching games) which are 
suggested whenever the participant moves up a stage in RTS Protocol. 
• Attend a Zoom Follow Up meeting 2 days after symptom resolution or after a 
maximum of 3 months of using The App. Here, we will ask participants questions 
about their perceptions of how well The App guided them through their recovery. 
Did they agree with classifications and notifications, did they understand the 
guidelines as well as questions about any other interventions they may have 
received. This Zoom visit will be recorded and saved to a secure, password 
encrypted study computer.  
Participants who have been randomized to the App group will be asked to: 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
12
• Complete the (SUS) after they have finished using the App (Appendix 1.5). 
Participate in a Follow Up interview (Appendix 1.6) which will assess the youth’s 
experience with their recovery using The Back2Play App, ask about any other 
interventions they had and if they have experienced a repeat injury during the 
time in the study. 
• Delete the App from their phone during this interview and arrange to return (by 
scheduled pick up or FedEx label sent by The Research Assistant) device(s). 
• 3 months following study enrollment, participants will be sent a survey through 
REDCap about reinjury to complete. 
 
 
 
 
 
 
 
 
 
 
• Receive the usual course of care given by the hospital, General Practitioner or 
clinic which may or may not include written guidelines, suggestions or 
resources 
• Complete the initial post-concussive symptom survey with The Research 
Assistant. 
• Complete symptom surveys and daily surveys about cognitive and physical 
activities as well as self-rating of participants’ own cognitive level of activity 
and stage of concussion recovery  every 24 hours emailed by REDCap until 2 
days following symptom resolution. 
• Participate in a Zoom visit 2 days after symptom resolution or after 3 months of 
participation for those who do not achieve symptom resolution. Participants will 
be asked questions regarding their knowledge of and ability to follow the Usual 
Care guidelines they received and about any other interventions they may have 
received. This Zoom visit will be recorded and saved to a secure, password 
encrypted study computer.  
• 3 months following study enrollment, participants will be asked to complete a 
survey about reinjury.  
 
8. DESIGN  
Phase 3 of this study has both quantitative and qualitative components. The aims of the 
qualitative components of the study are to determine if participants liked using The App, and 
if their experiences of using it helped their recovery from concussion. In addition, qualitative 
data will be used to review any improvement suggestions to The App before 
commercialization. Using both qualitative and quantitative research methods we will explore 
Participants who have been randomized to the usual care group will be asked to: 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
13
the usability of The Back2Play App components under consideration for the final version of 
the App to be commercialized.  
 
Primary Research Outcomes 
To assess: 
• Risk for repeat head injuries within three months of study completion (3-6 
months after injury)  
• Duration of symptoms: Time to symptom resolution from date of injury 
 
Secondary Research Outcomes 
To assess: 
1) The frequency of symptoms using PCSS. 
2) Time to return to activity and time to progress through the 6 stages of  RTA 
3) Perceptions of the platform by parents and youth. 
4) Accuracy of the algorithm embedded in the background of The App 
classifying the participant’s stage of recovery  
 
Measures 
Symptoms 
Concussion symptoms will be assessed on The Back2Play App for those randomized to The App 
group and via REDCap for those randomized to Usual Care. A modified version of the PCSS 
(consisting  of 22 symptoms) will be completed by youth in both groups. The Likert scale was 
modified to detect the presence of symptoms rather than symptom severity. Symptom data will 
be collected 3x/day for participants using The Back2Play App and every 24 hours for 
participants in the Usual Care group.  
 
Cognitive Activity 
Cognitive activity will be assessed using a modified version of the scale developed by Brown et 
al. Participants in both groups will be asked to complete this scale once per day through 
REDCAP which will appear as follows: 
“Please rate 1-5 what you’ve been doing today” 
1- None- No reading, homework, text messaging or screen time (T.V., cell phone), can 
talk on phone 
2- Minimal- 15 minutes of screen time or schoolwork 2x daily. Socialize with 1-2 
friends, no longer than 30 minutes, 
3- Moderate- Homework in 15 minutes blocks for a maximum of 45 minutes. Screen 
time/T. V in 15-minute blocks, for up to an hour daily.  
4- High- Complete as much homework as tolerated. 1 test/week or tests with 
accommodation (i.e. longer time to write), less reading, homework and screen time 
than normal 
5- Full- no restrictions to cognitive activity 
 
Cognitive and Physical Activities 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
14
Engagement in cognitive and physical activities will be measured once per day in those using the 
App as well as for those in the Usual Care group. The activities surveyed will match those 
recommended for each stage of RTA/RTS (Appendix 1.2) 
 
Time to Stage  
Participants in both groups will report their stage of RTA/RTS. The time from injury to each 
stage will be used to determine the time to stage and completion of the RTA/RTS guidelines. 
 
Rate of Reinjury 
All participants be asked at study completion and 3 months after symptom resolution if they have 
hit their head again in such a way that they experienced symptom exacerbation or return of 
symptoms for more than one day, if they moved back a stage in the guidelines for recovery, or if 
they sought medical care from hitting their head since the initial injury. 
 
9. DETAILED DESCRIPTION OF METHODOLOGY 
 
9.1. REIMBURSEMENT  
Participants will be reimbursed for parking at all study locations (McMaster University) 
should they decide to attend the visits in person. Participants will be provided with an 
honorarium of $20 for their involvement in the study. If participants in The App group use 
their own phone, they may be provided up to $25 in compensation for data usage on their 
cellular device. 
 
9.2. RISKS 
Some participants may experience worsening of post-concussion symptoms during the 
completion of the study, due to physical or cognitive exertion (headache, dizziness, nausea 
etc.). In the event of worsening post-concussion symptoms, use of The Back2Play App will 
be immediately stopped and resumed only after a minimum period of 24 hours of rest and a 
resolution of symptoms. If participants do not want to continue with the testing, there will be 
no negative consequences. In addition, some participants may feel anxious about using The 
Back2Play App and their performance. The Research Team will explain the use of The 
Back2Play App in detail and will take special care to emphasize that results will be 
completely confidential and not shared with anyone outside of the Research Team.  
 
9.3. BENEFITS 
The potential benefits of carefully monitoring youth to control their activity level and better follow 
the protocols for restricted activity is that youth and their families will be better informed about 
their concussion symptoms and level of activity. Close monitoring will also alert the family, the 
youth, school and the Research Team of any concerning symptoms and need for intervention. 
Adhering to the RTS/RTA protocols may help prevent the youth from returning to activity before 
they are ready, and this can help to prevent further injury to a vulnerable recovering brain. 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
15
9.4. STUDY WITHDRAWAL  
Participants can withdraw from this study at any time. They may contact the Principle 
Investigator/Research Coordinator to let them know they wish to no longer participate. 
Participants will be made aware that they can withdraw at any time and there will be no 
negative consequences. Immediately following study withdrawal, participants in The App 
group will be directed to unpair the watch from their personal phone if used and remove the 
App. Study equipment (phone, watch) will be returned by the participant either by provided 
Fedex postage or drop off at The McMaster Institute for Applied Health Sciences.  
 
9.5. DATA ANALYSIS PLAN 
The recordings of online consent (Zoom), for Phase 3, will be stored on a study computer 
and saved to a secure password encrypted server. As described above, participants will be 
asked to complete the (SUS). The SUS yields a single number representing a composite 
measure of the overall usability of the system being studied. Adjustments and 
modifications to The Back2Play App will be made before commercializing the product. 
    
We will collect and report descriptively all demographic information, injury-related data (type, 
mechanism of injury, numbers of injuries),  youth premorbid health history. Descriptive statistics 
such as means, medians, and frequencies will be reported where appropriate. Baseline 
comparisons will be performed between those that use The App and those whose recovery 
involved Usual Care with variables of mechanism of injury, age, sex, school performance and 
concussion history. These variables will be analyzed using Pearson Chi Squared Cross 
Tabulations, T-Test and ANCOVA, to ensure the groups are similar. We will also evaluate 
agreement of the algorithm with the self-reported stage of recovery participants input using these 
same statistics.  
 
The dichotomous variable, repeat injuries (coded as yes or no), will be analyzed using 
multivariate logistic regression and resulting odds ratios to determine if using The Back2Play 
App decreases risk of repeat injury. Confounders of age, gender, number of symptoms, time 
since last injury and comorbidities of premorbid mental health issues or learning disabilities will 
be examined as to their potential impact on outcomes. Many of these variables will be correlated 
with each other and these correlations will need to be examined carefully before they are entered 
into the analyses. 
 
Time to symptom resolution will be analyzed using survival curves with Multivariate Cox 
regression analysis. Cox regression (also called proportional hazard models) is a method of 
survival analysis that models the time until some event as a function of either continuous or 
categorical predictors, allowing for the fact that not all subjects will experience the events of 
interest and that they will occur at different times. 
 
 
9.6. DATA STORAGE AND SECURITY  
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
16
Physical files are stored in the locked cabinets in CanChild (IAHS 408) with keys only held by 3 
research staff. Computers for this project are located in CanChild. A username and password are 
required for access onto the computers/network and study specific documents are further restricted 
to the study team. Access to all data would require a data log to be completed. The Secure Network 
belongs to McMaster University and stored in a tier 4 data facility. The data centre is physically 
located in Hamilton, ON. Hamilton Health Sciences and McMaster University provides physical 
building security employing a card access system. There is a Cisco ASA Firewall in place. The 
server is running Windows 2008 R2 version. Any data from surveys will be completed online, 
deidentified, and stored onto REDCAP (https://canchild.mcmaster.ca/). REDCap (Research 
Electronic Data Capture) is a secure web application for building and managing online surveys 
and databases (www.project-redcap.org). As in several Canadian pediatric academic centers, 
REDCap has been set up in CanChild Centre for Childhood Disability Research at McMaster 
University to support research. Data is stored on a secure, firewall protected server with regular 
backup in the Faculty of Health Sciences Computer Services Unit with only the https port available 
to the internet. Data can be entered by designated users or survey respondents from any computer 
with an internet connection. Data will be anonymized upon entry and stored for 10 years.  
All data collected by The Back2Play App is stored locally on an anonymized relational database 
through McMaster’s Research and High Performance Computing Service. The data will be 
analyzed within this database and downloaded to study computers by the research staff all in de-
identified form. All Personal Health Information will be stored within a REDCAP form which will 
be separate from all participant devices and the App database. For example, the participant would 
not use their name as an identifier but would be given a code assigned by the research staff. 
  
Devices loaned by CanChild have a password that is shared with the user to prevent easy access 
to the device if it is misplaced. Users who are given a study phone and watch do not need to use 
personal data as the devices are set up and paired using an apple id that is associated with the study, 
not the user. No personal information is collected by the watch or phone. When users pair their 
personal iPhone with a study Apple watch, personal data is shared between the devices (Health 
Kit, texts, pictures etc.). Users are instructed to unpair their phone from the watch prior to 
returning, thus erasing all personal data. If they forget and cannot be contacted to do this remotely 
the watch will be unlocked by Apple and the study team will unpair and reset the watch to factory 
settings.  
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
17
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References 
 
1. 
McCrory P, Meeuwisse W, Dvroak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy 
D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, 
Federmann-Demont N, Giza CC, et al: Consensus statement on concussion in sport – the 
5th international conference on concussion in sport held in Berlin, October 2016. 
2. 
CanChild Centre for Childhood Disability Research. Return to Activity and Return 
to School Guidelines for Children and Youth with Concussion. Retrieved October 
2018; https://canchild.ca/en/resources/249-concussion-mild-traumatic-brain-injury-
guideline- brochures 
3. 
DeMatteo C, Lin CY, Foster G, Giglia L, Thabane L, Claridge E, Noseworthy M, Hall 
G, Connolly J. Evaluating Adherence to Return to School and Activity Protocols in 
Children Following. Concussion Clinical Journal Sports Medicine. 2018 (accepted, in-
press). 
4. 
DeMatteo C, Hucal M, Trimm Z. Amateur Sport Strategy - Research project. Funded 
by Hamilton Community Foundation. 2017-2019. 
5. 
Davis GA, Anderson V, Babl FE, et al. What is the difference in concussion 
management in children as compared with adults ? A systematic review. Br J Sports 
Med. 2017:1-12. doi:10.1136/bjsports-2016-097415. 
6. 
McLeod TCV, Lewis JH, Whelihan K, Bacon CEW. Rest and Return to Activity 
After Sport-Related Concussion: A Systematic Review of the Literature. J Athl 
Train. 2017;52(3):262-287. doi:10.4085/1052-6050-51.6.06. 
7. 
Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of Strict Rest 
After 
Acute 
Concussion: 
A 
Randomized 
Controlled 
Trial. 
Pediatrics. 
2015;135(2):213- 223. doi:10.1542/peds.2014-0966. 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
18
8. 
Leddy JJ, Baker JG, Willer B. Active Rehabilitation of Concussion and Post-
concussion Syndrome. Phys Med Rehabil Clin N Am. 2016;27(2):437-454. 
doi:10.1016/j.pmr.2015.12.003. 
9. 
Maerlender A, Rieman W, Lichtenstein J, Condiracci C. Programmed physical exertion 
in recovery from sports-related concussion: A randomized pilot study. Dev 
Neuropsychol. 2015;40(5):273-278. doi:10.1080/87565641.2015.1067706. 
10. 
McCloud, TC., Leach, C. Psychometric properties of self-report concussion scales 
and checklists. J Athl Train. 2012;47(2):221-3. 
11. 
Public Health Agency of Canada. Head Injuries in Children and Youth: The Invisible 
Epidemic. http://infobase.phac-aspc.gc.ca/datalab/head-injuries-blog-en.html. 
Published 2016. Accessed June 20, 2017. 
12. 
McFaull S, Subaskaran J, Branchard B, Thompson W. Emergency Department 
Surveillance of Injuries and Head Injuries Associated with Baseball, Football, Soccer 
and Ice Hockey, Children and Youth, Ages 5 to 18 Years, 2004 to 2014. Health 
Promot Chronic Dis Prev Can. 2016; 36(1): 13-4. 
13. 
Echlin PS, Tator, CH, Cusimano MD, et al. A prospective study of physician observed 
concussions during ice hockey: implications for incidence rates. Neurosurg Focus. 
2010; 29(5):E4 
14. 
Reddy CC, Collins MW, Gioia GA. Adolescent sports concussion. Phys Med Rehabil. 
2008;19(2): 247-269. 
15. 
Yeates KO, Taylor HG, Rusin J, et al. Longitudinal trajectories of postconcussive 
symptoms in children with mild traumatic brain injuries and their relationship to 
acute clinical status. Pediatrics. 2009;123:735-743. 
16. 
Lumba-Brown A, Yeates K, Sarmiento K, Breiding M, Haegerich T, Gioia G, et al 
Centers for Disease Control and Prevention Guideline on the Diagnosis and 
Management of Mild Traumatic Brain Injury Among Children. JAMA Pediatrics 
2018;Epub Ahead of Print. 
17. 
Barlow KM, Crawford S, Stevenson A, Sandhu SS, Belanger F. Epidemiology of post 
concussion syndrome in pediatric mild traumatic brain injury. Pediatrics. 
2010;126:374- 381. 
18. 
Zemek R, Barrowman N, Freedman SB, et al. Clinical Risk Score for Persistent 
Postconcussion Symptoms Among Children With Acute Concussion in the ED. 
Jama. 2016;315(10):1014-1025. doi:10.1001/jama.2016.1203. 
19. 
Arbogast KB, McGinley AD, Master CL, Grady MF, Robinson RL, & Zonfrillo 
MR. Cognitive Rest and School-Based Recommendations Following Pediatric 
Concussion: The Need for Primary Care Support Tools. Clinical pediatrics. 
2013;52(5):397-402. 
20. 
Swaine BR, Tremblay C, Platt RW, Grimard G, Zhang X, Pless IB. Previous head injury 
is risk factor for subsequent head injury in children: a longitudinal cohort study. 
Pediatrics. 2007;119:749-758. 
21. 
Buzzini SRR, Guskiewicz KM. Sport-related concussion in the young athlete. Curr 
Opin Pediatr. 2006;18(4):376-382. 
22. 
Purcell LK, Canadian Paediatric Society's Healthy Active Living and Sports 
Medicine Committee. Evaluation and management of children and adolescents with 
sports-related concussion. Paediatr Child Health. 2012;17(1):31. 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
19
23. 
Guskiewicz KM, Marshall SW, Bailes J, McCrea M, Harding HP, Matthews A, Mihalik 
JR, Cantu RC. Recurrent concussion and risk of depression in retired professional 
football players. Med Sci Sports Exerc. 2007;39(6):903-9. 
24. 
Schatz P, Moser R, Covassin T, Karpf R. Early indicators of enduring symptoms in 
high school athletes with multiple previous concussions. Neurosurgery, 2011; 
68(6):1562-7 
25. 
Brooks BL, McKay CD, Mrazik M, Barlow KM, Meeuwisse WH, Emery CA. 
Subjective, but not Objective, Lingering Effects of Multiple Past Concussions In 
Adolescents. J Neurotrauma. 2013;30(17):1469-75. 
26. 
Ganeslaingam K, Yeates KO, Taylor HG, Walz NC, Stancin T, Wade S. Executive 
functions and social competence in young children 6 months following traumatic 
brain injury. Neuropsychology. 2011;25(4): 466-476. 
27. 
Jorge RE, Starkstein SE. Pathophysiologic aspects of major depression following 
traumatic brain injury. J Head Trauma Rehabil, 2005(6):475-487. 
28. 
DeMatteo C, Hanna S, Yousefi-Nooraie R, Lin CY, Mahoney W, Law M, McCauley 
D. Quality-of-life after brain injury in childhood: time, not severity, is the significant 
factor. Brain Injury. 2014;28(1):114-21. doi: 10.3109/02699052.2013.848380. 
29. 
Giza CC, Stewart W, Prins ML.Building Good Policy From Good Science-The Case 
for Concussion and Chronic Traumatic Encephalopathy. JAMA Pediatr. 
2018;172(9):803- 804. 
30. 
Hornbeck K, Walter K, Myrvik M. Should Potential Risk of Chronic Traumatic 
Encephalopathy Be Discussed with Young Athletes? JAMA J Ethics. 2017;19(7):686-
692. doi: 10.1001/journalofethics.2017.19.7.pfor1-1707. 
31. 
McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, 
Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis G, 
Ellenbogen RG,Guskiewicz K, Herring S, Iverson GL, Jordan BD, Kissick J, McCrea 
M, McIntosh SMaddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator 
CH, Turner M.Consensus statement on concussion in sport: the 4th International 
Conference on Concussion in Sport held in Zurich, November 2012. British Journal of 
Sports Medicine. 2013;47(5):250–258. 
32. 
Meehan WP, Taylor AM, Proctor M. The Pediatric Athlete: Younger Athletes with 
Sport- Related Concussion. Clinics in Sports Medicine. 2011;30[1], 133-144. 
33. 
Buzzini SRR, Guskiewicz KM. Sport-related concussion in the young athlete. Curr 
Opin Pediatr. 2006;18(4):376-382. 
34. 
Purcell L. What are the most appropriate return-to-play guidelines for concussed 
child athletes? Br J Sports Med. 2009;43(Suppl 1):i51-i55. 
35. 
DeMatteo C, McCauley D, Stazyk K, Harper J, Adamich J, Randall S, & Missiuna, 
C: Post-concussion return to play and return to school guidelines for children and 
youth: a scoping methodology Disabil Rehabil. 2015; 37(12)1107-12. 
36. 
DeMatteo C, Stazyk K, Giglia L, Mahoney W, Singh SK, Hollenberg R, Harper JA, 
Missiuna C, Law M, McCauley D, Randall S: A balanced protocol for return to school 
for children and youth following concussive injury. Clin Pediatr (Phila). 2015 
Jul;54(8):783- 92 
37. 
DeMatteo C, Stazyk K, Singh S, Giglia L, Hollenberg R, Malcolmson C, Mahoney 
W, Harper J, Missiuna C, Law M, McCauley D. Development of a Conservative 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
20
Protocol to Return Children and Youth to Activity Following Concussive Injury. Clin 
Pedia. 2015; 54(2):152-163. 
38. 
Davis, GA, Anderson V, Babi FE, Gioia G, Giza CC, Meehan W, Scolaro Moser R, et 
al.: What is the difference in concussion management in children as compared with 
adults? A systematic review Br J Sports Med. 2017;51(12):949-957 
39. 
Sandhu H, Wilson K, Reed N, Mihailidis A. A mobile phone app for the self-
management of pediatric concussion: Development and usability testing. JMIR Human 
Factors. 2019;6(2), e12135.  
40. 
Worthen-Chaudhari L, McGonigal J, Logan K, Bockbrader MA, Yeates KO, & Mysiw 
WJ. Reducing concussion symptoms among teenage youth: Evaluation of a mobile health 
app. Brain injury, 2017;31(10), 1279-1286. 
41. 
Dexheimer JW., Kurowski BG, Anders SH, McClanahan N, Wade SL, & Babcock L. 
Usability evaluation of the SMART application for youth with mTBI. International 
journal of medical informatics, 2017;97, 163-170. 
42. 
Babcock L, Kurowski BG, Zhang N, Dexheimer, JW, Dyas J, Wade, SL. Adolescents 
with Mild Traumatic Brain Injury Get SMART: An Analysis of a Novel Web-Based 
Intervention. Telemedicine journal and e-health: the official journal of the American 
Telemedicine Association, 2017;23(7), 600-607. 
43. 
Kurowski BG, Wade S, Dexheimer JW, Dyas J, Zhang N, Babcock L. Feasibility and 
potential benefits of a web-based intervention delivered acutely after mild traumatic brain 
injury in adolescents: a pilot study. The Journal of head trauma rehabilitation, 2016; 
31(6), 369. 
44. 
Dykes PC, Stade D, Chang F, Dalal A, Getty G, Kandala R, Lee J, Lehman L, Leone K, 
Massaro AF, Milone M, McNally K, Ohashi K, Robbins K, Bates DW, Collins S. 
Participatory Design and Development of a Patient-centred Toolkit to Engage 
Hospitalized Patients and Care Partners in their Plan of Care. AMIA Annu Symp Proc, 
2014; 486-495. 
45. 
Howell DR, Osternig LR, Koester MC, Chou L-S. The effect of cognitive task complexity 
on gait stability in adolescents following concussion. Exp. Brain Res. 2014;232(6), 1773– 
1782. 
46. 
Bastien JM. Usability testing: a review of some of the methodological and technical 
aspects of the method. Int J Med Inform, 2019;79(4), e18-23.  
47. 
Goodman E, Juniavsky M, Moed A. (2012). Observing the User Experience: A 
Practitioner’s Guide to User Research. Waltham, MA: Elvesier Inc 
48. 
DeMatteo C, C.A. Yin, Foster, G., Giglia L., Thabane L., Claridge E., Noseworthy M.D., 
Hall G.B., Connolly J.F. Evaluating Adherence to Return to School and Return to 
Activity Protocols in Children After Concussion. Clinical Journal of Sports Medicine. 
2019 Dec 24. doi: 10.1097/JSM.0000000000000800 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
21
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 1.1 
Business Rules for In-App Notifications 
 
 
Progression through the CanChild RTA/RTS Guideline  
 
1. Participants cannot enter RTA Stage 4 until they have completed RTS Stage 1-3 
o If the participant reports RTA Stage 4 when they are in RTS Stage 1 or 2 they will 
receive the message “Stage 1, 2 and 3 come before RTA Stage 4!” 
 
2. Participants must complete RTS Stage 5 (Full Return to School) before they can enter RTA 
Stage 4. 
If the participant reports RTA Stage 4 or 5 when they are in RTS Stage 3 through 5, they will 
receive the message “You should complete RTS Stage 4-5 before RTA Stage 4-6”. 
 
3. Participants will be recommended to move to Stage 2 of RTS after 7 days 
o If the participant reports RTS Stage 1 for 7 days, they will receive the message “You 
reported being in Stage 1 for 1 week, time to move to Stage 2!” 
 
4. Participants will be recommended to move to Stage 3 of RTS after 14 days 
o If the participant reports RTS Stage 2 for 14 days, they will receive the message “You 
reported being in Stage 2 for 2 weeks, time to move to Stage 3!” 
 
5. Once in RTS Stage 3, participants cannot move back to Stage 2. 
o If the participant reports RTS Stage 3 and moves back to RTS Stage 2, they will receive 
the message “Once your reach RTS Stage 3, you should not return to RTS Stage 2”. 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
22
 
6. Participants are recommended to complete RTA and RTS Stage 1-3 together. 
o If the participant reports RTA Stage 3 while in RTS Stage 1 or 2, they will receive the 
message “Remember, RTS and RTA Stage 1 to 3 should go together!” 
 
7. Participants will be cautioned when they try and skip a stage  
o If the participant skips from RTS Stage 2 to RTS Stage 4, they will receive the message 
“You forgot RTS Stage 3, we recommend you log this stage first!” 
 
8. Participants will be cautioned when they try to move back a stage. 
o If the participant moves back a Stage i.e., RTS Stage 5 to Stage 4, RTA 5 to Stage 4 they 
will receive the message “Are you sure you want to move back a stage?” 
 
9. Participants cannot progress to a new stage of RTA/RTS if 2 or more symptoms worsen  
o 
If the participant reports that 2 or more symptoms worsen (from morning to evening 
survey), and the participant attempts to progress to a new stage, they will receive the 
message “We recommend you do not progress to a new stage and inform a parent of your symptoms”. 
 
10. Participants cannot progress to a new stage of RTA/RTS if their total number of symptoms 
increases by 2.  
o 
If the participant reports an increase in symptoms by 2 (from morning to evening survey) 
and the participant attempts to progress to a new stage, they will receive the message 
“We recommend you do not progress to a new stage and inform a parent of your symptom”.  
 
 
CanChild RTA/RTS Symptom Strata  
 
11. Participants will be classified to Strata A (Symptom Free within 48 hours after Injury) if their 
initial symptoms disappear within 24 hours or after 24-48 hours a participant reports < 2 
symptoms. 
o If symptoms worsen, a participant can transition to Strata B. 
o If the participant reports that their symptoms disappear within 24 hours, they will 
receive the message “Take at least 24 hours for each Stage as you complete the 
guidelines”.  
 
 
12.  Participants will be classified to Strata B (Symptom Free/Symptoms decreases within 1-4 
weeks post injury) if the report > 2 initial symptoms at 50 hours and continue at > 2 for 1 
week (168 hours) up to 4 weeks. If the child’s symptoms decrease, but are still >2, the child 
should remain in stratum B.  
o Once a participant is in Strata B, they can never go to Strata A. 
o If a participant is in Strata B and progressing through Stages within 2 days, but 
symptoms are getting worse, the child should take longer to progress through the 
stages. 
o If > 2 Symptoms for a month, move the participant to Strata C 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
23
o Recommendation: “Take at least 48 hours for each Stage as you complete the 
guidelines”.  
 
13. Participants will be classified to Strata C (Symptomatic for more than 4 weeks) if they report 
> 2 initial symptoms for > 4 weeks, or if the participant has been in Strata B for 1 month. 
o Once a participant is in Strata C, they can never go to Strata A or B. 
o Recommendation: “Take at least 1 week for each Stage as you complete the 
guidelines”.  
 
Increasing or Worsening Symptoms 
 
14. Participants will be reminded to share their symptoms with their parents if their number of 
symptoms increases by 2  
o 
If the participant reports 2 or more symptoms new symptoms, they will receive the 
message “We recommend you inform a parent of your symptoms”. 
 
15. Participants will be reminded to share their symptoms with their parents if 2 or more 
symptoms worsen.  
o 
If the participant reports 2 or more symptoms worsen, hey will receive the message “We 
recommend you inform a parent of your symptoms”. 
 
16. Participants will be recommended to slow down if their number of symptoms increases by 2 
o  If the participant reports >=2 symptoms are reported worse at all 3 surveys (3x in one 
day), they will receive the message “Slow down! Take a rest”. 
 
17. Participants will be provided positive feedback if their number of symptoms increases by 2 
o If the participant reported >=2 Symptoms logged Better, they will receive the message 
“Symptoms got better, Great job!” 
 
Activity Recommendations 
 
18. Participants will be recommended to reduce their activity if they exceed the following cut 
points: 
- 
RTA Stage 1: 5 mins of light activity  
- 
RTA Stage 2: 60 mins of light activity 
- 
RTA Stage 3: 120 mins of moderate activity  
- 
RTA Stage 4: up to180 mins of vigorous activity 
- 
RTA Stage 5: Unlimited activity *No Contact 
- 
RTA Stage 6: Unlimited *Contact 
o Light activity < 40 steps per minute (Stage 1-2) 
o Moderate activity 40-93 steps per minute (Stage 3) 
o MVPA >= 94 steps per minute (Stage 4) 
o Vigorous (Stage 5-6) doesn’t need to be distinguished 
▪ If the participant exceeds activity recommendations for RTA Stage 1 to 4 
and symptoms increase, they will receive the message “Slow down!” 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
24
▪ If the participant exceeds activity recommendations for RTA, they will 
receive the message “You did a lot of activity today!” 
▪ If the participant meets activity recommendations for RTA Stage 1 to 4, 
they will receive the message “Great job today!” 
 
19. Participants will be cautioned to reduce their activity if their heart rate exceeds 180 bpm  
o If a child exceeds 180 bpm, the Back2Play App sends a cautionary they will receive the 
message “You are doing too much!” 
o If the participant within Stage 1-3 and HR exceeds 180 bpm more than once within an 
hour, second notification is sent up to 3 notifications/day.   
 
HR, bpm 
Excepted  
If exceeds, send Notifications 
Resting 
70-85 
100 
Peak  
180 
>180 
 
 
 
 
 
 
 
Appendix 1.2 
In-App Surveys 
 
Morning Assessments 
MidDay 
Assessments  
Evening Assessments 
Stage 1- First assessment   
Post-Concussion Symptom Scale 
(Modified for App and hereon called 
Initial Symptom Survey) 
 
“How are you feeling this morning? Are 
you experiencing…” 
1. A headache: Y/N? 
2. Nausea: Y/N? 
3. Balance Problems: Y/N? 
4. Dizziness: Y/N? 
5. Fatigue: Y/N? 
6. Drowsiness: Y/N? 
7. Sensitivity to light: Y/N? 
8. Sensitivity to noise: Y/N? 
9. Irritability: Y/N? 
10. Sadness: Y/N? 
11. Nervousness: Y/N? 
12. Feeling more emotional: Y/N? 
13. Feeling Slowed down: Y/N? 
14. Mentally foggy: Y/N? 
Global: “How are you doing 
today?” question. If response 
is “Bad” present symptom 
survey.  
 
“Please select what cognitive 
activities you have been 
doing today” 
1. Socialize with friends 
2. Talk on the phone  
3. Text friends 
4. Watch a short 
video/T.V. 
5. Rest in bed 
6. Light Reading  
7. Other 
 
 
 
 
Cognitive Scale:  
“Please rate 1-5 what you’ve been doing today” 
6- None- No reading, homework, text messaging 
or screen time (T.V., cell phone), can talk on 
phone 
7- Minimal- 15 minutes of screen time or 
schoolwork 2x daily. Socialize with 1-2 
friends, no longer than 30 minutes, 
8- Moderate- Homework in 15 minutes blocks for 
a maximum of 45 minutes. Screen time/T. V in 
15-minute blocks, for up to an hour daily.  
9- High- Complete as much homework as 
tolerated. 1 test/week or tests with 
accommodation (i.e. longer time to write), less 
reading, homework and screen time than 
normal 
10- Full- no restrictions to cognitive activity 
 
“Please select what physical activities you have done 
today” 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
25
15. Difficulty concentrating: Y/N? 
16. Difficulty remembering: Y/N? 
17. Visual problems: Y/N? 
18. Confusion with directions/tasks: 
Y/N? 
19. Move in a clumsy manner: Y/N? 
20. Answer questions more slowly than 
usual: Y/N? 
21. Neck pain: Y/N? 
22. Trouble sleeping: Y/N? 
 
“What Stage of the RTS protocol are 
you in? Select: 1, 2, 3, 4, 5” 
 
“What Stage of the RTA protocol are 
you in? Select: 1, 2, 3, 4, 5” 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Get up and dressed 
2. Chores/Housework 
3. Going for a walk outdoors 
4. Other  
 
“Daily Symptom survey” 
 
 
 
 
 
 
 
 
 
Stage Two  
Daily Symptom survey  
Page 1: Current symptoms  
- 
App generates what was 
reported yesterday 
- 
Global “How are you” question 
Page 2: New Symptoms 
“Please select what cognitive 
activities you have been 
doing today” 
1- School work  
2- Computer time 
3- Socialize with friends 
4- Text/phone friends  
5- Watch video or tv 
6- Play a video game  
7- Play a board game 
8- Read a book  
9- Puzzles 
10- Other  
 
“Please rate 1-5 what you’ve been doing today” 
Cognitive Scale 
 
“What Stage of the RTS protocol are you in? Select: 
1, 2, 3, 4, 5” 
 
“What Stage of the RTA protocol are you in? Select: 
1, 2, 3, 4, 5” 
 
“What physical activities did you do today?” 
1. Brisk Walk 
2. Swim 
3. Stretch/Yoga 
4. Play Catch 
5. Walk around the mall/grocery store 
6. Walk to the bus/car 
7. Move around/clean your room 
8. Other  
 
“Daily Symptom survey” 
 
Stage Three 
Daily Symptom survey  
Page 1: Current symptoms  
- 
App generates what was 
reported yesterday 
“Please select what cognitive 
activities you have been 
doing today” 
1. School work  
“Please rate 1-5 what you’ve been doing today” 
Cognitive Scale  
“What Stage of the RTS protocol are you in? Select: 
1, 2, 3, 4, 5” 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
26
- 
Global “How are you” question 
Page 2: New Symptoms  
2. Socialize with friends 
3. Text/phone friends  
4. Use iPhone Apps i.e. 
Snapchat 
5. Play on the iPad 
6. Watch T.V. 
7. Watch a YouTube 
video 
8. Watch a movie 
9. Play video games  
10. Play a board game 
11. Read/Re-read a book  
12. Listen to music  
13. Puzzles 
14. Other  
 
 
“What Stage of the RTA protocol are you in? Select: 
1, 2, 3, 4, 5” 
  
“What physical activities did you do today?” 
1. Walk 
2. Jog 
3. Bike 
4. Hike 
5. Swim 
6. Stretch/Yoga 
7. Skate 
8. Play Catch 
9. Passing, shooting drills 
10. Dribbling/Stickhandling  
11. Other 
“Daily Symptom survey” 
 
Daily Symptom survey  
Page 1: Current symptoms  
- 
App generates what was 
reported yesterday 
- 
Global “How are you” question 
Page 2: New Symptoms  
“Please select what cognitive 
activities you have been 
doing today” 
1. School work  
2. Test/Quiz 
3. Study 
4. Socialize with friends 
5. Text/phone friends  
6. Use iPhone Apps i.e. 
Snapchat 
7. Play on the iPad 
8. Watch T.V. 
9. Watch a YouTube video 
10. Watch a movie  
11. Play video games  
12. Play a board game 
13. Read/Re-read a book  
14. Listen to music  
15. Puzzles 
16. Other  
 
“Please rate 1-5 what you’ve been doing today” 
Cognitive Scale  
 “What Stage of the RTS protocol are you in? Select: 
1, 2, 3, 4, 5” 
 
“What Stage of the RTA protocol are you in? Select: 
1, 2, 3, 4, 5” 
  
“What physical activities did you do today?” 
1. Jog 
2. Bike 
3. Hike 
4. Swim 
5. Stretch/Yoga 
6. Skate 
7. Play Catch 
8. Passing, shooting drills 
9. Dribbling/Stickhandling  
10. Throwing/Passing drills 
11. Sports-specific drills  
12. Basketball 
13. Soccer 
14. Football 
15. Hockey 
16. Rugby 
17. Resistance training  
18. Track and Field  
19. Squash/Tennis 
20. Other 
 
“Daily Symptom survey” 
Stage Five 

 
 
 
 
 
 
 
 
 
 
Back2Play App: Protocol Version 3 June 1 2022 
 
27
Daily Symptom survey  
Page 1: Current symptoms  
- 
App generates what was 
reported yesterday 
- 
Global “How are you” question 
Page 2: New Symptoms  
“Please select what cognitive 
activities you have been 
doing today” 
1. School work  
2. Test/Quiz 
3. Study 
4. Socialize with friends 
5. Text/phone friends  
6. Use iPhone Apps i.e. 
Snapchat 
7. Play on the iPad 
8. Watch T.V. 
9. Watch YouTube 
videos 
10. Watch a movie  
11. Play video games  
12. Play a board game 
13. Read/Re-read a book  
14. Listen to music  
15. Puzzles 
16. Other  
 
“Please rate 1-5 what you’ve been doing today” 
Cognitive Scale 
“What Stage of the RTS protocol are you in? Select: 
1, 2, 3, 4, 5” 
 
“What Stage of the RTA protocol are you in? Select: 
1, 2, 3, 4, 5” 
  
“What physical activities did you do today?” 
1. Run 
2. Jog 
3. Bike 
4. Hike 
5. Swim 
6. Stretch/Yoga 
7. Skate 
8. Play Catch 
9. Jumping jacks/Burpees 
10. Passing, shooting drills 
11. Dribbling/Stickhandling  
12. Throwing/Passing drills 
13. Sports-specific drills  
14. Basketball 
15. Soccer 
16. Football 
17. Hockey 
18. Rugby 
19. Resistance training  
20. Track and Field  
21. Squash/Tennis 
22. Other 
 
“Daily Symptom survey” 
 

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
1
           Appendix 1.3 
Back2Play App Visuals 
 
 
 
Figure 1. App Home 
 

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
2
 
 
Figure 2. Pop-Up Email 
 
 
 
Figure 3. Charts Page 

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
3
 
  
Appendix 1.4 
 
  
Contact form 
 
Consent to Contact: 
Participant Name/Age 
Parent/Guardian- Name & 
relationship 
Program or Setting obtaining 
consent to contact/Staff 
name 
Notes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
4
 
  
Appendix 1.5  
 
  
System Usability Scale (SUS) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
5
 
Appendix 1.6  
 
  
Follow Up Interview 
 
Ask Everyone: 
 
Tell me about where you are in recovery from your concussion. 
 
Prompts: 
Are you still experiencing any symptoms? 
 
Did you hit your head again during your recovery? 
 
If yes did it increase symptoms and how did it affect your recovery? 
 
Are you back fully to school and sport? 
 
Do you feel back to your previous self? 
 
Are there any other therapies or treatments that you tried during your recovery from concussion? 
 
Prompts: 
Medications, physio, chiro, other medical professionals 
 
Ask App users: 
 
Tell me about your experience in using the App during your recovery from concussion. 
 
Follow Up questions: 
 
Did you receive notifications from the App-give me some examples 
 
Did you do the surveys on your watch or phone? 
 
Did you ever use data or mostly Wi-Fi? 
 
Did you ever forget to charge the watch? How often? 
 
Did you agree with the guidance you were given re: activity or stage levels? (%) 
 
Did you find the App helpful at all in your recovery-how so? 
 
Did you like the App? 
 
 
Follow up questions: 
 
What were the best features of the App 
Were there features you didn’t use that much 
 
Were there things that you didn’t like or found annoying 
 
How could we make it better? 
 
Ask Usual care group 
 
What was involved in your care and follow up with your concussion? 
Were you given some sort of guidelines to follow to return to play and school? 
What format were they in? 
Did you seek extra treatment or help? 
Did you feel you understood how to get better and get back to activities and school after your 
concussion?

 
 
 
 
 
 
 
 
 
 
C. DeMATTEO, 2022 
Version 2 March 2022 
 
6