Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Canadian Occupational Performance Measure (COPM) |
The family will complete the Canadian Occupational Performance Measure with the interviewer to establish 1 to 3 goals related to activities of everyday living (e.g. self-care, leisure) that they hope Bootle Blast might help with. The COPM assesses self-perceived performance and satisfaction on activities of importance to child/family. Participants then rate their performance and satisfaction for each goal/challenge area on a scale from 1 to 10 (low to high). Average scores for performance and satisfaction are calculated across the goals. The COPM is extensively used with children with CP in the target age range and with success in the research team's pilot work. It has good validity, responsiveness, reliability, and ability to track change over time. A change of 2 points on either the performance or satisfaction scale is considered clinically significant. The COPM takes ~20 minutes. |
First and last day of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase |
|
Primary |
Performance Quality Rating Scale (PQRS) |
The PQRS will be used to evaluate parent-recorded videos of children performing one of their COPM each week. The PQRS is an observational, video-based tool that looks at actual performance on client-selected activities, and has been used in the context of SCED research for children with diverse diagnoses, including CP and DCD. It utilizes a 10 point scale with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. Quality takes into account, as applicable to the task, timeliness, accuracy, safety, and overall quality of performance or product. Ratings are based on average of completeness and quality. Inter-rater reliability for the PQRS is moderate ranging from 0.71-0.77. Test-retest reliability is also substantial (>0.9) across time periods and multiple raters. Assessors will be trained on practice videos to establish consistent scoring practices. Assessors will be blinded to the time point at which the video recording was collected. |
Weekly throughout study completion (14 weeks) |
|
Secondary |
Rates of recruitment and attrition |
This will inform the appropriateness of Bootle Blast to meet family's needs (e.g. interest in the system, availability of an appropriate space etc.). Reasons for non-participation will be recorded where possible. |
Throughout study (17 weeks) |
|
Secondary |
Family Information Demographic Form |
The investigators will document demographic data on participants (e.g. gender, age, diagnosis), family (e.g. family composition, socioeconomic status, access to services) and the caregiver (e.g. comfort with technology, relationship with child), including relevant functional assessments (e.g. MACS and GMFCS level for CP; Movement ABC Battery61 for DCD) for descriptive purposes and to provide context for data synthesis. This survey will be hosted on REDcap and distributed via email links prior to the pre-intervention interview with a a maximum 3 reminders to ensure questionnaire completion. Any missing data or participant questions will be reviewed in the pre-intervention interview. |
Following consent but prior to commencement of baseline phase (i.e. Week 0) |
|
Secondary |
The ABILHAND-Kids |
This will be used to describe the population in terms of level of functional ability and as an outcome measure. This questionnaire asks parents to report on their child's ability to perform 21 primarily bimanual activities on a 3 point scale (0=impossible, 1=difficult, 2=easy). The total maximum score is 42. Previous work has established its excellent test-retest reliability, inter-rater reliability, and internal consistency when completed by parents for children with CP aged 4 to 18 years. The 10 min survey has demonstrated sensitivity to change with a large effect size of 0.92 (logit change of 1.06) reported for children with CP aged 6-12 years and a moderate effect size (logit change of 0.71) for 13-19 year olds after treatments. Additionally, this questionnaire has good psychometric properties and use in a range of developmental conditions as may be included in this study. This parent-reported survey will be administered via REDCap. |
Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase |
|
Secondary |
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) |
This is a participant-reported measure of functional skills in four domains, including performance of activities of daily living, mobility, social-cognitive, and responsibility. It has been used to both quantify function and measure change following interventions. It has strong validity and reliability in diverse populations with developmental disabilities across multiple age ranges. The online questionnaire will be filled out during the pre-intervention interview via screen share with the researcher reading the questions as needed and the participant indicating their responses. The assessment takes about 12 minutes. |
Day 1 of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase |
|
Secondary |
Children & Adolescent Scale of Participation (CASP) |
The CASP consists of 20 ordinal-scaled items and four subsections: 1) Home Participation (6 items), 2) Community Participation (4 items), 3) School Participation (5 items), and 4) Home and Community Living Activities (5 items). The 20 items are rated on a four-point scale: "Age Expected (Full participation)," "Somewhat Restricted," "Very Restricted," "Unable." It can be used with children 5 years and up. The CASP has excellent test re-test reliability (Intraclass Correlation Coefficient = 0.94), internal consistency (a = 0.96) and construct and discriminant validity. The CASP will be completed by parents and by youth (>11 years) as previous research indicates that there may be differences between parent and youth reported participation. The CASP will be administered via REDCap. |
Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase |
|
Secondary |
Pre-intervention interview |
A 1 hour zoom interview will be conducted to understand each families' hopes/expectations for the Bootle Blast program and to establish the COPM goals (described below), one of which must be an activity conducive to weekly filming. During this interview, parents will be trained on how to record a video of their child performing the activity associated with one of their COPM goals and upload videos to Sync a secure cloud server (www.sync.com), as well as establish a consistent way of filming (e.g. appropriate lighting, consistent angle). To this end, the investigators will provide families with a tripod as needed to facilitate filming and may make suggestions such as marking the position where the tripod should be placed with a piece of tape, etc. This video will be used to complete the Performance Quality Rating Scale (PQRS), as described below. |
Day 1 of Baseline Phase |
|
Secondary |
Observation of the device set-up: Time Required |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of the total time taken by participants to set up the Bootle Blast from start to finish (minutes). The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
Observation of the device set-up: User Manual Utilization |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of the frequency and duration of user manual consultation during the setup process (minutes). The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
Observation of the device set-up: Complexity of Bootle Blast Setup Process |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of the main points of confusion and number of errors made during the setup as noted by the observer through qualitative descriptions. The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
Observation of the device set-up: Participant Interaction with Setup Components |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of the the process of installing the Orbbec, setting up the game space, launching the game, and the involvement of children/caregivers during the setup through qualitative descriptions and Installation Success Rate (binary: yes/no). The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
Observation of the device set-up: Onboarding Effectiveness |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of how users interact with the game guide, calibration, playtime goal setup, game navigation, playing a mini-game through qualitative descriptions and Calibration Success Rate (binary: yes/no). The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
Observation of the device set-up: Affective Responses |
Observations of the home set-up will be logged by researchers observing by video call using the observation checklist. The researcher will take note of the emotional responses of participants during the installation process through qualitative descriptions. The home set up session will be recorded via the Zoom platform. |
Last day of Baseline Phase |
|
Secondary |
System collected data |
All user activity (e.g. games played, time, skeletal joint movement data etc.) is recorded. Active (e.g. therapeutic movement) and passive (e.g. navigating menus) play time and the number of intentional therapeutic movements will be recorded. Periodically, the game will ask the player if they are having fun, if the challenge level is right, and if they are feeling tired. Video recordings collected via Bootle Blast are mostly non-identifying. The face and much of the background, are blocked to preserve privacy. Families can enable or disable video recordings which they can adjust at any time. Data will be encrypted, uploaded, and stored on Google Cloud's Firebase Realtime Database and Cloud Storage (Montreal-based server). Data are linked to the participant via a unique ID. No personal health information is collected or stored on the server. Upon study completion, participant data are removed from Google Cloud and transferred to a secure server located onsite at Holland Bloorview. |
Throughout intervention phase (Week 1 - 8); Optional Phase (Week 15 - 17) |
|
Secondary |
Child and Adolescent Factors Inventory (CAFI) |
The family will complete the CAFI to describe their child's challenges and strengths. This survey will be hosted on REDcap and distributed via email links prior to the pre-intervention interview with a a maximum 3 reminders to ensure questionnaire completion. Any missing data or participant questions will be reviewed in the pre-intervention interview. |
Following consent but prior to commencement of baseline phase (i.e. Week 0) |
|
Secondary |
Access To Therapy Services Questionnaire |
The family will complete the Access to Therapy Services questionnaire to describe their child's access to care and utilization of healthcare services. This survey will be hosted on REDcap and distributed via email links prior to the pre-intervention interview with a a maximum 3 reminders to ensure questionnaire completion. Any missing data or participant questions will be reviewed in the pre-intervention interview. |
Following consent but prior to commencement of baseline phase (i.e. Week 0) |
|