Bootle Blast: Understanding the Family Experience

NCT06161168 | Unknown DMC

• 1 other identifier: 0110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

One in 60 children have a physical disability that can impact activities and participation. Occupational and physical therapies can be of great benefit, but are costly and difficult to access. Working with children, parents and clinicians, the investigators developed a mixed reality video game, Bootle Blast, which children can play to develop motor skills. Using a 3D sensor, Bootle Blast tracks movements and manipulation of real-life objects. Since 2017, Bootle Blast has been used in clinics by Holland Bloorview, Canada's largest children's rehabilitation hospital. Home use of Bootle Blast has resulted in positive clinical outcomes for children with cerebral palsy. Bootle Blast is not yet commercially available and has yet to be trialed in "real-world" contexts. To understand real-world implementation, Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value. User experience will inform product, training and resource development. The research team combines expertise in engineering design, medicine, physiotherapy, qualitative methods, commercialization, knowledge translation, and includes young people with lived experience.

Conditions

Cerebral Palsy; Developmental Coordination Disorder; Developmental Disability; Autism Spectrum Disorder; Spinal Cord Injuries; Stroke; Acquired Brain Injury; Motor Skills Disorders

Keywords

Hand function; Arm function; At-home rehabilitation; Trunk stability; Balance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• Rates of recruitment and attrition

  Throughout study (17 weeks)

• Family Information Demographic Form

  Following consent but prior to commencement of baseline phase (i.e. Week 0)

• The ABILHAND-Kids

  Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase

• The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)

  Day 1 of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase

• Children & Adolescent Scale of Participation (CASP)

  Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase

Study Arms (1)

Baseline Phase (10 or 21 days)

EXPERIMENTAL

In this study, participants will be randomly allocated to a baseline (A) phase that is further divided into two sub-phases, with different durations of either 10 or 21 days. The allocation to different durations of the baseline phase is randomized in order to mitigate threats to internal validity. During the baseline (A) phase, a representative baseline will be established through repeated measurements of the PQRS. Following the baseline phase (A), the 8-week intervention phase (B) is implemented, followed by a second 3-week (A) phase. There is no separate control group in this study, and all participants receive the same intervention during the intervention phase (B).

Device: Bootle Blast Play Phase (B)

Interventions

Bootle Blast Play Phase (B) DEVICE

Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value. During the 8-week intervention phase (B), children will have Bootle Blast at home and play it according to their family-directed playtime goals. Weekly logs of therapy activities and problems encountered while playing will be collected through survey links. Additionally, families will record a video of their child performing the tasks associated with their COPM goals on a weekly basis. After the 8-week intervention (B) phase, participants will enter a second 3-week baseline (A) phase, during which they'll be asked to stop playing Bootle Blast, and the game will be programmatically locked to prevent further play.

Baseline Phase (10 or 21 days)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Any motor condition that can be addressed by the Bootle Blast system;
• Interest in developing motor skills practiced in BootleBlast;
• Aged 6-17 years;
• Sufficient cognitive capacity to play BootleBlast as indicated by caregiver/self report;
• Able to communicate in English;
• Intermittent access to internet;
• Ability to participate in video calling;
• Have a device to record and upload short videos;
• Have a caregiver willing to participate.

You may not qualify if:

• Uncontrolled epilepsy triggered by video games;
• Medical condition making the physical activity in BootleBlast unsafe;
• Visual and/or hearing limitations affecting BootleBlast play;
• No access to internet at home
• Has previously participated in a study related to Bootle Blast.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Motor Skills Disorders; Developmental Disabilities; Autism Spectrum Disorder; Spinal Cord Injuries; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma

Study Officials

• Elaine Biddiss, PhD

  Bloorview Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Biddiss, PhD

CONTACT

416-425-6220; ebiddiss@hollandbloorview.ca

Ajmal Khan, MHSc

CONTACT

416-425-6220; akhan@hollandbloorview.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Assessors will be trained on practice videos prior to establish consistent scoring practices. Additionally, assessors will be blinded to the time point at which the video recording was collected. Lastly, blinded therapists will observe gameplay videos collected at the beginning and towards the end of the intervention to identify movements made, any compensatory movements observed, repetition counts, fatigue level, as well the child's overall coordination (i.e. the smooth and controlled use of movements in motor performance with consideration of timing, velocity, targeting accuracy, motor planning, directions, force and endurance).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 17 week mixed methods study with a non-blinded, randomized, multiple baseline single-case experimental design (SCED) to answer the secondary research question. The research design has two phases: a baseline phase (A) wherein a representative baseline will be established through repeated measurements of the PQRS, followed by the Bootle Blast intervention phase (B). In a randomized, multiple baseline SCED, the start of the B phase is randomized to mitigate threats to internal validity. A minimum of 3 measurements is required in each phase. In this study, participants will be randomly allocated to a baseline A phase ranging from 10 to 21 days. The B Phase will be 8 weeks followed by a second 3 week A phase. Families will retain Bootle Blast at home and will have the option to continue use of Bootle Blast in weeks 15 to 17 as desired.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: December 7, 2023
• Study Start: July 7, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)