Clinical trial NCT06161168: Bootle Blast: Understanding the Family Experience
Official title: Bootle Blast, a Movement Tracking Video Game for Home-based Motor Therapy: Understanding the Family Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: One in 60 Canadian children has a physical disability that impacts function, activity and participation. Physical and occupational therapies are important for improving/maintaining their coordination, flexibility, strength, dexterity and function. These therapies can enhance children's independence, education and employment opportunities, as well as leisure play and social inclusion. Therapies can also mitigate need for surgical intervention, secondary injuries and other complications that result from compensatory movements and poor conditioning as the child grows. While the benefits of therapy are significant, costs for families and the healthcare system are escalating. Demand for therapy outpaces availability. Families in rural areas may travel long distances to access services or miss out. Even when resources are available, therapy is seldom offered more than 1 or 2 times/week for 30 - 60 minutes while the literature suggests that 30 - 45 min of practice per day is necessary to drive neuroplastic change and motor learning. This underlies the need for home-based programs to increase opportunities for practice of goal-directed movements. While home-based therapy improves outcomes, nearly half of families report poor adherence due to limited time, lack of motivation, or forgetfulness. For parents, the role of "therapist at home" is associated with many challenges (i.e. structuring practices, ensuring good form, initiating/sustaining participation) and, in fact, can negatively impact parent-child relationships and elevate parental stress and burden of care. Maintaining child and parent motivation in home-based therapies is a long-standing challenge of great importance in pediatric practice. In fact, clinicians rate child motivation to be the most influential trait predicting success in motor therapies.

Movement-tracking video games for home-based therapy practice (i.e. therapy gaming) appeal to clinicians, children and parents. Video games are a popular pastime for 82% of children with disabilities and 88% of children without, with an average play time of 13 hrs/week. As such, therapy gaming is well aligned with the practice of family-centred care which favours treatments preferred by children.Therapy gaming is also compelling from a motor learning perspective with potential for intense practice, feedback, individualized programs, task specificity (i.e. similarity between virtual and real-world tasks), and social equalization. These five features are considered the "active ingredients" (i.e. reasons why a treatment is expected to be effective) of video games for motor therapy.

8 years ago, families and clinicians at Canada's largest children rehabilitation hospital, Holland Bloorview Kids Rehabilitation Hospital (Holland Bloorview), and partner organizations affiliated with Empowered Kids Ontario (EKO), asked: Can video games be used to create fun, effective opportunities for motor practice for children with CP? Finding no suitable technologies to deliver the active ingredients for motor therapy, the investigators partnered with knowledge users (i.e. children with disabilities, siblings, caregivers, clinicians), interdisciplinary researchers, specialists (e.g. engineers, games designers) and with guidance from provincial networks (CP-NET) and external partners (Toronto Innovation Acceleration Partners (TIAP), formerly MaRS Innovation; Ubisoft), developed Bootle Blast. Bootle Blast overcomes many established limitations of video games for motor therapy including: inability to target fine motor skills, solo gameplay and failure to sustain engagement without significant parent/therapist involvement. Bootle Blast is the first video game for motor therapy to apply best practices in motor learning, game design, and motivation theory. It provides high quality biofeedback and is built on a theoretical framework of engagement used in pediatric rehabilitation, as summarized in two systematic reviews the investigators generated in the research process. Using computer vision, Bootle Blast provides real-time feedback on skeletal movements and interactions with real-life objects used in gameplay (e.g. building blocks). This "mixed reality" play experience offers greater task specificity to enhance transfer of skills to everyday activities. It enables individualized treatment plans by supporting a wide range of motor skills with activities that can be calibrated to each child's abilities. Bootle Blast enables differently abled people to play together, enhancing social equalization.

Creating a product that can be successfully used at home by families as a complement to conventional therapies, as well as by those on waitlists or who no longer qualify for clinical services (e.g. children no longer considered for "early intervention"), will greatly expand the market potential of Bootle Blast.

OBJECTIVES. In this project, the investigators will conduct real-world testing to identify potential barriers to home use.

RESEARCH QUESTION: In this study, the investigators will answer the questions: Firstly, is it feasible for families to independently set-up and sustain use of Bootle Blast at home? And, secondly, does using Bootle Blast at home over 14 weeks impact perceived performance on family-identified goals? Bootle Blast will be considered feasible if: (i) \>95% of families are able to setup Bootle Blast independently with assistance provided through online or telephone technical support if needed; and (ii) \>70% of families achieve their self-identified playtime goal. The play time goal will be self-directed and inputted as part of the onboarding process. Adherence averages 70% in previous research. To answer the primary research question regarding feasibility for in-home implementation, the investigators will use mixed methods to explore challenges encountered in setting up and using Bootle Blast at home, its perceived value, and the enablers/barriers to engagement, including the types of supports desired by families. To answer the second research question regarding perceived impact, the investigators will use (i) the Canadian Occupational Performance Measure (COPM) to investigate changes in perceived performance on a family-identified primary goal associated with the Bootle Blast play and, (ii) the Performance Quality Rating Scale (PQRS). Survey and interview data will be used to provide further context. Finally, the investigators will conduct exploratory analyses into the accuracy of system-collected joint data and its potential to inform families/clinicians on changes in movement characteristics (e.g. smoothness of movement, reach envelope). The latter could provide families using the system at home with potentially useful information for progress tracking.

Eligibility criteria: Child Participant Inclusion Criteria:

* 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.

Child Participant Exclusion Criteria:

* 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: First and last day of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase
measure: Performance Quality Rating Scale (PQRS)
timeFrame: Weekly throughout study completion (14 weeks)
Secondary outcomes:
measure: Rates of recruitment and attrition
timeFrame: Throughout study (17 weeks)
measure: Family Information Demographic Form
timeFrame: Following consent but prior to commencement of baseline phase (i.e. Week 0)
measure: The ABILHAND-Kids
timeFrame: Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase
measure: The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: Day 1 of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase
measure: Children & Adolescent Scale of Participation (CASP)
timeFrame: Week 0; 8th week of Intervention Phase; 3rd week of Follow-up Phase
measure: Pre-intervention interview
timeFrame: Day 1 of Baseline Phase
measure: Observation of the device set-up: Time Required
timeFrame: Last day of Baseline Phase
measure: Observation of the device set-up: User Manual Utilization
timeFrame: Last day of Baseline Phase
measure: Observation of the device set-up: Complexity of Bootle Blast Setup Process
timeFrame: Last day of Baseline Phase
measure: Observation of the device set-up: Participant Interaction with Setup Components
timeFrame: Last day of Baseline Phase
measure: Observation of the device set-up: Onboarding Effectiveness
timeFrame: Last day of Baseline Phase
measure: Observation of the device set-up: Affective Responses
timeFrame: Last day of Baseline Phase
measure: System collected data
timeFrame: Throughout intervention phase (Week 1 - 8); Optional Phase (Week 15 - 17)
measure: Child and Adolescent Factors Inventory (CAFI)
timeFrame: Following consent but prior to commencement of baseline phase (i.e. Week 0)
measure: Access To Therapy Services Questionnaire
timeFrame: Following consent but prior to commencement of baseline phase (i.e. Week 0)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Bloorview Research Institute
name: Elaine Biddiss, PhD
role: PRINCIPAL_INVESTIGATOR
References: