Bootle Blast: Understanding the Family Experience

NCT ID: NCT06161168

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Baseline Phase (10 or 21 days)

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).

Group Type: EXPERIMENTAL

Bootle Blast Play Phase (B)

Intervention Type: 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.

Interventions

Bootle Blast Play Phase (B)

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Biddiss, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloorview Research Institute

Locations

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Elaine Biddiss, PhD

Role: CONTACT

Phone: 416-425-6220

Email: ebiddiss@hollandbloorview.ca

Ajmal Khan, MHSc

Role: CONTACT

Phone: 416-425-6220

Email: akhan@hollandbloorview.ca

Facility Contacts

Elaine Biddiss, PhD

Role: primary

Ajmal Khan, MHSc

Role: backup

Other Identifiers

0110

Identifier Type: -

Identifier Source: org_study_id