Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161168
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-07-25
Brief Title:
Bootle Blast Understanding the Family Experience
Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Organization:
Holland Bloorview Kids Rehabilitation Hospital
Study Overview
Official Title:
Bootle Blast a Movement Tracking Video Game for Home-based Motor Therapy Understanding the Family Experience
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Canadas largest childrens 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 eg independent home setup ability to setmeet self-directed play time goals enablersbarriers 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
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 eg independent home setup ability to setmeet self-directed play time goals enablersbarriers 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 improvingmaintaining their coordination flexibility strength dexterity and function These therapies can enhance childrens 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 timesweek 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 ie structuring practices ensuring good form initiatingsustaining 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 ie 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 hrsweek As such therapy gaming is well aligned with the practice of family-centred care which favours treatments preferred by childrenTherapy gaming is also compelling from a motor learning perspective with potential for intense practice feedback individualized programs task specificity ie similarity between virtual and real-world tasks and social equalization These five features are considered the active ingredients ie reasons why a treatment is expected to be effective of video games for motor therapy
8 years ago families and clinicians at Canadas 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 ie children with disabilities siblings caregivers clinicians interdisciplinary researchers specialists eg 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 parenttherapist 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 eg 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 childs 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 eg 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 enablersbarriers 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 familiesclinicians on changes in movement characteristics eg smoothness of movement reach envelope The latter could provide families using the system at home with potentially useful information for progress tracking
Movement-tracking video games for home-based therapy practice ie 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 hrsweek As such therapy gaming is well aligned with the practice of family-centred care which favours treatments preferred by childrenTherapy gaming is also compelling from a motor learning perspective with potential for intense practice feedback individualized programs task specificity ie similarity between virtual and real-world tasks and social equalization These five features are considered the active ingredients ie reasons why a treatment is expected to be effective of video games for motor therapy
8 years ago families and clinicians at Canadas 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 ie children with disabilities siblings caregivers clinicians interdisciplinary researchers specialists eg 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 parenttherapist 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 eg 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 childs 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 eg 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 enablersbarriers 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 familiesclinicians on changes in movement characteristics eg smoothness of movement reach envelope The latter could provide families using the system at home with potentially useful information for progress tracking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None