Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT07289360
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bootle Blast: Pilot Randomized Controlled Trial
Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Organization:
Study Overview
Official Title:
Testing a Mixed-Reality Video Game for Home-Based Practice of Arm-Hand Skills for Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-12
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 500 Canadians has cerebral palsy (CP), a lifelong condition affecting movement and function. Physical and occupational therapies greatly benefit children with CP but can be costly and difficult to access. Children, parents, and clinicians are interested in using movement-tracking video games for home-based hand/arm therapy. Yet, the technologies and evidence to support this approach are limited. We partnered with key stakeholders and an interdisciplinary team to co-create Bootle Blast. Bootle Blast tracks skeletal movements and interactions with real-life objects, engaging children in individualized play experiences rich in feedback, task specificity, and opportunities for goal-directed motor practice linked to meaningful activities.
To establish Bootle Blast's clinical effectiveness, a large-scale randomized controlled trial (RCT) is needed. Pilot RCTs provide important insights that position large-scale RCTs for success. As a result, the goal of this Pilot RCT is to test whether a mixed-reality video game intervention (i.e. Bootle Blast) can improve upper-limb function, activity, and participation in children and youth aged 6-17 years with hemiplegic cerebral palsy. The main questions it aims to answer are: (1) Is it feasible and acceptable for families to use Bootle Blast at home for 12 weeks? (2) Does the intervention show preliminary improvements in hand-arm motor outcomes compared to usual care?
Researchers will compare an immediate Bootle Blast intervention group to a waitlist comparison group that continues usual care for 12 weeks to see whether access to Bootle Blast leads to increased practice, greater engagement, and improved motor outcomes.
Participants will:
Complete three in-person assessments (baseline, 12 weeks, 24 weeks) with standardized motor and participation measures.
Be randomized to begin 12 weeks of home-based Bootle Blast immediately or after a 12-week waitlist period.
Use the Bootle Blast game at home for 15-20 minutes per day, 3-4 days per week, with all gameplay tracked automatically.
A subset of participants will also receive weekly 10-minute support calls from a monitoring coach.
To establish Bootle Blast's clinical effectiveness, a large-scale randomized controlled trial (RCT) is needed. Pilot RCTs provide important insights that position large-scale RCTs for success. As a result, the goal of this Pilot RCT is to test whether a mixed-reality video game intervention (i.e. Bootle Blast) can improve upper-limb function, activity, and participation in children and youth aged 6-17 years with hemiplegic cerebral palsy. The main questions it aims to answer are: (1) Is it feasible and acceptable for families to use Bootle Blast at home for 12 weeks? (2) Does the intervention show preliminary improvements in hand-arm motor outcomes compared to usual care?
Researchers will compare an immediate Bootle Blast intervention group to a waitlist comparison group that continues usual care for 12 weeks to see whether access to Bootle Blast leads to increased practice, greater engagement, and improved motor outcomes.
Participants will:
Complete three in-person assessments (baseline, 12 weeks, 24 weeks) with standardized motor and participation measures.
Be randomized to begin 12 weeks of home-based Bootle Blast immediately or after a 12-week waitlist period.
Use the Bootle Blast game at home for 15-20 minutes per day, 3-4 days per week, with all gameplay tracked automatically.
A subset of participants will also receive weekly 10-minute support calls from a monitoring coach.
Detailed Description:
One in 500 Canadians has cerebral palsy (CP), a lifelong condition affecting movement and function.CP is the most common cause of physical disability in children. Hemiplegic CP (\~40% of CP diagnoses) affects one side of the body impacting arm/hand function. Between 60% and 83% of children with CP have upper limb involvement that can impact independence in activities of daily living, school and leisure, and social participation. Occupational and physiotherapy can help improve and/or maintain the many components of arm and hand function including gripping/releasing objects, reach, speed and accuracy, grip strength, and sensibility, often mitigating need for surgical interventions. While benefits of therapy can be significant, costs to the healthcare system and families are rising. Costs to manage CP over a lifetime average $1.2 million/person. Demand for therapy outpaces availability. In rural areas, families travel far to access services. While home-based therapy can improve outcomes, nearly half of families report low adherence due to limited time, lack of motivation, or forgetfulness. Sustaining child and parent motivation in home-based motor 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 for CP. There is a clear need for new approaches to motivate and support children and families in home-based therapy.
In line with this need, families and clinicians at Holland Bloorview Kids Rehabilitation Hospital (Holland Bloorview) and partner organizations affiliated with Empowered Kids Ontario (EKO), asked: can we use video games to create fun, effective opportunities for motor practice for children with CP? Finding no suitable video games to support hand/arm therapy, we partnered with diverse knowledge users (i.e. children with CP, their siblings, caregivers, clinicians), interdisciplinary researchers, specialists (e.g. engineers, games developers) and with guidance from provincial networks (CP-Net) and external partnerships (MaRS Innovation; Ubisoft), developed Bootle Blast. Bootle Blast was designed to overcome established limitations of video games currently used for hand-arm therapy including: lack of feedback, inability to target specific therapy goals and/or sustain engagement, and solo gameplay. Bootle Blast is the first video game for hand-arm therapy that systematically integrates best practices in motor learning, motivational theory, and game design. Using the Orbbec Persee (a 3D camera-computer), Bootle Blast provides real-time feedback on skeletal movements and interactions with real-life objects used in gameplay (e.g. building blocks) that is tracked over time. This "mixed reality" play experience offers greater task specificity to enhance transfer of skills to everyday activities. It enables individualized treatment plans by supporting practice of a wide range of motor skills with activities that can be calibrated to each child's abilities. Bootle Blast enables people of different abilities to play meaningfully together, enhancing social equalization. Game rewards are directly linked to therapeutic effort and incentivize frequent practice of goal-directed movements. These 5 attributes (feedback, task specificity, individualized treatment plans, social equalization, practice) are considered the system-level "active ingredients" of interactive computer play for motor learning, while therapist support is considered an intervention-level "active ingredient" that can impact participant motivation and outcomes. Bootle Blast is the first technology to deliver all five active ingredients, while also applying engaging game design principles. With support from CIHR, NSERC and the Ontario Brain Institute, Bootle Blast has been iteratively co-created and tested with the Children's Advisory Council, in clinics, and with research participants culminating in a refined technology that reflects the lived experiences of our knowledge users.
To establish the clinical effectiveness of Bootle Blast, a well-designed randomized controlled trial (RCT) is now needed. Efficacy RCTs are resource intensive. Pilot RCTs provide critical insights that position efficacy RCTs for success and help to ensure that resources are invested in trials likely to generate clinically meaningful results.
Consequently, this pilot randomized controlled trial will examine whether it is feasible and acceptable to conduct a larger RCT to determine whether 12 weeks of home-based Bootle Blast use can improve upper-limb function, activity, and participation outcomes in children with hemiplegic CP compared to standard care. The study uses a mixed-methods design with a waitlist comparison group. Children aged 6-17 years with hemiplegic CP (MACS I-III) will be randomized using minimization to balance age, sex, and MACS level. The intervention group will receive Bootle Blast immediately for 12 weeks, while the comparison group continues their usual care for 12 weeks before crossing over. A subset of participants in each arm will be randomly assigned to receive weekly support from a monitoring coach to investigate whether coach contact affects adherence, engagement, or outcomes.
In line with this need, families and clinicians at Holland Bloorview Kids Rehabilitation Hospital (Holland Bloorview) and partner organizations affiliated with Empowered Kids Ontario (EKO), asked: can we use video games to create fun, effective opportunities for motor practice for children with CP? Finding no suitable video games to support hand/arm therapy, we partnered with diverse knowledge users (i.e. children with CP, their siblings, caregivers, clinicians), interdisciplinary researchers, specialists (e.g. engineers, games developers) and with guidance from provincial networks (CP-Net) and external partnerships (MaRS Innovation; Ubisoft), developed Bootle Blast. Bootle Blast was designed to overcome established limitations of video games currently used for hand-arm therapy including: lack of feedback, inability to target specific therapy goals and/or sustain engagement, and solo gameplay. Bootle Blast is the first video game for hand-arm therapy that systematically integrates best practices in motor learning, motivational theory, and game design. Using the Orbbec Persee (a 3D camera-computer), Bootle Blast provides real-time feedback on skeletal movements and interactions with real-life objects used in gameplay (e.g. building blocks) that is tracked over time. This "mixed reality" play experience offers greater task specificity to enhance transfer of skills to everyday activities. It enables individualized treatment plans by supporting practice of a wide range of motor skills with activities that can be calibrated to each child's abilities. Bootle Blast enables people of different abilities to play meaningfully together, enhancing social equalization. Game rewards are directly linked to therapeutic effort and incentivize frequent practice of goal-directed movements. These 5 attributes (feedback, task specificity, individualized treatment plans, social equalization, practice) are considered the system-level "active ingredients" of interactive computer play for motor learning, while therapist support is considered an intervention-level "active ingredient" that can impact participant motivation and outcomes. Bootle Blast is the first technology to deliver all five active ingredients, while also applying engaging game design principles. With support from CIHR, NSERC and the Ontario Brain Institute, Bootle Blast has been iteratively co-created and tested with the Children's Advisory Council, in clinics, and with research participants culminating in a refined technology that reflects the lived experiences of our knowledge users.
To establish the clinical effectiveness of Bootle Blast, a well-designed randomized controlled trial (RCT) is now needed. Efficacy RCTs are resource intensive. Pilot RCTs provide critical insights that position efficacy RCTs for success and help to ensure that resources are invested in trials likely to generate clinically meaningful results.
Consequently, this pilot randomized controlled trial will examine whether it is feasible and acceptable to conduct a larger RCT to determine whether 12 weeks of home-based Bootle Blast use can improve upper-limb function, activity, and participation outcomes in children with hemiplegic CP compared to standard care. The study uses a mixed-methods design with a waitlist comparison group. Children aged 6-17 years with hemiplegic CP (MACS I-III) will be randomized using minimization to balance age, sex, and MACS level. The intervention group will receive Bootle Blast immediately for 12 weeks, while the comparison group continues their usual care for 12 weeks before crossing over. A subset of participants in each arm will be randomly assigned to receive weekly support from a monitoring coach to investigate whether coach contact affects adherence, engagement, or outcomes.
Study Oversight
Has Oversight DMC:
False
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?: