NCT07289360 Bootle Blast: Pilot Randomized Controlled Trial
| NCT ID | NCT07289360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-12-06 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2025-12-06 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of hemiplegic Cerebral Palsy * MACS levels I (handles objects easily) to III (handles objects with difficulty) * Aged 6 to 17 years with sufficient cognitive capacity and cooperation to play Bootle Blast and complete outcome assessments * Ability to communicate in English * Able to travel to Holland Bloorview, Grandview or CHEO and complete a total of 3 in-person study appointments * Has a large screen (e.g. TV) with an appropriate play space (3m x 3m) in front * At least intermittent access to the internet * Have time to play Bootle Blast for 15-20 minutes/day, 3-4 days/week for 12 weeks. Exclusion Criteria: * Received upper limb surgery, botulin toxin injections in the past 4 months, or constraint therapy/casting in the previous 3 months that may be associated with changing abilities * Currently or anticipates receiving active treatments impacting upper limb function during the study period * Uncontrolled epilepsy that may be triggered by video game play * Medical condition impeding safe participation in physical activity associated with Bootle Blast * Visual limitations that interfere with Bootle Blast play
Contact & Investigator
Elaine Biddiss, PhD
PRINCIPAL INVESTIGATOR
Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute
Frequently Asked Questions
Who can join the NCT07289360 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07289360 currently recruiting?
Yes, NCT07289360 is actively recruiting participants. Contact the research team at ssert@hollandbloorview.ca for enrollment information.
Where is the NCT07289360 trial being conducted?
This trial is being conducted at Ajax, Canada, Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT07289360 clinical trial?
NCT07289360 is sponsored by Holland Bloorview Kids Rehabilitation Hospital. The principal investigator is Elaine Biddiss, PhD at Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute. The trial plans to enroll 46 participants.
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