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Bootle Blast: Pilot Randomized Controlled Trial

RecruitingNAAges 6 Years - 17 YearsAllHolland Bloorview Kids Rehabilitation Hospital
NCT07289360 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Bootle Blast Intervention
  • Standard Care (Comparator)
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Where

3 sites
Grandview Kids
Ajax, Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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