Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT07289360

Bootle Blast: Pilot Randomized Controlled Trial

Led by Holland Bloorview Kids Rehabilitation Hospital · Updated on 2026-01-08

46

Participants Needed

3

Research Sites

55 weeks

Total Duration

On this page

Sponsors

H

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Bootle Blast: Pilot Randomized Controlled Trial

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Grandview Kids

Ajax, Ontario, Canada, L1T 0R3

Not Yet Recruiting

2

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada, K1H 8L1

Actively Recruiting

3

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada, M4G 1R8

Actively Recruiting

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Research Team

S

Selvi Research Coordinator, MEng

CONTACT

G

Gloria Research Manager, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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