Bootle Blast: Pilot Randomized Controlled Trial

NCT07289360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy (CP)
  • Hemiplegic Cerebral Palsy

Interventions

DEVICE

Bootle Blast Intervention

Bootle Blast is a movement-tracking, mixed-reality therapeutic video game delivered in the home using the Orbbec Persee 3D camera-computer. An occupational therapist calibrates the system to each child's range and speed of motion and targeted therapy goals. Families are trained to set up and use the system. Participants then complete 12 weeks of home-based practice targeting 15-20 minutes per day, 3-4 days per week. The system automatically records active play time, movement counts, and performance data. Some participants are randomized to receive weekly monitoring coach phone calls for motivational and technical support.

OTHER

Standard Care (Comparator)

Participants continue with their usual care, which may include routine stretching, maintenance exercises, and consultative visits with their healthcare professionals. Targeted upper-limb therapies (e.g., constraint therapy, botulinum toxin, casting) are excluded during the study period.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Holland Bloorview Kids Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Elaine Biddiss, PhD · Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

  • Virginia Wright, PhD · Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-06
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07289360 on ClinicalTrials.gov