Bootle Blast: Pilot Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Recruitment Rate — Throughout 24-week study period.
  Number of participants enrolled per month across all study sites. Assessed against feasibility criterion of ≥4 participants/month.
• Attrition Rate — Throughout 24-week study period.
  Number and proportion of enrolled participants who do not complete the scheduled assessments at 12 or 24 weeks. Feasibility criterion: \<15% attrition.
• Adherence to Bootle Blast Intervention — Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).
  Adherence measured using system-logged data, including minutes of active therapeutic play, passive play, and number of intentional therapeutic movements (e.g., reach, cross-body reach, grasp-and-release). Target dose: ≥10 hours of active play over 12 weeks.
• Intervention Acceptability Survey — Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group).
  Child and parent ratings of (i) satisfaction with the Bootle Blast intervention (e.g. therapeutic content, game content, challenge level, support provided), (ii) perceived impact and any unmet needs; and (iii) appropriateness and burden of study protocols (e.g. outcome measures, target dose). Comparison participants will be asked about the acceptability of not getting the Bootle Blast program right away.
• Monitoring Coach Logbook — Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).
  Documentation of weekly coach contacts (duration, content type, informational/motivational support) to assess feasibility and perceived value of coach involvement.
• Technical Assistance Requests — Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).
  Frequency and nature of technical support inquiries related to Bootle Blast equipment setup, functionality, and home use.
• Semi-Structured Interviews — Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group).
  Qualitative interviews exploring enablers and barriers to engagement, motivational factors, and experience with the intervention. Conducted separately with children and caregivers.
• Engagement (PRIME-C and PRIME-P) — Weeks 1, 6, and 12 of each participant's Bootle Blast intervention period.
  Parent- and child-reported engagement using the Pediatric Rehabilitation Intervention Measure of Engagement (affective, behavioral, cognitive components).
• In-Game Engagement Prompts — Weekly during Bootle Blast intervention.
  Child-reported ratings of enjoyment, challenge, and effort through weekly in-game prompts.

Trial sites (3)

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