Recruiting

Bootle Blast

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT07289360

Conditions

Cerebral Palsy (CP)

Hemiplegic Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Bootle Blast Intervention

Standard Care (Comparator)

Study Details

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.

Conditions

Cerebral Palsy (CP)

Hemiplegic Cerebral Palsy

Study ID

NCT07289360

Start date

Dec 6, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bootle Blast Play Phase (0 - 12 weeks) followed by Standard Care (12 - 24 weeks)

Participants receive the Bootle Blast home-based intervention immediately after baseline in-person clinic assessment at 0 weeks. Families complete 12 weeks of home-based play targeting a prescribed practice dose (15-20 minutes/day, 3-4 days/week), alongside ongoing standard care activities. Participants may also be randomized to receive weekly monitoring coach calls providing motivational and technical support. Participants complete in-person clinical assessments again at 12 and 24 weeks, and provide repeated COPM-goal videos, PRIME engagement data, and system-logged play data during the intervention period. After the 12-week assessment, they transition to standard care without Bootle Blast for weeks 12-24.

other: Waitlist Comparison - Standard Care (0-12 weeks) followed by Bootle Blast Play Phase (12-24 weeks)

Participants continue with their usual standard care for the first 12 weeks after baseline assessment. During this period, they do not receive Bootle Blast but complete the same assessment schedule and repeated measures as the experimental group. After the 12-week assessment, they receive the Bootle Blast intervention following the same calibration and training procedure, with randomized monitoring coach support. They then complete the 12-week Bootle Blast period from weeks 12 to 24, along with follow-up assessments and repeated measurements. This group is likely representative of how Bootle Blast would be used in practice (complement or supplement to standard care).

Interventions

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: Throughout 24-week study period. ]
  • Attrition Rate [ Time Frame: Throughout 24-week study period. ]
  • Adherence to Bootle Blast Intervention [ Time Frame: Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group). ]
  • Intervention Acceptability Survey [ Time Frame: Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group). ]
  • Monitoring Coach Logbook [ Time Frame: Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group). ]
  • Technical Assistance Requests [ Time Frame: Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group). ]
  • Semi-Structured Interviews [ Time Frame: Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group). ]
  • Engagement (PRIME-C and PRIME-P) [ Time Frame: Weeks 1, 6, and 12 of each participant's Bootle Blast intervention period. ]
  • In-Game Engagement Prompts [ Time Frame: Weekly during Bootle Blast intervention. ]

Central Contacts and Locations

Central contacts

Selvi Research Coordinator, MEng

416-425-6220ssert@hollandbloorview.ca

Gloria Research Manager, MSc

416-425-6220glee@hollandbloorview.ca

Locations

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Adina Research Assistant, MSc

613-737-7600ANizam@cheo.on.ca

Michelle Research Coordinator, PhD

613-737-7600MLarin@cheo.on.ca

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G 1R8

Contacts

Selvi Research Coordinator, MEng

416-425-6220ssert@hollandbloorview.ca

Gloria Research Manager, MSc

416-425-6220glee@hollandbloorview.ca

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Home-Based Rehabilitation
  • Interactive Video Game Therapy
  • Digital Therapeutics
  • Tele-Rehabilitation
  • Gamified Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2026-01-08.