Bootle Blast: Pilot Randomized Controlled Trial

NCT07289360 | Recruiting

• 1 other identifier: 1954
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Recruitment Rate

  Number of participants enrolled per month across all study sites. Assessed against feasibility criterion of ≥4 participants/month.

  Throughout 24-week study period.

• Attrition Rate

  Number and proportion of enrolled participants who do not complete the scheduled assessments at 12 or 24 weeks. Feasibility criterion: \<15% attrition.

  Throughout 24-week study period.

• Adherence to Bootle Blast Intervention

  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.

  Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).

• Intervention Acceptability Survey

  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.

  Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group).

• Monitoring Coach Logbook

  Documentation of weekly coach contacts (duration, content type, informational/motivational support) to assess feasibility and perceived value of coach involvement.

  Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).

• Technical Assistance Requests

  Frequency and nature of technical support inquiries related to Bootle Blast equipment setup, functionality, and home use.

  Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).

• Semi-Structured Interviews

  Qualitative interviews exploring enablers and barriers to engagement, motivational factors, and experience with the intervention. Conducted separately with children and caregivers.

  Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group).

• Engagement (PRIME-C and PRIME-P)

  Parent- and child-reported engagement using the Pediatric Rehabilitation Intervention Measure of Engagement (affective, behavioral, cognitive components).

  Weeks 1, 6, and 12 of each participant's Bootle Blast intervention period.

• In-Game Engagement Prompts

  Child-reported ratings of enjoyment, challenge, and effort through weekly in-game prompts.

  Weekly during Bootle Blast intervention.

Secondary Outcomes (12)

• Quality of Upper Extremity Skills Test (QUEST)

  Baseline, 12 weeks, 24 weeks.

• Grip Strength (Modified Sphygmomanometer)

  Baseline, 12 weeks, 24 weeks.

• Active Range of Motion (aROM)

  Baseline, 12 weeks, 24 weeks.

• Box and Block Test (BBT)

  Baseline, 12 weeks, 24 weeks.

• Assisting Hand Assessment (AHA)

  Baseline, 12 weeks, 24 weeks.

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Bootle Blast Intervention; Other: Standard Care (Comparator)

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

OTHER

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).

Device: Bootle Blast Intervention; Other: Standard Care (Comparator)

Interventions

Bootle Blast Intervention DEVICE

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.

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

Standard Care (Comparator) OTHER

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.

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

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

Grandview Kids

Ajax, Ontario, L1T 0R3, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elaine Biddiss, PhD

  Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

  PRINCIPAL INVESTIGATOR

• Virginia Wright, PhD

  Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selvi Research Coordinator, MEng

CONTACT

416-425-6220; ssert@hollandbloorview.ca

Gloria Research Manager, MSc

CONTACT

416-425-6220; glee@hollandbloorview.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Occupational therapists administering the clinical assessments at 0, 12, and 24 weeks are blinded to group allocation. All assessments are video recorded and subsequently scored, with some scored by separate blinded raters who are also unaware of group assignment and time point.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a 24-week mixed-methods pilot randomized controlled trial using a parallel-group design. Participants are allocated by minimization to either the Experimental Group, which receives the Bootle Blast intervention immediately, or the Waitlist Comparison Group, which continues standard care for the first 12 weeks. Both groups complete in-person assessments at 0, 12, and 24 weeks. After the 12-week assessment, the Waitlist Group receives the same Bootle Blast intervention. Within each arm, participants are further randomized to receive or not receive weekly monitoring coach calls to explore added support effects. Repeated measurements (system logs, clinical assessments, COPM-goal videos, and engagement metrics) are collected throughout to evaluate the feasibility and acceptability of conducting a larger-scale RCT.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)