Testing a Mixed-Reality Video Game for Home-Based Practice of Arm-Hand Skills for Children With Cerebral Palsy: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
Locations
Other Locations
Canada
Grandview Kids
NOT_YET_RECRUITING
Ajax
Children's Hospital of Eastern Ontario
RECRUITING
Ottawa
Holland Bloorview Kids Rehabilitation Hospital
RECRUITING
Toronto
Contact Information
Primary
Selvi Research Coordinator, MEng
ssert@hollandbloorview.ca
416-425-6220
Backup
Gloria Research Manager, MSc
glee@hollandbloorview.ca
416-425-6220
Time Frame
Start Date: 2025-12-06
Estimated Completion Date: 2027-01
Participants
Target number of participants: 46
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Holland Bloorview Kids Rehabilitation Hospital

This content was sourced from clinicaltrials.gov