Bootle Blast: Pilot Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorHolland Bloorview Kids Rehabilitation Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bootle Blast Intervention
DeviceBootle 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)
Other interventionParticipants 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Bootle Blast Play Phase (0 - 12 weeks) followed by Standard Care (12 - 24 weeks)Experimental treatment 2 interventions
Group B: Waitlist Comparison - Standard Care (0-12 weeks) followed by Bootle Blast Play Phase (12-24 weeks)Other 2 interventions
Trial outcomes
Primary outcomes
1
Recruitment Rate
Number of participants enrolled per month across all study sites. Assessed against feasibility criterion of ≥4 participants/month.
Time frame
Throughout 24-week study period.2
Attrition Rate
Number and proportion of enrolled participants who do not complete the scheduled assessments at 12 or 24 weeks. Feasibility criterion: \<15% attrition.
Time frame
Throughout 24-week study period.3
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.
Time frame
Weeks 0-12 (Experimental Group), Weeks 12-24 (Waitlist Comparison Group).4
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.
Time frame
Week 12 (Experimental Group), Week 24 (Waitlist Comparison Group).Secondary outcomes
1
Quality of Upper Extremity Skills Test (QUEST)
Unimanual domain scores assessing dissociated movement, grasp, weight bearing, and protective extension.
Time frame
Baseline, 12 weeks, 24 weeks.2
Grip Strength (Modified Sphygmomanometer)
Grip strength of the hemiplegic hand as an indicator of selective motor control.
Time frame
Baseline, 12 weeks, 24 weeks.3
Active Range of Motion (aROM)
Active range of motion of wrist, elbow, and shoulder on the hemiplegic side measured using a manual goniometer.
Time frame
Baseline, 12 weeks, 24 weeks.4
Box and Block Test (BBT)
Manual dexterity measured as the number of blocks transferred in one minute for each hand.
Time frame
Baseline, 12 weeks, 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Holland Bloorview Kids Rehabilitation Hospital
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov