Bootle Blast for Cerebral Palsy

Recruiting at 2 trial locations

Overseen By Selvi Research Coordinator, MEng

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: Recent surgery, Botulin toxin, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a video game called Bootle Blast to determine if it can improve hand and arm function in children with hemiplegic cerebral palsy, a condition affecting movement. The game provides engaging therapy at home, making treatment more accessible for families. Researchers aim to assess whether using Bootle Blast at home for 12 weeks is practical and if it enhances motor skills more than standard care alone. Children aged 6-17 with one-sided cerebral palsy who have a TV and space to play at home may be suitable for this study. Participants will either begin using the game immediately or after a 12-week wait, allowing researchers to compare results. As an unphased trial, this study offers a unique opportunity to explore innovative therapy options for children.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving active treatments that impact upper limb function, you may not be eligible to participate.

What prior data suggests that the Bootle Blast intervention is safe for children with cerebral palsy?

Research has shown that the Bootle Blast program helps children with cerebral palsy. In earlier studies, children aged 6-17 who struggled with handling objects improved by using Bootle Blast at home. This video game therapy is fun and easy to use, focusing on enhancing hand and arm movements.

These studies have not linked any serious side effects to Bootle Blast. Families found it a valuable addition to their regular care. The game makes practicing movements enjoyable and interactive, and it appears safe for home use.

Overall, Bootle Blast offers a safe option for children with cerebral palsy, providing a new way to support physical therapy at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bootle Blast intervention for cerebral palsy because it offers a playful, home-based approach that integrates seamlessly with standard care. Unlike traditional therapies that often require clinical settings and can be more time-intensive, Bootle Blast empowers families to engage in targeted exercises at home, requiring just 15-20 minutes a day. This method not only makes therapy more accessible but also encourages consistent practice, potentially leading to better outcomes. Additionally, the inclusion of motivational coach support for some participants is a novel feature that could enhance engagement and adherence to the therapy plan.

What evidence suggests that Bootle Blast is effective for improving upper-limb function in children with cerebral palsy?

Research has shown that Bootle Blast, a video game that tracks movement, has helped children with cerebral palsy. In earlier studies, playing Bootle Blast at home improved children's arm use. Another study found that an 8-week home program with Bootle Blast enhanced movement. Families reported that Bootle Blast was beneficial for their children. In this trial, participants will either start with the Bootle Blast intervention or begin with standard care before transitioning to Bootle Blast. These findings suggest that Bootle Blast could be a useful tool for improving motor skills in children with cerebral palsy. ^{1 2 4 5 6}

Who Is on the Research Team?

Virginia Wright, PhD

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

Elaine Biddiss, PhD

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute

Are You a Good Fit for This Trial?

This trial is for children and youth aged 6-17 with hemiplegic cerebral palsy. They should be able to complete in-person assessments and use the Bootle Blast game at home regularly. Those who can't commit to the study duration or have conditions that interfere with gameplay are excluded.

Inclusion Criteria

MACS levels I to III

I have been diagnosed with hemiplegic cerebral palsy.

Ability to communicate in English

Exclusion Criteria

I've had arm surgery, botox injections, or casting in the last 4 months.

Medical condition impeding safe participation in physical activity associated with Bootle Blast

I am undergoing or will undergo treatments that could affect my arm function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bootle Blast Play Phase

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.

12 weeks

3 in-person assessments (baseline, 12 weeks, 24 weeks)

Standard Care

Participants transition to standard care without Bootle Blast for weeks 12-24.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bootle Blast Intervention

Trial Overview

The trial tests if a mixed-reality video game called Bootle Blast improves upper-limb function in kids with CP compared to usual care. Participants will either start playing immediately or after a waitlist period, using it several times a week at home.

How Is the Trial Designed?

Group I: Waitlist Comparison - Standard Care (0-12 weeks) followed by Bootle Blast Play Phase (12-24 weeks) Experimental Treatment 2 Interventions

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).

Group II: Bootle Blast Play Phase (0 - 12 weeks) followed by Standard Care (12 - 24 weeks) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07289360

Bootle Blast: Pilot Randomized Controlled Trial

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11373410/

Feasibility of a home-based home videogaming ...

This study assessed the implementation and effectiveness of an 8-week, upper limb (UL) home-based intervention with a movement-tracking videogame (Bootle Blast)

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06161168

Bootle Blast: Understanding the Family Experience

Home use of Bootle Blast has resulted in positive clinical outcomes for children with cerebral palsy. Bootle Blast is not yet commercially ...

4.

trialx.com

trialx.com/clinical-trials/listings/259044/bootle-blast-understanding-the-family-experience/

Bootle Blast: Understanding the Family Experience

Home use of Bootle Blast has resulted in positive clinical outcomes for children with cerebral palsy. Bootle Blast is not yet commercially available and has ...

5.

ctv.veeva.com

ctv.veeva.com/study/bootle-blast-pilot-randomized-controlled-trial

Bootle Blast: Pilot Randomized Controlled Trial

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 ...

6.

hollandbloorview.ca

hollandbloorview.ca/research-education/bloorview-research-institute/research-centres-labs/pearl-lab-current-research/bootle-blast-pilot-rct

Bootle Blast: A Pilot Randomized Control Trial

A 24-week pilot RCT with 46 children with CP, aged 6-17 years who have difficulty handling objects. The intervention group will play Bootle Blast at home for 12 ...