Bootle Blast Intervention for Cerebral Palsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Universidad de Costa Rica, San Pedro, Costa Rica
Cerebral Palsy+1 More
Bootle Blast Home Intervention - Other
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Economic and geographic barriers can limit access to rehabilitation therapies for children with cerebral palsy (CP). These barriers are magnified in developing countries like Costa Rica, where 43% of children with disabilities do not have access to basic health services. To address this accessibility gap, effective and engaging approaches are needed to motivate and support children in practicing motor therapies at home. Bootle Blast (BB) is a low-cost, movement-tracking video game that encourages upper limb (UL) exercises at home. BB is mixed-reality; using real-life objects (e.g., toys) in gameplay to target fine motor skills. It is customizable to diverse abilities and therapy goals. BB applies best practices in video game design, theories of motivation and motor learning, to optimize engagement and clinical effectiveness. This mixed-methods study will assess the feasibility of a family-centred BB home intervention among children with hemiplegic CP. We will address four areas of feasibility to 1) Understand the demand for the BB intervention (i.e., expressed interest in the program), 2) Establish probable efficacy for clinical outcomes related to UL function, activity, and participation, 3) Evaluate implementation of the 8-week BB intervention and 4) Explore acceptability (e.g., participants' experiences). Fifteen children with a diagnosis of hemiplegic CP (7-17 yrs) and one of their primary caregivers will participate. This study consists of three phases, each one contributing to the development of the next one. In Phase 1 (demand), recruitment rates and percentage of children with appropriate in-home technology to play will be collected during screening. A pre-intervention interview will explore participants' expectations for the intervention. In Phase 2, study assessments will be performed via videoconference (probable efficacy). Measures will target UL activity and related participation. Children will play BB at home for 8 weeks. Computer-system logs and data from reported technical barriers will be collected (implementation). In Phase 3 parents and children will participate in a post-intervention interview to explore their experiences and perceived value of the BB program (acceptability). Worldwide, children face accessibility barriers to motor therapy services. This study will provide learnings on how therapy gaming interventions can/should be implemented to bridge accessibility gaps, engage children and improve access to care.

Eligible Conditions

  • Cerebral Palsy
  • Hemiplegic Cerebral Palsy

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)

Week 1
Count of number of intentional therapeutic movements achieved during active and passive playtime.
Week 15
Change on the children's hand-use experience questionnaire (CHEQ)
Week 15
Change in Canadian Occupational Performance Measure (COPM)
Week 15
Change on the Performance Quality Rating Scale (PQRS)
Week 15
Active Range of Motion (aROM)
Change in Quality of Upper Extremity Skills Test (QUEST)
Change in the Box and Blocks Test (BBT)
Change on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)

Trial Safety

Trial Design

1 Treatment Group

Bootle Blast Intervention
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Bootle Blast Intervention · No Placebo Group · N/A

Bootle Blast Intervention
Other
Experimental Group · 1 Intervention: Bootle Blast Home Intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4 & 5 (pre assessment sessions), week 15 (post assessment session)
Closest Location: Holland Bloorview Kids Rehabilitation Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2016First Recorded Clinical Trial
16 TrialsResearching Cerebral Palsy
43 CompletedClinical Trials

Who is running the clinical trial?

Universidad de Costa RicaOTHER
10 Previous Clinical Trials
14,203 Total Patients Enrolled
Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
54 Previous Clinical Trials
12,584 Total Patients Enrolled
22 Trials studying Cerebral Palsy
3,990 Patients Enrolled for Cerebral Palsy
Elaine Biddiss, PhDPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
3 Previous Clinical Trials
43 Total Patients Enrolled
3 Trials studying Cerebral Palsy
43 Patients Enrolled for Cerebral Palsy

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Children aged 18 years or older with motor impairment of the upper limb, as reported by the parent and assessed via telephone by the clinician-researcher (DC - Appendix B, telephone screening).
This age range was selected given the popularity of video games for children at this stage
Child and/or parent must have knowledge on how to use email and receive a video call or have a support person willing to assist them during the clinical assessment processes.
You have access to a cellphone or computer at home.
You are able to understand and follow simple instructions for game play.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References