Recruiting

Observational StudyBootle Blast: Understanding the Family Experience

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT06161168

Conditions

Cerebral Palsy

Developmental Coordination Disorder

Developmental Disability

Autism Spectrum Disorder

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Bootle Blast Play Phase (B)

Study Details

Brief summary:

One in 60 children have a physical disability that can impact activities and participation. Occupational and physical therapies can be of great benefit, but are costly and difficult to access. Working with children, parents and clinicians, the investigators developed a mixed reality video game, Bootle Blast, which children can play to develop motor skills. Using a 3D sensor, Bootle Blast tracks movements and manipulation of real-life objects. Since 2017, Bootle Blast has been used in clinics by Holland Bloorview, Canada's largest children's rehabilitation hospital. 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 yet to be trialed in "real-world" contexts.

To understand real-world implementation, Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value. User experience will inform product, training and resource development. The research team combines expertise in engineering design, medicine, physiotherapy, qualitative methods, commercialization, knowledge translation, and includes young people with lived experience.

Conditions

Cerebral Palsy

Developmental Coordination Disorder

Developmental Disability

Autism Spectrum Disorder

Spinal Cord Injuries

Study ID

NCT06161168

Start date

Jul 7, 2022

Status verified date

Aug, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Child Participant Inclusion Criteria:

Any motor condition that can be addressed by the Bootle Blast system;
Interest in developing motor skills practiced in BootleBlast;
Aged 6-17 years;
Sufficient cognitive capacity to play BootleBlast as indicated by caregiver/self report;
Able to communicate in English;
Intermittent access to internet;
Ability to participate in video calling;
Have a device to record and upload short videos;
Have a caregiver willing to participate.

Child Participant Exclusion Criteria:

Uncontrolled epilepsy triggered by video games;
Medical condition making the physical activity in BootleBlast unsafe;
Visual and/or hearing limitations affecting BootleBlast play;
No access to internet at home
Has previously participated in a study related to Bootle Blast.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Baseline Phase (10 or 21 days)

In this study, participants will be randomly allocated to a baseline (A) phase that is further divided into two sub-phases, with different durations of either 10 or 21 days. The allocation to different durations of the baseline phase is randomized in order to mitigate threats to internal validity. During the baseline (A) phase, a representative baseline will be established through repeated measurements of the PQRS. Following the baseline phase (A), the 8-week intervention phase (B) is implemented, followed by a second 3-week (A) phase. There is no separate control group in this study, and all participants receive the same intervention during the intervention phase (B).

Interventions

Bootle Blast Play Phase (B)

Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value.

During the 8-week intervention phase (B), children will have Bootle Blast at home and play it according to their family-directed playtime goals. Weekly logs of therapy activities and problems encountered while playing will be collected through survey links. Additionally, families will record a video of their child performing the tasks associated with their COPM goals on a weekly basis. After the 8-week intervention (B) phase, participants will enter a second 3-week baseline (A) phase, during which they'll be asked to stop playing Bootle Blast, and the game will be programmatically locked to prevent further play.

Primary outcome measure

Canadian Occupational Performance Measure (COPM) [ Time Frame: First and last day of Baseline Phase; 8th week of Intervention Phase; 3rd week of Follow-up Phase ]
Performance Quality Rating Scale (PQRS) [ Time Frame: Weekly throughout study completion (14 weeks) ]

Central Contacts and Locations

Central contacts

Elaine Biddiss, PhD

416-425-6220 ebiddiss@hollandbloorview.ca

Ajmal Khan, MHSc

416-425-6220 akhan@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G 1R8

Contacts

Elaine Biddiss, PhD

416-425-6220 ebiddiss@hollandbloorview.ca

Ajmal Khan, MHSc

416-425-6220 akhan@hollandbloorview.ca

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Dec 7, 2023

Last verified

Aug, 2023

Keywords

Hand function
Arm function
At-home rehabilitation
Trunk stability
Balance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2023-12-07.