Video Game for Home-based Rehabilitation for Children With Hemiplegia

NCT ID: NCT04009031

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2020-03-15

Brief Summary

This study evaluates the feasibility of a low-cost, movement tracking video game (Bootle Blast) to 1) sustain engagement in children with cerebral palsy (CP) during a 12-week intervention; and 2) generate changes in upper limb functional motor outcomes following the intervention.

Detailed Description

Children with Cerebral Palsy (CP) can benefit from home-based practice of therapy exercises. However, sustaining engagement in home-based therapy is challenging. Bootle Blast is a low-cost video game that uses the Microsoft Kinect sensor to track upper limb movements and interactions with real-life objects (e.g. musical instruments, building blocks). To play Bootle Blast, the child needs to use the hemiplegic arm/hand to play unilateral game activities, and highly involve it in bilateral activities.

This study will answer our research questions: 1) to what extent can children achieve a weekly play-time goal (PTG) over a 12-week intervention (adherence) when the PTG is family identified? 2) to what extent can the use of Bootle Blast lead to improvements in UL motor function? and 3) what are the participant's experiences of using BB for home rehabilitation?

As measures of feasibility we hypothesize that 1a) 75% of children will achieve their weekly play time goal and complete the 12-week intervention and 2) 75% children who achieve their weekly play time goal will improve in one or more UL motor outcome measures.

Conditions

Child; Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bootle Blast

Bootle Blast is a series of 13 mini-games targeting different upper limb motor therapy goals. Bootle Blast is designed with many of the features of mainstream video games known to be appealing to young people. Game rewards are linked to meeting therapeutic objectives, such as daily play targets that are customizable to each child. Bootle Blast is played through movements of the upper limbs tracked via a low-cost camera/sensor (Microsoft Kinect, no hand-held controls needed). The movements required to play are customizable to each child's range of motion. Some of the mini-games are "mixed reality", where children interact and manipulate real-life objects (e.g. musical instruments, coloured building blocks) to play the game. The use of skeletal tracking and mixed reality enables both gross and fine motor skills to be practiced in line with each child's therapy goals and motor abilities.

Group Type: EXPERIMENTAL

Bootle Blast

Intervention Type: DEVICE

During the baseline assessment, an occupational therapist will calibrate the video game to the child's therapy needs and functional abilities. Within a week of the first assessment, the research team will set up the video game in the participant's home where it will remain for 12 weeks. Training on how to play the game and a user manual will be provided. The researcher will work with each family to establish a play objective (minutes/day and days/week) that considers the family's schedule. Five-minute telephone check-in calls will be done weekly.

Interventions

Bootle Blast

During the baseline assessment, an occupational therapist will calibrate the video game to the child's therapy needs and functional abilities. Within a week of the first assessment, the research team will set up the video game in the participant's home where it will remain for 12 weeks. Training on how to play the game and a user manual will be provided. The researcher will work with each family to establish a play objective (minutes/day and days/week) that considers the family's schedule. Five-minute telephone check-in calls will be done weekly.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• diagnosis of hemiplegic Cerebral Palsy, Gross Motor Function Classification System and Manual Abilities Classification System Levels I to III, able to co-operate, understand and follow simple instructions for gameplay, live within 30 km of the Holland Bloorview Kids Rehabilitation Hospital, having a caregiver willing to participate.

Exclusion Criteria

• currently receiving active occupational or physical therapy that may impact motor function of the upper limb, Botulinum Toxin treatment within 3 months or Constraint-Induced Movement Therapy within 6 months of study enrollment, visual, cognitive or auditory limitations at a level that would interfere with gameplay, uncontrolled epilepsy or history of epilepsy related to video game play.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ontario Brain Institute

OTHER

Sponsor Role: collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elaine Biddiss

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Biddiss, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloorview Research Institute

Locations

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Chan-Viquez D, Khan A, Munce S, Fehlings D, Wright FV, Biddiss E. Understanding a videogame home intervention for children with hemiplegia: a mixed methods multi-case study. Front Med Technol. 2023 Jul 12;5:1217797. doi: 10.3389/fmedt.2023.1217797. eCollection 2023.

Reference Type: DERIVED

PMID: 37502272 (View on PubMed)

Other Identifiers

12-365

Identifier Type: -

Identifier Source: org_study_id