Video Game for Home-based Rehabilitation for Children With Hemiplegia

NCT04009031 | Terminated

• 1 other identifier: 12-365
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Hemiplegic Cerebral Palsy

Keywords

video games; upper extremity; rehabilitation; cerebral palsy

Outcome Measures

Primary Outcomes (4)

• Video game logs

  Addresses research question 1. Every time the computer is turned on to play the video game, a video game log is automatically generated. The game logs active play time (i.e. time in minutes spent actively engaging in therapeutic movements) and passive play time (e.g. time spent navigating menus). Additional data that is recorded in game logs includes: game scores, games played and time in each game, rewards collected, and location of the joints (e.g. elbow, shoulder) as tracked by the Microsoft Kinect sensor. Data recorded in the video game will be used to identify the percentage of children that met their weekly play time goal, and on how many weeks this goal was achieved.

  Through out the 12-week intervention.

• Change in the Canadian Occupational Performance Measure (COPM)

  Addresses research question 2. COPM evaluates self- or parent-reported satisfaction and performance on self-identified therapy goals. Participants will identify, with the help of the occupational therapists during the baseline assessment, 1-3 upper limb goals related to daily life activities (e.g., tie shoelaces). Parent and child will rate together performance and satisfaction with performance on a 10-point scale (1 is poor/low and 10 is good/high) for each goal.

  baseline (week 0), post-intervention (week 13), and follow-up (week 17)

• Change in the Assisting Hand Assessment (AHA)

  Addresses research question 2. The AHA evaluates the use of the affected hand in assisting during the performance of 22 bimanual activities. Each task is rated on a 4-point rating scale (4=effective, 0= does not do). Tasks include object manipulation from the AHA toy kit, which are scored under the categories of general use, arm use, grasp and release, fine motor adjustments and coordination and pace. Rasch analysis converts raw scores into a logit-based scale ranging from 0-100, with higher scores representing a higher ability.

  baseline (week 0), post-intervention (week 13), and follow-up (week 17)

• Semi-structured interviews

  Addresses research question 3. Parent and child will participate in a post intervention semi-structured interview to explore features related to engagement and intervention acceptability.

  Post-intervention (week 13).

Secondary Outcomes (4)

• Change in range of motion

  baseline (week 0), post-intervention (week 13) and follow-up (week 17)

• Grip strength

  baseline (week 0), post-intervention (week 13) and follow-up (week 17)

• Change in Box and Block test

  baseline (week 0), post-intervention (week 13) and follow-up (week 17)

• Change in Children's Hand-use Experience Questionnaire (CHEQ)

  baseline (week 0), post-intervention (week 13) and follow-up (week 17)

Study Arms (1)

Bootle Blast

EXPERIMENTAL

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.

Device: Bootle Blast

Interventions

Bootle Blast 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.

Bootle Blast

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Ontario Brain Institute: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 37502272 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elaine Biddiss, PhD

  Bloorview Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Participants will undergo a clinical assessment at 3-time points: baseline, post-intervention, and one-month follow-up. Clinical assessments will take approximately 2 hours and will be carried out at the Holland Bloorview Kids Rehabilitation Hospital by an occupational therapist. A research assistant will visit the child's home 3 times throughout the duration of the intervention (weeks 1, 6 and 12). During the last home visit, semi-structured interviews will be conducted individually with the parent and child.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 5, 2019
• Study Start: October 9, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)