Video Game for Home-based Rehabilitation for Children With Hemiplegia

Child Clinical Trial

Official title:

Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04009031
• Other study ID #: 12-365
• Status: Terminated
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2023
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Child
• Hemiplegic Cerebral Palsy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council, Canada, Ontario Brain Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Primary	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)
Primary	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	Change in range of motion	Active range of motion of the shoulder, elbow and wrist will be measured bilaterally via goniometer.	baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Secondary	Grip strength	Assesses isometric muscular strength of the hand and forearm. Measured bilaterally via a hand-held dynamometer.	baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Secondary	Change in Box and Block test	The test consists a wooden box with two compartments with a vertical division and 150 small cubes. Measures unilateral gross manual dexterity by asking the participant to pass the maximum number of cubes possible above the division, from one side to another, in 60 seconds.	baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Secondary	Change in Children's Hand-use Experience Questionnaire (CHEQ)	Captures the child perceived quality and effectiveness of using their affected hand in 29 bilateral tasks. It can be completed by the parent or the child.	baseline (week 0), post-intervention (week 13) and follow-up (week 17)