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出境医 / 临床实验 / Video Game for Home-based Rehabilitation for Children With Hemiplegia

Video Game for Home-based Rehabilitation for Children With Hemiplegia

Study Description
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.

Condition or disease Intervention/treatment Phase
Child Hemiplegic Cerebral Palsy Device: Bootle Blast Not Applicable

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: 1a) to what extent can Bootle Blast sustain engagement in children with CP over a 12-week home intervention? 1b) from the perspective of children with CP and their parents, what are the intervention features influencing engagement? and 2) to what extent can the use of Bootle Blast lead to improvements in UL motor function when the playtime goal is family-identified? 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 (week 1, 6 and 12). During the first and last home visits, semi-structured interviews will be conducted individually with the parent and child.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Video game logs [ Time Frame: Through out the 12-week intervention. ]
    Addresses research question 1a. 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.

  2. Semi-structured interviews [ Time Frame: baseline (week 0) and post-intervention (week 13). ]
    Addresses research question 1b. Parent and child will participate in semi-structured interviews to explore influencing intervention features related to engagement and intervention acceptability.

  3. Change in Melbourne Assessment of Unilateral Upper Limb Function 2 (MA-II) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Addresses research question 2. MA-II evaluates the quality of unilateral upper limb movements in children and youth with upper extremity hemiplegia. Fourteen arm and hand movement items are scored based on the elements of range of motion, accuracy, fluency and dexterity.


Secondary Outcome Measures :
  1. Logbook [ Time Frame: throughout the 12-week intervention. ]
    The hard-copy logbook provided to the participants contains 3 questions related to motivation, enjoyment and physical exertion answered through a numerical scale from 1 to 10. This is completed after each play session.

  2. Change in Self-reported Experience of Activity Settings (SEAS) [ Time Frame: weeks 6 and 12 of intervention ]
    The SEAS is a survey that asks about the experiences of the child related to a recreational or leisure activity. It provides information about the participant's thoughts, mood and feelings while doing an activity. Each question is scored on a 5-point nominal scale ranging from "agree" to "disagree".

  3. Change in range of motion [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Active range of motion of the shoulder, elbow and wrist will be measured bilaterally via goniometer.

  4. Grip strength [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Assesses isometric muscular strength of the hand and forearm. Measured bilaterally via a hand-held dynamometer.

  5. Change in Assisting Hand Assessment (AHA) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Evaluates how children and youth with hemiplegia use their affected hand in bilateral activities. The assessments consist on 22 items in which bimanual performance is observed and scored on a 4-point numerical scale.

  6. Change in Box and Block test [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    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.

  7. Change in Children's Hand-use Experience Questionnaire (CHEQ) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    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.

  8. Change in the Canadian Occupational Performance Measure (COPM) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Evaluates the performance, and the satisfaction with performance, of self-identified therapy goals. The participants rate their own level over a 10-point numerical scale (1 is poor/low and 10 is high/good) for each of their identified goals. Goals will be focused on the upper limb.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Daniela Chan Viquez, MSc 416-425-6220 ext 3544 dchanviquez@hollandbloorview.ca
Contact: Ajmal Khan, MSc 416-425-6220 ext 3544 akhan@hollandbloorview.ca

Locations
Layout table for location information
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Elaine Biddiss, PhD    416-425-6220 ext 3544    ebiddiss@hollandbloorview.ca   
Contact: Ajmal Khan, MSc    416-425-6220 ext 3544    akhan@hollandbloorview.ca   
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Natural Sciences and Engineering Research Council, Canada
Canadian Institutes of Health Research (CIHR)
Ontario Brain Institute
Investigators
Layout table for investigator information
Principal Investigator: Elaine Biddiss, PhD Bloorview Research Institute
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date March 6, 2020
Actual Study Start Date  ICMJE October 9, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Video game logs [ Time Frame: Through out the 12-week intervention. ]
    Addresses research question 1a. 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.
  • Semi-structured interviews [ Time Frame: baseline (week 0) and post-intervention (week 13). ]
    Addresses research question 1b. Parent and child will participate in semi-structured interviews to explore influencing intervention features related to engagement and intervention acceptability.
  • Change in Melbourne Assessment of Unilateral Upper Limb Function 2 (MA-II) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Addresses research question 2. MA-II evaluates the quality of unilateral upper limb movements in children and youth with upper extremity hemiplegia. Fourteen arm and hand movement items are scored based on the elements of range of motion, accuracy, fluency and dexterity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Logbook [ Time Frame: throughout the 12-week intervention. ]
    The hard-copy logbook provided to the participants contains 3 questions related to motivation, enjoyment and physical exertion answered through a numerical scale from 1 to 10. This is completed after each play session.
  • Change in Self-reported Experience of Activity Settings (SEAS) [ Time Frame: weeks 6 and 12 of intervention ]
    The SEAS is a survey that asks about the experiences of the child related to a recreational or leisure activity. It provides information about the participant's thoughts, mood and feelings while doing an activity. Each question is scored on a 5-point nominal scale ranging from "agree" to "disagree".
  • Change in range of motion [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Active range of motion of the shoulder, elbow and wrist will be measured bilaterally via goniometer.
  • Grip strength [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Assesses isometric muscular strength of the hand and forearm. Measured bilaterally via a hand-held dynamometer.
  • Change in Assisting Hand Assessment (AHA) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Evaluates how children and youth with hemiplegia use their affected hand in bilateral activities. The assessments consist on 22 items in which bimanual performance is observed and scored on a 4-point numerical scale.
  • Change in Box and Block test [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    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.
  • Change in Children's Hand-use Experience Questionnaire (CHEQ) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    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.
  • Change in the Canadian Occupational Performance Measure (COPM) [ Time Frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17) ]
    Evaluates the performance, and the satisfaction with performance, of self-identified therapy goals. The participants rate their own level over a 10-point numerical scale (1 is poor/low and 10 is high/good) for each of their identified goals. Goals will be focused on the upper limb.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video Game for Home-based Rehabilitation for Children With Hemiplegia
Official Title  ICMJE Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.
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: 1a) to what extent can Bootle Blast sustain engagement in children with CP over a 12-week home intervention? 1b) from the perspective of children with CP and their parents, what are the intervention features influencing engagement? and 2) to what extent can the use of Bootle Blast lead to improvements in UL motor function when the playtime goal is family-identified? 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
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 (week 1, 6 and 12). During the first and last home visits, semi-structured interviews will be conducted individually with the parent and child.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Child
  • Hemiplegic Cerebral Palsy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 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.
Intervention: Device: Bootle Blast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009031
Other Study ID Numbers  ICMJE 12-365
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD
Responsible Party Holland Bloorview Kids Rehabilitation Hospital
Study Sponsor  ICMJE Holland Bloorview Kids Rehabilitation Hospital
Collaborators  ICMJE
  • Natural Sciences and Engineering Research Council, Canada
  • Canadian Institutes of Health Research (CIHR)
  • Ontario Brain Institute
Investigators  ICMJE
Principal Investigator: Elaine Biddiss, PhD Bloorview Research Institute
PRS Account Holland Bloorview Kids Rehabilitation Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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