ChildNCT04009031
Video Game for Home-based Rehabilitation for Children With Hemiplegia
A study testing Bootle Blast in people with Child and Hemiplegic Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Child, Hemiplegic Cerebral Palsy
- What is being tested?
- Bootle Blast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 9 Oct 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
Official title: Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.
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.
Read the 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
- Being tested
- Bootle Blast
- Keywords
- video games, upper extremity, rehabilitation, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bootle BlastDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bootle Blast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (week 13).
Secondary outcomes (4)
Change in range of motion
Active range of motion of the shoulder, elbow and wrist will be measured bilaterally via goniometer.
Measured: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Grip strength
Assesses isometric muscular strength of the hand and forearm. Measured bilaterally via a hand-held dynamometer.
Measured: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
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.
Measured: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
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.
Measured: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start9 Oct 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: COVID-19 pandemic halted recruitment as of March 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 (weeks 1, 6 and 12). During the last home visit, semi-structured interviews will be conducted individually with the parent and child.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Canadian Institutes of Health Research (CIHR), Ontario Brain Institute
- Responsible party
- Principal investigator, Elaine Biddiss, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Elaine Biddiss, PhD, Principal investigator, Bloorview Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009031
- Sponsor's protocol ID
- 12-365
- Status last verified
- Apr 2023
- First submitted
- 14 Jun 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
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.
PubMed 37502272
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Video Game for Home-based Rehabilitation for Children With Hemiplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04009031
- Acronym / sponsor ID
- 12-365
- Conditions
- Child, Hemiplegic Cerebral Palsy
- Keywords
- video games, upper extremity, rehabilitation, cerebral palsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic halted recruitment as of March 2020.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Canadian Institutes of Health Research (CIHR), Ontario Brain Institute
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 (weeks 1, 6 and 12). During the last home visit, semi-structured interviews will be conducted individually with the parent and child.
| Arm | Type | Receives |
|---|---|---|
| Bootle Blast | Experimental | Device: Bootle BlastBootle 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bootle BlastDuring 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. | Device | Bootle Blast |
Primary outcome
Video game logs
Time frame: Through out the 12-week intervention.
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.
Change in the Canadian Occupational Performance Measure (COPM)
Time frame: baseline (week 0), post-intervention (week 13), and follow-up (week 17)
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.
Change in the Assisting Hand Assessment (AHA)
Time frame: baseline (week 0), post-intervention (week 13), and follow-up (week 17)
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.
Semi-structured interviews
Time frame: Post-intervention (week 13).
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.
4 secondary outcomes
Change in range of motion
Time frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Grip strength
Time frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Change in Box and Block test
Time frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Change in Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: baseline (week 0), post-intervention (week 13) and follow-up (week 17)
Results and safety
The study was stopped early (reason given: COVID-19 pandemic halted recruitment as of March 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 37502272Chan-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.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Biddiss, PhD principal investigator
Bloorview Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bootle Blast in people with Child and Hemiplegic Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic halted recruitment as of March 2020.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video game logs (time frame: Through out the 12-week intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.