Back to resultsHome Exercise Program Using Bootle Boot Camp
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bootle Boot Camp Home Exercise App - with Virtual Coach Botley
Bootle Boot Camp Home Exercise App - without Virtual Coach Botley
Sponsored by
About this trial
This is an interventional health services research trial for Cerebral Palsy
Eligibility Criteria
Physiotherapist Inclusion Criteria: Registered and in good standing with the College of Physiotherapists of Ontario Minimum 1-year pediatric clinical experience Caseload consists of clients with cerebral palsy (ages 6-12 years; GMFCS Level I-II) Works in public sector (Holland Bloorview) or private sector (clinics) within Ontario Has technology (e.g., laptop) and internet services needed to use Bootle Boot Camp, complete online surveys and video calls Has managerial and institutional approval Physiotherapist Exclusion Criteria: * Visual/auditory deficits that would limit the physiotherapist's ability to interact with the App Child Inclusion Criteria: Diagnosis of cerebral palsy (GMFCS Levels I-II) Ages 6-12 years Minimum 1 lower limb goal Able to complete 4 weekly exercise sessions using Bootle Boot Camp for 6 weeks Not currently receiving physiotherapy services more than once every two months (on an off block from physiotherapy) Normal or corrected to normal vision and hearing Child and parent can speak and understand English Has technology (e.g., laptop) and internet services needed to use Bootle Boot Camp, complete online surveys, and video calls Child's physiotherapist and parent able and willing to also participate in the study Child Exclusion Criteria: Botox injection in the last 6 weeks or orthopedic surgery in the last 6 months Has serial casting, Botox injection, orthopedic surgery or other significant medical intervention during the 6-week training period with the App Photosensitivity or unstable epilepsy triggered by video games, screen activities or TV light Visual or auditory deficits that would limit gameplay Respiratory, cardiovascular, or other significant medical condition that would limit safe gameplay Engaging in a progressive lower limb muscle strengthening or balance home exercise program as prescribed by a health care provider An extensive medical or therapeutic schedule (services scheduled on more than 3 days/week) Scheduled event (e.g., family or school trip) that would limit ability to perform 4 sessions/week for 6 weeks during training period with the App
Sites / Locations
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bootle Boot Camp with movement tracking feedback (virtual Coach Botley present)
Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent)
Arm Description
Bootle Boot Camp exercise sessions offered with movement tracking feedback through the presence of virtual coach Botley.
Bootle Boot Camp exercise sessions offered without movement tracking feedback through the absence of virtual coach Botley.
Outcomes
Primary Outcome Measures
Adherence (as a measure of behavioural engagement)
The number of exercise repetitions that are attempted each session will be tracked and recorded by the 3D camera computer system and will be expressed as a proportion of the total number of prescribed repetitions
Secondary Outcome Measures
Smileyometer Scale
Children will rate their level of fun and how helpful they feel the game is for their body after each exercise session using customized Smileyometer rating scales. The Smileyometer scale is a 5-point smiley face rating scale with anchors of 1 relating to "Awful" and 5 to "Brilliant" that is used to measure product liking. Higher scores reflect greater experienced fun.
Exercise fidelity
The total acceptable repetition count (based on predefined movement quality criteria) for each exercise will be tracked and recorded by the 3D camera computer system and will be expressed as a proportion of the total number of prescribed repetitions.
Bootle Boot Camp Acceptability Survey
Children will rate perceived therapeutic effectiveness of each version of the App after the 4-week comparison period using the study-specific Bootle Boot Camp Acceptability Survey. The survey consists of questions with open-ended responses, rating agreement with statements (e.g., I had fun playing Bootle Boot Camp) on a 5-point rating scale with 1 representing 'disagree' to 5 representing 'agree,' and selecting which version of the App they feel best answers each question (e.g., which version of the game was most helpful for your body?)
Five Time Sit to Stand Test
The test measures the time needed to complete five consecutive sit to stand cycles as fast as possible as a measure of lower limb functional strength. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Modified Timed Up and Go
The test measures the time in seconds to rise from a chair, walk 3m and return to sitting as a measure of functional mobility. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp.
One Leg Stance Test
The test measures the time in seconds that a child can balance on one leg as a measure of standing stability. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Pediatric Reach Test
The test measures the distance that a child can reach forward and sideways in standing and sitting as a measure of balance. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
30 Second Sit to Stand Test
The test measures the number of sit to stand cycles that a child can complete in 30 seconds as a measure of functional lower limb strength. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Mobile App Rating Scale
Parents will complete the Mobile App Rating Scale (MARS) for each version of the game to assess each version's value and usability. The MARS assesses App quality through 5 subscales: engagement, functionality, aesthetics, information quality and subjective quality, with questions asked using 1-5 rating scales. An App quality mean score and App subjective quality score is reported. Higher scores denote more positive feelings towards the App.
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure (COPM) will be used to assess client's performance and satisfaction on self-identified goals pre and post six weeks of Bootle Boot Camp game play. Children rate performance and satisfaction on each activity using 10-point rating scales (minimum score 1 and maximum score 10) with higher scores reflecting higher performance and satisfaction. A change of at least 2 points has been considered clinically meaningful.
System Usability Scale and Bootle Boot Camp Usability Survey
Physiotherapists will rate the usability of Bootle Boot Camp using the System Usability Scale (SUS) after they have used the App to prescribe a home exercise program to their client. The SUS is composed of 10 questions with SUS scores ranging from 0 to 100, with higher scores reflecting greater usability.
Pick-A-Mood
Before each exercise session, children will be asked how they are feeling using Pick-A-Mood, a cartoon-based self-report scale with eight characters representing eight different mood states.
Semi structured interviews
Children and parents will be interviewed post 6-weeks of Bootle Boot Camp game play to understand families' experiences with using the App for home exercise program completion
Wong-Bakers Faces Pain Scale
Before each exercise session, children will be asked to rate their level of pain using the Wong Bakers Faces Pain scale, ranging from no pain (score of 0) to the most pain possible (score of 5). Higher scores denote more pain.
Study-specific Energy Level Question
Before each exercise session, children will be asked to rate their level of energy using a study-specific energy level scale ranging from no energy (score of 0) to lots of energy (score of 10). Higher scores denote more energy.
Full Information
NCT ID
NCT05998239
First Posted
July 25, 2023
Last Updated
August 16, 2023
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT05998239
Brief Title
Home Exercise Program Using Bootle Boot Camp
Official Title
Testing Bootle Boot Camp - A New Movement Tracking App to Engage Kids in Home Exercise Programs
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to learn about the engagement and lower limb motor outcomes of children with cerebral palsy, ages 6-12 years, GMFCS Levels I-II, engaging in home-based movement practice using a novel therapy exercise Application, Bootle Boot Camp, offered with and without movement-tracking feedback.
Detailed Description
Adherence to home exercise programs is low. Interactive computer play (ICP) - any kind of computer game or virtual reality technology that allows users to interact with simulated objects in a virtual environment - offers a fun and motivational way to increase movement practice.
Bootle Boot Camp is a novel ICP technology developed by the Possibility Engineering and Research Lab at Holland Bloorview Kids Rehabilitation Hospital that uses a 3D motion tracking camera to provide real time feedback on skeletal movements during game play. It allows physiotherapists to prescribe personalized lower limb home exercise programs to clients.
The investigator's specific objectives are:
To compare participants' level of affective, behavioural, and cognitive engagement with Bootle Boot Camp with and without movement tracking feedback
To determine the quality of exercise performance when participants use Bootle Boot Camp with and without movement tracking feedback
To estimate the treatment response associated with use of Bootle Boot Camp
To explore physiotherapists, children, and their caregivers' experiences with the App.
Children with cerebral palsy (ages 6-12 years, GMFCS Level I or II) will be prescribed a home exercise program by their treating physiotherapist that they will complete independently using the App on their television at home. Bootle Boot Camp exercise sessions offered with movement-tracking feedback will be alternated with sessions offered without feedback for 4 weeks (4 sessions per week). Following this comparison period, the version of the App providing the most therapeutic data pattern based on system data and children's input will be used for an additional 2 weeks. Post 6 weeks of Bootle Boot Camp game play, children and caregivers will be asked to take part in semi-structured interviews to learn more about families' experiences with the home program
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Our study is a semi-randomized, non-blinded single case experimental design with alternating treatments. The comparison period will consist of Bootle Boot Camp exercise sessions offered with movement tracking feedback alternating with exercise sessions offered without this feedback (4 sessions per week x 4 week). Children will be randomized to 1 of 16 alternating treatment schedules. The version of the App providing the most therapeutic data pattern will be used for an additional two weeks.
We will also use a mixed methods sequential explanatory approach, with quantitative data collected in weeks 1-6 and qualitative data in weeks 7-8.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bootle Boot Camp with movement tracking feedback (virtual Coach Botley present)
Arm Type
Experimental
Arm Description
Bootle Boot Camp exercise sessions offered with movement tracking feedback through the presence of virtual coach Botley.
Arm Title
Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent)
Arm Type
Experimental
Arm Description
Bootle Boot Camp exercise sessions offered without movement tracking feedback through the absence of virtual coach Botley.
Intervention Type
Other
Intervention Name(s)
Bootle Boot Camp Home Exercise App - with Virtual Coach Botley
Intervention Description
Bootle Boot Camp exercise sessions offered with movement tracking feedback will be provided for a maximum of two consecutive sessions before being alternated with the no feedback condition for a period of 4 weeks (4 sessions/week). Movement feedback will be guided by skeletal data captured by the 3D motion tracking camera and based on predefined movement acceptability criteria for each exercise. Feedback will take the form of visual markers, text/audio cues and rewards.
Intervention Type
Other
Intervention Name(s)
Bootle Boot Camp Home Exercise App - without Virtual Coach Botley
Intervention Description
Bootle Boot Camp exercise sessions offered without movement tracking feedback will be provided for a maximum of two consecutive sessions before being alternated with the movement tracking feedback condition for a period of 4 weeks (4 sessions/week).
Primary Outcome Measure Information:
Title
Adherence (as a measure of behavioural engagement)
Description
The number of exercise repetitions that are attempted each session will be tracked and recorded by the 3D camera computer system and will be expressed as a proportion of the total number of prescribed repetitions
Time Frame
Week 1 - 6
Secondary Outcome Measure Information:
Title
Smileyometer Scale
Description
Children will rate their level of fun and how helpful they feel the game is for their body after each exercise session using customized Smileyometer rating scales. The Smileyometer scale is a 5-point smiley face rating scale with anchors of 1 relating to "Awful" and 5 to "Brilliant" that is used to measure product liking. Higher scores reflect greater experienced fun.
Time Frame
Week 1 - 6; Session 1 - 24
Title
Exercise fidelity
Description
The total acceptable repetition count (based on predefined movement quality criteria) for each exercise will be tracked and recorded by the 3D camera computer system and will be expressed as a proportion of the total number of prescribed repetitions.
Time Frame
Week 1 - 6; Session 1 - 24
Title
Bootle Boot Camp Acceptability Survey
Description
Children will rate perceived therapeutic effectiveness of each version of the App after the 4-week comparison period using the study-specific Bootle Boot Camp Acceptability Survey. The survey consists of questions with open-ended responses, rating agreement with statements (e.g., I had fun playing Bootle Boot Camp) on a 5-point rating scale with 1 representing 'disagree' to 5 representing 'agree,' and selecting which version of the App they feel best answers each question (e.g., which version of the game was most helpful for your body?)
Time Frame
4th week mark at session 16
Title
Five Time Sit to Stand Test
Description
The test measures the time needed to complete five consecutive sit to stand cycles as fast as possible as a measure of lower limb functional strength. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Time Frame
Week 1 at session 1 & Week 6 at session 21
Title
Modified Timed Up and Go
Description
The test measures the time in seconds to rise from a chair, walk 3m and return to sitting as a measure of functional mobility. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp.
Time Frame
Week 1 at session 2 & Week 6 at session 22
Title
One Leg Stance Test
Description
The test measures the time in seconds that a child can balance on one leg as a measure of standing stability. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Time Frame
Week 1 at session 3 & Week 6 at session 23
Title
Pediatric Reach Test
Description
The test measures the distance that a child can reach forward and sideways in standing and sitting as a measure of balance. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Time Frame
Week 1 at session 3 & Week 6 at session 23
Title
30 Second Sit to Stand Test
Description
The test measures the number of sit to stand cycles that a child can complete in 30 seconds as a measure of functional lower limb strength. Children will complete this test at the start and end of their six weeks of game play with Bootle Boot Camp
Time Frame
Week 1 at session 4 & Week 6 at session 24
Title
Mobile App Rating Scale
Description
Parents will complete the Mobile App Rating Scale (MARS) for each version of the game to assess each version's value and usability. The MARS assesses App quality through 5 subscales: engagement, functionality, aesthetics, information quality and subjective quality, with questions asked using 1-5 rating scales. An App quality mean score and App subjective quality score is reported. Higher scores denote more positive feelings towards the App.
Time Frame
Week 4 at session 16
Title
Canadian Occupational Performance Measure
Description
The Canadian Occupational Performance Measure (COPM) will be used to assess client's performance and satisfaction on self-identified goals pre and post six weeks of Bootle Boot Camp game play. Children rate performance and satisfaction on each activity using 10-point rating scales (minimum score 1 and maximum score 10) with higher scores reflecting higher performance and satisfaction. A change of at least 2 points has been considered clinically meaningful.
Time Frame
Week 0 and Week 7
Title
System Usability Scale and Bootle Boot Camp Usability Survey
Description
Physiotherapists will rate the usability of Bootle Boot Camp using the System Usability Scale (SUS) after they have used the App to prescribe a home exercise program to their client. The SUS is composed of 10 questions with SUS scores ranging from 0 to 100, with higher scores reflecting greater usability.
Time Frame
Week 0
Title
Pick-A-Mood
Description
Before each exercise session, children will be asked how they are feeling using Pick-A-Mood, a cartoon-based self-report scale with eight characters representing eight different mood states.
Time Frame
Week 1 - 6; Session 1 - 24
Title
Semi structured interviews
Description
Children and parents will be interviewed post 6-weeks of Bootle Boot Camp game play to understand families' experiences with using the App for home exercise program completion
Time Frame
Week 7 and Week 8
Title
Wong-Bakers Faces Pain Scale
Description
Before each exercise session, children will be asked to rate their level of pain using the Wong Bakers Faces Pain scale, ranging from no pain (score of 0) to the most pain possible (score of 5). Higher scores denote more pain.
Time Frame
Week 1 - 6; Session 1 - 24
Title
Study-specific Energy Level Question
Description
Before each exercise session, children will be asked to rate their level of energy using a study-specific energy level scale ranging from no energy (score of 0) to lots of energy (score of 10). Higher scores denote more energy.
Time Frame
Week 1 - 6; Session 1 - 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Physiotherapist Inclusion Criteria:
Registered and in good standing with the College of Physiotherapists of Ontario
Minimum 1-year pediatric clinical experience
Caseload consists of clients with cerebral palsy (ages 6-12 years; GMFCS Level I-II)
Works in public sector (Holland Bloorview) or private sector (clinics) within Ontario
Has technology (e.g., laptop) and internet services needed to use Bootle Boot Camp, complete online surveys and video calls
Has managerial and institutional approval
Physiotherapist Exclusion Criteria:
* Visual/auditory deficits that would limit the physiotherapist's ability to interact with the App
Child Inclusion Criteria:
Diagnosis of cerebral palsy (GMFCS Levels I-II)
Ages 6-12 years
Minimum 1 lower limb goal
Able to complete 4 weekly exercise sessions using Bootle Boot Camp for 6 weeks
Not currently receiving physiotherapy services more than once every two months (on an off block from physiotherapy)
Normal or corrected to normal vision and hearing
Child and parent can speak and understand English
Has technology (e.g., laptop) and internet services needed to use Bootle Boot Camp, complete online surveys, and video calls
Child's physiotherapist and parent able and willing to also participate in the study
Child Exclusion Criteria:
Botox injection in the last 6 weeks or orthopedic surgery in the last 6 months
Has serial casting, Botox injection, orthopedic surgery or other significant medical intervention during the 6-week training period with the App
Photosensitivity or unstable epilepsy triggered by video games, screen activities or TV light
Visual or auditory deficits that would limit gameplay
Respiratory, cardiovascular, or other significant medical condition that would limit safe gameplay
Engaging in a progressive lower limb muscle strengthening or balance home exercise program as prescribed by a health care provider
An extensive medical or therapeutic schedule (services scheduled on more than 3 days/week)
Scheduled event (e.g., family or school trip) that would limit ability to perform 4 sessions/week for 6 weeks during training period with the App
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Biddiss
Phone
416-425-6220
Ext
3505
Email
ebiddiss@hollandbloorview.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ajmal Khan
Phone
416-425-6220
Ext
3544
Email
akhan@hollandbloorview.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Biddiss
Organizational Affiliation
Bloorview Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Biddiss, PhD
Phone
4164256220
Ext
3505
Email
ebiddiss@hollandbloorview.ca
First Name & Middle Initial & Last Name & Degree
Ajmal Khan, MHSc
Phone
4164256220
Ext
3544
Email
akhan@hollandbloorview.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Home Exercise Program Using Bootle Boot Camp
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