Cerebral PalsyNCT05998239
Home Exercise Program Using Bootle Boot Camp
A study testing Bootle Boot Camp Home Exercise App - with Virtual Coach Botley and Bootle Boot Camp Home Exercise App - without Virtual Coach Botley in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Bootle Boot Camp Home Exercise App - with Virtual Coach Botley and Bootle Boot Camp Home Exercise App - without Virtual Coach Botley
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2024to 31 Aug 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
Elaine Biddiss, PhD, 4164256220 ext. 3505, ebiddiss@hollandbloorview.ca
Ajmal Khan, MHSc, 4164256220 ext. 3544, akhan@hollandbloorview.ca
About this study
Official title: Testing Bootle Boot Camp - A New Movement Tracking App to Engage Kids in Home Exercise Programs
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.
Read the 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
- Conditions
- Cerebral Palsy
- Being tested
- Bootle Boot Camp Home Exercise App - with Virtual Coach Botley, Bootle Boot Camp Home Exercise App - without Virtual Coach Botley
- 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 Boot Camp Home Exercise App - with Virtual Coach BotleyOther
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.
Bootle Boot Camp Home Exercise App - without Virtual Coach BotleyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Bootle Boot Camp with movement tracking feedback (virtual Coach Botley present) | Experimental | Bootle Boot Camp exercise sessions offered with movement tracking feedback through the presence of virtual coach Botley. Receives: Other: Bootle Boot Camp Home Exercise App - with Virtual Coach Botley |
| Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent) | Experimental | Bootle Boot Camp exercise sessions offered without movement tracking feedback through the absence of virtual coach Botley. Receives: Other: Bootle Boot Camp Home Exercise App - without Virtual Coach Botley |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 1 - 6
Secondary outcomes (15)
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.
Measured: Week 1 - 6; Session 1 - 24
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.
Measured: Week 1 - 6; Session 1 - 24
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?)
Measured: 4th week mark at session 16
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
Measured: Week 1 at session 1 & Week 6 at session 21
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.
Measured: Week 1 at session 2 & Week 6 at session 22
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
Measured: Week 1 at session 3 & Week 6 at session 23
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
Measured: Week 1 at session 3 & Week 6 at session 23
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
Measured: Week 1 at session 4 & Week 6 at session 24
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.
Measured: Week 4 at session 16
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.
Measured: Week 0 and Week 7
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.
Measured: Week 0
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.
Measured: Week 1 - 6; Session 1 - 24
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
Measured: Week 7 and Week 8
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.
Measured: Week 1 - 6; Session 1 - 24
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.
Measured: Week 1 - 6; Session 1 - 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startJan 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Elaine Biddiss, Principal investigator, Bloorview Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998239
- Sponsor's protocol ID
- 0607
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrevska M, Wright FV, Khan A, Sert S, Ferreira I, Munce S, Fehlings D, Biddiss E. Lessons learned while exploring the impact of movement-tracking feedback on the experiences of children with neuromotor disorders taking part in interactive home exercise programs: a multi-case mixed methods study. J Neuroeng Rehabil. 2026 Feb 27;23(1):110. doi: 10.1186/s12984-025-01819-1.
PubMed 41761323Petrevska M, Wright FV, Khan A, Munce S, Fehlings D, Biddiss E. Evaluating the impact of movement tracking feedback on engagement with home exercise programmes of children with cerebral palsy using a new therapy app: a protocol for a mixed-methods single-case experimental design with alternating treatments. BMJ Open. 2024 Mar 18;14(3):e082761. doi: 10.1136/bmjopen-2023-082761.
PubMed 38503423
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Bootle Boot Camp - A New Movement Tracking App to Engage Kids in Home Exercise Programs
- ClinicalTrials.gov ID
- NCT05998239
- Acronym / sponsor ID
- 0607
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 18 Aug 2023 (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 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bootle Boot Camp with movement tracking feedback (virtual Coach Botley present) | Experimental | Other: Bootle Boot Camp Home Exercise App - with Virtual Coach BotleyBootle Boot Camp exercise sessions offered with movement tracking feedback through the presence of virtual coach Botley. |
| Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent) | Experimental | Other: Bootle Boot Camp Home Exercise App - without Virtual Coach BotleyBootle Boot Camp exercise sessions offered without movement tracking feedback through the absence of virtual coach Botley. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 Boot Camp Home Exercise App - with Virtual Coach BotleyBootle 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. | Other | Bootle Boot Camp with movement tracking feedback (virtual Coach Botley present) |
| Bootle Boot Camp Home Exercise App - without Virtual Coach BotleyBootle 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). | Other | Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent) |
Primary outcome
Adherence (as a measure of behavioural engagement)
Time frame: Week 1 - 6
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
15 secondary outcomes
Smileyometer Scale
Time frame: Week 1 - 6; Session 1 - 24
Exercise fidelity
Time frame: Week 1 - 6; Session 1 - 24
Bootle Boot Camp Acceptability Survey
Time frame: 4th week mark at session 16
Five Time Sit to Stand Test
Time frame: Week 1 at session 1 & Week 6 at session 21
Modified Timed Up and Go
Time frame: Week 1 at session 2 & Week 6 at session 22
One Leg Stance Test
Time frame: Week 1 at session 3 & Week 6 at session 23
Pediatric Reach Test
Time frame: Week 1 at session 3 & Week 6 at session 23
30 Second Sit to Stand Test
Time frame: Week 1 at session 4 & Week 6 at session 24
Mobile App Rating Scale
Time frame: Week 4 at session 16
Canadian Occupational Performance Measure
Time frame: Week 0 and Week 7
System Usability Scale and Bootle Boot Camp Usability Survey
Time frame: Week 0
Pick-A-Mood
Time frame: Week 1 - 6; Session 1 - 24
Semi structured interviews
Time frame: Week 7 and Week 8
Wong-Bakers Faces Pain Scale
Time frame: Week 1 - 6; Session 1 - 24
Study-specific Energy Level Question
Time frame: Week 1 - 6; Session 1 - 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 41761323Petrevska M, Wright FV, Khan A, Sert S, Ferreira I, Munce S, Fehlings D, Biddiss E. Lessons learned while exploring the impact of movement-tracking feedback on the experiences of children with neuromotor disorders taking part in interactive home exercise programs: a multi-case mixed methods study. J Neuroeng Rehabil. 2026 Feb 27;23(1):110. doi: 10.1186/s12984-025-01819-1.
- Derived from this study: PubMed 38503423Petrevska M, Wright FV, Khan A, Munce S, Fehlings D, Biddiss E. Evaluating the impact of movement tracking feedback on engagement with home exercise programmes of children with cerebral palsy using a new therapy app: a protocol for a mixed-methods single-case experimental design with alternating treatments. BMJ Open. 2024 Mar 18;14(3):e082761. doi: 10.1136/bmjopen-2023-082761.
- Individual participant dataSharing planned: No
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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 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 Boot Camp Home Exercise App - with Virtual Coach Botley and Bootle Boot Camp Home Exercise App - without Virtual Coach Botley in people with 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?
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: status not confirmed, as of the sponsor's last update on 8 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Biddiss (416-425-6220 ext. 3505, ebiddiss@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (as a measure of behavioural engagement) (time frame: Week 1 - 6). 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 NCT05998239, which also lists 2 linked publications.
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 8 Dec 2023.