Clinical trial NCT05998239: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. To compare participants' level of affective, behavioural, and cognitive engagement with Bootle Boot Camp with and without movement tracking feedback
2. To determine the quality of exercise performance when participants use Bootle Boot Camp with and without movement tracking feedback
3. To estimate the treatment response associated with use of Bootle Boot Camp
4. 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

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

Primary outcomes:
measure: Adherence (as a measure of behavioural engagement)
timeFrame: Week 1 - 6
Secondary outcomes:
measure: Smileyometer Scale
timeFrame: Week 1 - 6; Session 1 - 24
measure: Exercise fidelity
timeFrame: Week 1 - 6; Session 1 - 24
measure: Bootle Boot Camp Acceptability Survey
timeFrame: 4th week mark at session 16
measure: Five Time Sit to Stand Test
timeFrame: Week 1 at session 1 & Week 6 at session 21
measure: Modified Timed Up and Go
timeFrame: Week 1 at session 2 & Week 6 at session 22
measure: One Leg Stance Test
timeFrame: Week 1 at session 3 & Week 6 at session 23
measure: Pediatric Reach Test
timeFrame: Week 1 at session 3 & Week 6 at session 23
measure: 30 Second Sit to Stand Test
timeFrame: Week 1 at session 4 & Week 6 at session 24
measure: Mobile App Rating Scale
timeFrame: Week 4 at session 16
measure: Canadian Occupational Performance Measure
timeFrame: Week 0 and Week 7
measure: System Usability Scale and Bootle Boot Camp Usability Survey
timeFrame: Week 0
measure: Pick-A-Mood
timeFrame: Week 1 - 6; Session 1 - 24
measure: Semi structured interviews
timeFrame: Week 7 and Week 8
measure: Wong-Bakers Faces Pain Scale
timeFrame: Week 1 - 6; Session 1 - 24
measure: Study-specific Energy Level Question
timeFrame: Week 1 - 6; Session 1 - 24
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Bloorview Research Institute
name: Elaine Biddiss
role: PRINCIPAL_INVESTIGATOR
References: