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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
16
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 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).
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
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
Time frame: Week 1 - 6
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.
Time frame: 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.
Time frame: 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?)
Time frame: 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
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Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Week 1 - 6; Session 1 - 24