Home Exercise Program Using Bootle Boot Camp

Cerebral Palsy Clinical Trial

Official title:

Testing Bootle Boot Camp - A New Movement Tracking App to Engage Kids in Home Exercise Programs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998239
• Other study ID #: 0607
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Elaine Biddiss
• Phone: 416-425-6220
• Email: ebiddiss[@]hollandbloorview.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Bootle Boot Camp Home Exercise App - with Virtual Coach Botley
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 Botley
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).

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 1 - 6
Secondary	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.	Week 1 - 6; Session 1 - 24
Secondary	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.	Week 1 - 6; Session 1 - 24
Secondary	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?)	4th week mark at session 16
Secondary	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	Week 1 at session 1 & Week 6 at session 21
Secondary	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.	Week 1 at session 2 & Week 6 at session 22
Secondary	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	Week 1 at session 3 & Week 6 at session 23
Secondary	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	Week 1 at session 3 & Week 6 at session 23
Secondary	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	Week 1 at session 4 & Week 6 at session 24
Secondary	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.	Week 4 at session 16
Secondary	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.	Week 0 and Week 7
Secondary	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.	Week 0
Secondary	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.	Week 1 - 6; Session 1 - 24
Secondary	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	Week 7 and Week 8
Secondary	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.	Week 1 - 6; Session 1 - 24
Secondary	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.	Week 1 - 6; Session 1 - 24