NCT05998239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 8, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

July 25, 2023

Last Update Submit

December 6, 2023

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Smileyometer Scale

    Week 1 - 6; Session 1 - 24

  • Exercise fidelity

    Week 1 - 6; Session 1 - 24

  • Bootle Boot Camp Acceptability Survey

    4th week mark at session 16

  • Five Time Sit to Stand Test

    Week 1 at session 1 & Week 6 at session 21

  • Modified Timed Up and Go

    Week 1 at session 2 & Week 6 at session 22

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Other: Bootle Boot Camp Home Exercise App - without Virtual Coach Botley

Interventions

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 with movement tracking feedback (virtual Coach Botley present)
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).

Bootle Boot Camp without movement tracking feedback (virtual Coach Botley absent)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \* Visual/auditory deficits that would limit the physiotherapist's ability to interact with the App
  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

  • Petrevska 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.

    PMID: 38503423DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Elaine Biddiss

    Bloorview Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Biddiss

CONTACT

416-425-6220ebiddiss@hollandbloorview.ca

Ajmal Khan

CONTACT

416-425-6220akhan@hollandbloorview.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 18, 2023

Study Start

January 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

December 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)