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Bike Skills Training for Children With Cerebral Palsy (CPBIKERCT)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Novel task-specific bike skills training program
Parent-led home-based bike skills training program
Sponsored by
Murdoch Childrens Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor learning, participation

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Live in Victoria, Australia
  • Diagnosis of cerebral palsy
  • Aged 6 - 15 years
  • Independently ambulant without mobility aids
  • Have goals specific to two-wheel bike skills
  • Have medical clearance to participate
  • Have access to an appropriate bike and helmet
  • Have a primary care giver who understands written and spoken English available to participate for each participant.

Exclusion Criteria:

  • Has a moderate to severe intellectual impairment
  • Has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. This includes; Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician
  • Had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
  • Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)

Sites / Locations

  • Monash Health
  • The Royal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel task-specific program

Parent-led home-based program

Arm Description

Intervention arm - see detailed intervention group description below

Comparison arm - see detailed comparison group description below

Outcomes

Primary Outcome Measures

Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2016
Last Updated
April 20, 2023
Sponsor
Murdoch Childrens Research Institute
Collaborators
University of Melbourne, Deakin University, Monash Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03003026
Brief Title
Bike Skills Training for Children With Cerebral Palsy
Acronym
CPBIKERCT
Official Title
Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Murdoch Childrens Research Institute
Collaborators
University of Melbourne, Deakin University, Monash Medical Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An assessor blinded multi-centre randomized controlled trial will be conducted in which 60 participants will be randomized to either a novel task-specific approach to training bike skills or a parent-led home program comparison group. Baseline assessment will take place within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The primary outcome is attainment of individualised two-wheel bike specific goals at T1. All statistical analysis will be conducted on an intention-to-treat basis. Logistic regression will be used to assess the effect of providing the novel intervention compared to the parent-led home program on bike-specific goal attainment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor learning, participation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Novel task-specific program
Arm Type
Experimental
Arm Description
Intervention arm - see detailed intervention group description below
Arm Title
Parent-led home-based program
Arm Type
Active Comparator
Arm Description
Comparison arm - see detailed comparison group description below
Intervention Type
Other
Intervention Name(s)
Novel task-specific bike skills training program
Intervention Description
Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.
Intervention Type
Other
Intervention Name(s)
Parent-led home-based bike skills training program
Intervention Description
The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.
Primary Outcome Measure Information:
Title
Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
Description
The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.
Time Frame
1 week following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Live in Victoria, Australia Diagnosis of cerebral palsy Aged 6 - 15 years Independently ambulant without mobility aids Have goals specific to two-wheel bike skills Have medical clearance to participate Have access to an appropriate bike and helmet Have a primary care giver who understands written and spoken English available to participate for each participant. Exclusion Criteria: Has a moderate to severe intellectual impairment Has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. This includes; Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician Had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis) Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel A Toovey, PT, MPH
Organizational Affiliation
Murdoch Childrens Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29431140
Citation
Toovey R, Harvey AR, McGinley JL, Lee KJ, Shih STF, Spittle AJ. Bike skills training for children with cerebral palsy: protocol for a randomised controlled trial. BMJ Open. 2018 Feb 3;8(2):e019898. doi: 10.1136/bmjopen-2017-019898.
Results Reference
background

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Bike Skills Training for Children With Cerebral Palsy

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