Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000126112
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
29/01/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobility skills programme for children with cerebral palsy
Scientific title
The effect of a high-level mobility skills training programme
on sustained community participation in physical activity of ambulant children with cerebral palsy.
Secondary ID [1] 297086 0
None
Universal Trial Number (UTN)
U1111-1226-8425
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 311093 0
physical activity 311094 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309726 309726 0 0
Physiotherapy
Neurological 309775 309775 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research is concerned with the ability of ambulant children with cerebral palsy to take part, and sustain their participation, in community-based physical activities. The included children with cerebral palsy will be able to walk with and without walking aids and will participate in a programme designed to improve their running and high-level mobility skills such as jumping, hopping and skipping. The programme will be run as a community group based programme at a local park and school. Each child's goals and programme will be individualised. The group will be run by an experienced paediatric physiotherapist (28 years of physiotherapy) and a trainer who is skilled in training children. The programme will focus on participation attendance and involvement in a high-level mobility programme (HLMP) for three months, and the extent to which participation in community-based physical activities of their choice for a further six months is sustained, will be assessed. Community activities will include those done at home, school or wider community, but not therapy-based activities. The children will keep a diary of their physical activities. There will be fitness and participation outcome measures tested at baseline, before and after the high level mobility programme intervention and after 6 months of follow up.
The research will be run as a SCED - single case experimental design with multiple baselines. Each child will attend 2 sessions per week of the programme during the intervention phase for 3 months. Each session will last 1 hour and be targeted at each child's ability and self selected goals. The programme will use rebounders, agility ladders, small hurdles, cones and balls. It is anticipated that such a programme may support the children’s medium to long term health and well being.
The aim is to recruit eight children with cerebral palsy. The children will be placed into two groups based on cerebral palsy mobility classification - gross motor functional classification system (GMFCS). This will form the treatment fidelity. One group of 4 children will be classified GMFCS I - able to mobilise independently over all surfaces but lack high level motor skills of their typically developing peers and the second group GMFCS II - walks without assistive devise but has limitations in walking outdoors, in the community and requires a rail for stairs. To improve fidelity, both groups will begin the baseline phase at different times eg, group 2 months after group 1. Each child will then follow their own course through the SCED based on their individualised goals and time to reach baseline (stable physical activity participation). The fidelity will be assessed and determined by the principal investigator.
Intervention code [1] 313361 0
Lifestyle
Comparator / control treatment
Each child is their own control due to SCED - single case experimental design
Control group
Active

Outcomes
Primary outcome [1] 318694 0
The primary outcome will be physical activity participation, as measured by attendance and involvement, using the GAS - Goal Attainment Scale. Such a goal may be "to join a basketball team and attend basketball practise 1x/week following the intervention phase". Goals will be set by each child, with the assistance of their family as needed, at baseline for participation in physical activity and physical activity performance goals.
Timepoint [1] 318694 0
The participation goals will be reassessed every second week throughout the study period eg. baseline (1-3 months), intervention phase (2x/week training for 3 months) and follow up phase for 6 months. The goals will be compared from baseline to end of study achievements (6 months post intervention phase) using the ordinal GAS scale of -2 unable to do to +2 achieved beyond expectations.
Secondary outcome [1] 365744 0
Physical activity performance goal(s) will also be assessed using the GAS - Goal Attainment Scale. Such a goal may include "to run 1 km without stopping and under 7 minutes by the end of the study".
Timepoint [1] 365744 0
The physical activity performance goals will be reassessed every second week throughout the study period eg. baseline (1-3 months), intervention phase (2x/week training for 3 months) and follow up phase for 6 months. The goals will be compared from baseline to end of study achievements (6 months post intervention phase) using the ordinal GAS scale of -2 unable to do to +2 achieved beyond expectations.
Secondary outcome [2] 367113 0
High Level Mobility outcome of change in gait and running "form" as per review of video footage - 20 m runway 2D videoing on sagittal and coronal plane
Timepoint [2] 367113 0
All high level mobility measures will be tested at baseline, pre intervention, post intervention and at the 6 months follow up point. Childrens results will be compared to their own results as each phase of the research.
Secondary outcome [3] 367114 0
High level mobility outcome of anaerobic muscle power will be assessed using MPST - Muscle power sprint test. 6 x 15 m sprints timed with 10 rest in between. Outcome is time in seconds and Peak and mean power calculated as Watts.
Timepoint [3] 367114 0
All high level mobility measures will be tested at baseline, pre intervention, post intervention and at the 6 months follow up point. Childrens results will be compared to their own results as each phase of the research.
Secondary outcome [4] 367115 0
High level mobility outcome of aerobic fitness will also be tested using the Modified 10 shuttle run test which is standardised for children with cerebral palsy.
The level increments progressively becoming faster and the child's level and total number of shuttles are recorded
Timepoint [4] 367115 0
Measured at baseline, pre intervention, post intervention and at the study end at 6 months. Each child's results will be compared to their own at each study phase.
Secondary outcome [5] 367116 0
High level mobility outcome for agility using the 10 x 5m sprint test. Children complete 10 x 5m continuous sprint between cones. Timed in seconds.
Timepoint [5] 367116 0
Measured at baseline, pre and post intervention and at the follow up phase at 6 months.
Secondary outcome [6] 367117 0
High level mobility outcome for functional capacity using HiMAT - High level mobility assessment tool. 13 tests for high level mobility and balance. Outcome as a total score using time, distance and number for the specific tests.
Timepoint [6] 367117 0
HiMAT outcomes at baseline, pre and post intervention and at follow 6 months post intervention.

Eligibility
Key inclusion criteria
Children with cerebral palsy aged 7-18 years
Ambulant - can walk 10 m independently and climb 6 stairs with or without a rail
Can follow instructions and set goals
Can commit to programme time frame - up to 1 year from baseline to end of follow up phase
Medical clearance from GP or physiotherapist
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to follow instructions
Behaviour that is not conducive to group setting and setting/working towards goals
Unable to commit to time frame
Any medical condition in the past 6 months that would prevent/contradict exercising
Any multilevel orthopaedic surgery in the past 1 year

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
SCED design (single case experimental design) - no randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
SCED design - each child acts as their own controls.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 21201 0
New Zealand
State/province [1] 21201 0
Canterbury

Funding & Sponsors
Funding source category [1] 301653 0
Government body
Name [1] 301653 0
NHMRC funded grant from CRE-CP Centre of Research Excellence in Cerebral Palsy
Country [1] 301653 0
Australia
Primary sponsor type
Individual
Name
Gaela Kilgour
Address
Faculty of Health Science
St Patricks Building 460
Level 8
250 Victoria Parade
East Melbourne
VIC 3002
Australia
Country
Australia
Secondary sponsor category [1] 301365 0
Individual
Name [1] 301365 0
Professor Christine Imms
Address [1] 301365 0
Director Centre for Disability and Development Research, Australian Catholic University, Level 2, Daniel Manix Building, 17 Young Street, Fitzroy, VIC. 3065

Locked Bag 4115, Fitzroy VIC. 3065
Country [1] 301365 0
Australia
Secondary sponsor category [2] 301812 0
Individual
Name [2] 301812 0
Dr Michael Steele
Address [2] 301812 0


Senior Lecturer in Biostatistics

School of Allied Health | Faculty of Health Sciences

Australian Catholic University

Room 203.1.08

1100 Nudgee Road, Banyo QLD 4014

PO Box 456, Virginia QLD 4014
Country [2] 301812 0
Australia
Secondary sponsor category [3] 301813 0
Individual
Name [3] 301813 0
Professor Ngaire Susan Stott
Address [3] 301813 0
AUCKLAND HOSPITAL - Bldg 599
Level 12, Room 12091
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country [3] 301813 0
New Zealand
Secondary sponsor category [4] 301814 0
Individual
Name [4] 301814 0
Dr Brooke Adair
Address [4] 301814 0
Australian Catholic University, Level 2, Daniel Manix Building, 17 Young Street, Fitzroy, VIC. 3065

Locked Bag 4115, Fitzroy VIC. 3065
Country [4] 301814 0
Australia
Secondary sponsor category [5] 301815 0
Individual
Name [5] 301815 0
Dr Amy Hogan
Address [5] 301815 0
CP Society, 8 Railway St, Newmarket , Auckland 1023, New Zealand
Country [5] 301815 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302374 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 302374 0
Ethics committee country [1] 302374 0
New Zealand
Date submitted for ethics approval [1] 302374 0
17/01/2019
Approval date [1] 302374 0
08/02/2019
Ethics approval number [1] 302374 0
Reference: 19/STH/22 Submission code: NZ/1/E6E118

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90006 0
Mrs Gaela Kilgour
Address 90006 0
Australian Catholic University
Faculty of Health Science
St Patricks Building 460
Level 8
250 Victoria Parade
East Melbourne
VIC 3002
Australia
Country 90006 0
Australia
Phone 90006 0
+613 99533753
Fax 90006 0
Email 90006 0
[email protected]
Contact person for public queries
Name 90007 0
Gaela Kilgour
Address 90007 0
Australian Catholic University
Faculty of Health Science
St Patricks Building 460
Level 8
250 Victoria Parade
East Melbourne
VIC 3002
Australia
Country 90007 0
Australia
Phone 90007 0
+613 99533753
Fax 90007 0
Email 90007 0
[email protected]
Contact person for scientific queries
Name 90008 0
Gaela Kilgour
Address 90008 0
Australian Catholic University
Faculty of Health Science
St Patricks Building 460
Level 8
250 Victoria Parade
East Melbourne
VIC 3002
Australia
Country 90008 0
Australia
Phone 90008 0
+613 99533753
Fax 90008 0
Email 90008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The aim is to recruit 8 participants for this SCED - single case experimental design. Each child's data will be de-identified. Individual participation and physical performance goals will be shared and their results from baseline, intervention through to follow up phase and end of the study to show change.
When will data be available (start and end dates)?
Data is expected to be available directly after publication. No end date determined.
Available to whom?
Case by case at the discretion of the Principal Investigator
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23718Informed consent form    376737-(Uploaded-05-05-2020-11-53-29)-Study-related document.doc

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3860Basic resultsNo 376737-(Uploaded-06-01-2022-21-27-34)-Basic results summary.docx
4114Plain language summaryNo The systematic review included 11 randomised contr... [More Details]
4745Study results articleYes Gaela Kilgour, Brooke Adair, Ngaire Susan Stott, M... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Journey to Sustainable Participation in Physical Activity for Adolescents Living with Cerebral Palsy.2023https://dx.doi.org/10.3390/children10091533
N.B. These documents automatically identified may not have been verified by the study sponsor.