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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

24/01/2025

Date data sharing statement initially provided

29/01/2019

Date results provided

24/01/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Mobility skills programme for children with cerebral palsy

Scientific title

Effect of a high-level mobility skills training programme on sustained community participation in physical activity among ambulant children with cerebral palsy

Secondary ID [1]

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

physical activity

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

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 nine 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 physical performance and participation outcome measures tested at baseline, before and after the high level mobility programme intervention and after 6 months of follow up for physical performance and 9 months for participation.
The research will be run as a SSRD - single subject research 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. Each child will then follow their own course through the SSRD based on their individualised goals.

Intervention code [1]

Lifestyle

Comparator / control treatment

Each child is their own control using Single Subject Research Design.

Control group

Active

Outcomes

Primary outcome [1]

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]

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 9 months. The goals will be compared from baseline to end of study achievements (9 months post intervention phase) using the ordinal GAS scale of -2 unable to do to +2 achieved beyond expectations.

Secondary outcome [1]

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]

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 9 months. The goals will be compared from baseline to end of study achievements (9 months post intervention phase) using the ordinal GAS scale of -2 unable to do to +2 achieved beyond expectations.

Secondary outcome [2]

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]

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]

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]

Secondary outcome [4]

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]

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]

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]

Measured at baseline, pre and post intervention and at the follow up phase at 6 months.

Secondary outcome [6]

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]

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?

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)

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

Single Subject Research Design (SSRD) - each child acts as their own control

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/07/2019

Actual

8/08/2019

Date of last participant enrolment

Anticipated

Actual

30/08/2019

Date of last data collection

Anticipated

Actual

31/10/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC funded grant from CRE-CP Centre of Research Excellence in Cerebral Palsy

Country [1]

Australia

Primary sponsor type

Individual

Name

Gaela Kilgour

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Christine Imms

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Michael Steele

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Professor Ngaire Susan Stott

Country [3]

New Zealand

Secondary sponsor category [4]

Individual

Name [4]

Dr Brooke Adair

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Ms Amy Hogan

Country [5]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

New Zealand Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

17/01/2019

Approval date [1]

08/02/2019

Ethics approval number [1]

Reference: 19/STH/22 Submission code: NZ/1/E6E118

Ethics committee name [2]

Australian Catholic University

Ethics committee address [2]

115 Victoria Parade, Fitzroy VIC 3065, Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

20/03/2019

Approval date [2]

16/07/2019

Ethics approval number [2]

ACU Ethics Register Number : 2019-49R

Ethics committee name [3]

Canterbury Canterbury District Health Board Research Office

Ethics committee address [3]

2 Riccarton Avenue
PO Box 4345
Christchurch 8140
New Zealand

Ethics committee country [3]

New Zealand

Date submitted for ethics approval [3]

28/01/2019

Approval date [3]

14/03/2019

Ethics approval number [3]

19/STH/22

Summary

Brief summary

Physical activity participation in persons with a disability; specifically children with cerebral palsy in this research, is extremely important as we know such children currently do not meet minimum physical activity guidelines. Even the most able children with cerebral palsy are sedentary and they have greater health risk factors into adulthood than their typically developing peers. The development and attainment of high level mobility skills such as running, agility exercises and jumping, may particularly support children with cerebral palsies participation in physical activities in areas the of attendance and involvement, within the community.

The lack of evidence for physical activity interventions in cerebral palsy and poor translation to increasing participation, reinforces the need to change our interventions from an impairment-based focus to activity and participation focus. The complexity of participation and the need for new knowledge particularly in the area of involvement is essential to promote physical activity for life. Long term focus needs to shift to sustained participation, for it can be considered the ultimate health and educational outcome and the desired goal of rehabilitation (Whiteneck and Diejkers, 2009).


The current research will focus on improving the activities of running and high level mobility skills to enhance potential participation in the form of attendance and involvement, in any physical activity of each child's choice. The study provide a 3 month intervention of high level mobility skills training for 8 ambulant children with cerebral palsy following a SSRD design (single subject research design). Each child will set physical and participation goals. Children will be followed up for 9 months post intervention to investigate if participation has been sustained.

Research questions

1. Does a community based high level mobility programme (HLMP) improve the physical activity performance of children with cerebral palsy?

2. Does participation attendance and involvement in sport or other physical activity change following the HLMP?

3. To what extent do participants achieve sustained physical activity participation following completion of a community-based HLMP?

Trial website

Public notes

Contacts

Principal investigator

Name

Mrs Gaela Kilgour

Address

Department of Paediatrics, Reception Level 2, West Building Royal Children's Hospital 50 Flemington Road Parkville, Victoria 3052

Country

Australia

Phone

+64 22375 7065

Fax

gaela.kilgour@student.unimelb.edu.au

Contact person for public queries

Name

Gaela Kilgour

Address

Department of Paediatrics, Reception Level 2, West Building Royal Children's Hospital 50 Flemington Road Parkville, Victoria 3052

Country

Australia

Phone

+64 22375 7065

Fax

gaela.kilgour@student.unimelb.edu.au

Contact person for scientific queries

Name

Gaela Kilgour

Address

Department of Paediatrics, Reception Level 2, West Building Royal Children's Hospital 50 Flemington Road Parkville, Victoria 3052

Country

Australia

Phone

+64 22375 7065

Fax

gaela.kilgour@student.unimelb.edu.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case by case at the discretion of the Principal Investigator

Conditions for requesting access:
• -

What individual participant data might be shared?

• The aim is to recruit 8 participants for this SSRD - single subject research 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.

What types of analyses could be done with individual participant data?

• To achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
Data is expected to be available directly after publication. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Information from the study will be kept secure in a locked filing cabinet accessible only by the investigators for 10 years after the age of majority (i.e. after your child is 26 years old).
Access to any other information regarding the research project will be subject to approval after contacting the Principal Investigator via email gaela.kilgour@student.unimelb.edu.au and same contact phone number.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23718	Informed consent form					Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Journey to Sustainable Participation in Physical Activity for Adolescents Living with Cerebral Palsy.	2023	https://dx.doi.org/10.3390/children10091533

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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