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Trial registered on ANZCTR


Registration number
ACTRN12613000950763
Ethics application status
Approved
Date submitted
12/08/2013
Date registered
27/08/2013
Date last updated
10/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of physiotherapy intervention compared to no intervention in pre-school children born extremely preterm.
Scientific title
Physiotherapy intervention to improve motor co-ordination, postural stability and behaviour in pre-school children born extremely preterm or with extremely low birth weight: a randomised controlled trial.
Secondary ID [1] 282983 0
1854 - Mater Research Registry, Mater Health Services
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extremely premature/extremely low birth weight children 289812 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290159 290159 0 0
Physiotherapy
Public Health 290160 290160 0 0
Health service research
Reproductive Health and Childbirth 290288 290288 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will consist of a group-based physiotherapy intervention program designed to target motor co-ordination, balance, postural stability and behaviour. The program will be led by a physiotherapist and will include 6 structured physiotherapy sessions that occur on a weekly basis for 6 weeks. Sessions will be progressed in terms of complexity and will be tailored to each child's specific needs. Each session will be 1-1.5 hours in duration. Parents and children will be given a weekly home exercise program and this will be progressed in association with the intervention program. Parents will be encouraged to spend 20-30 minutes on the home exercise program per day for the 6 weeks. If parents prefer, they are advised that the 20-30 minute home program may be undertaken in smaller blocks of time tather than doing the exercises in one continuous block of time. On the weekly home exercise program handout, there is a table for parents to record (with involvement of the child) of the the exercises that have been completed each dayThere will be 3-4 children per intervention group. Upon completion of the program, parents will be provided with a booklet of general age-appropriate activities to continue with their child. Email/telephone contact will be made with families every 2 months, at which time parents will be asked questions about their child's activities and will be provided with an opportunity to highlight any concerns that they may have about their child. the 2 monthly email/telephone contact will continue for 12 months post baseline assessment
Intervention code [1] 287696 0
Treatment: Other
Comparator / control treatment
The control children will receive 'usual care', although the parents will be provided with a booklet of age-appropriate activities. 'Usual care' for able-bodied extremely preterm or extremely low birth weight children translates to minimal if any support services for these children who have mild neurodevelopmental impairments. However, children in both the control and intervention groups may be referred for and receive other therapies by other health professional as deemed appropriate. The content of these therapies (if any0 will be recorded.Email/telephone contact will be made with the families every 2 months at which time parents will be asked questions about their child's activities and will be provided with an opportunity to highlight any concerns that they may have about their child. The 2 monthly email/telephone contact will continue for 12 months post baseline assessment
Control group
Active

Outcomes
Primary outcome [1] 290190 0
1. Motor co-ordination as measured by the Movement Assessment Battery for Children-2 (MABC-2).
Timepoint [1] 290190 0
At baseline (prior to the children in the intervention group commencing the program), after the children in the intervention group complete the program and then again 12 months post baseline assessment.
Secondary outcome [1] 304075 0
Postural control and balance assessed using the Timed Single Leg Stand and Lateral Reach Tests.
Timepoint [1] 304075 0
At baseline (prior to the children in the intervention group commencing the program), after the children in the intervention group complete the program and then again 12 months post baseline assessment.
Secondary outcome [2] 304076 0
Lower limb strength and control measured using the Standing Long Jump.
Timepoint [2] 304076 0
At baseline (prior to the children in the intervention group commencing the program), after the children in the intervention group complete the program, and then again 12 months post baseline assessment.
Secondary outcome [3] 304077 0
Visual motor deficits as assessed using the Beery Visual-Motor Integration (VMI) Test 5th Edition.
Timepoint [3] 304077 0
At baseline (prior to the children in the intervention group commencing the program) and then again 12 months post baseline assessment.
Secondary outcome [4] 304078 0
Behaviour measured using the Strengths and Difficulties Questionnaire (SDQ) and the Child Behaviour Checklist (CBCL) for Preschool Children.
Timepoint [4] 304078 0
At baseline (prior to the children in the intervention group commencing the program) and then at 12 months post baseline assessment.
Secondary outcome [5] 304079 0
Parental perception of a child's development assessed using the Parent's Evaluation of Developmental Status (PEDS).
Timepoint [5] 304079 0
At baseline (prior to the children in the intervention group commencing the program) and then at 12 months post baseline assessment.
Secondary outcome [6] 304080 0
Verbal and language skills measured using The Peabody Picture Vocabulary Test 4th Edition (PPVT-4).
Timepoint [6] 304080 0
12 months post baseline assessment.

Eligibility
Key inclusion criteria
The participants will have been born less than 1000g or less than 28 weeks gestational age and will have been managed in the Neonatal Intensive Care Unit at the Mater Mothers' Hospital, Brisbane, Australia. Children will be aged 4-4.5 years corrected for prematurity when commencing involvement in the study and will not have started their preparatory (prep) year of schooling.
Included children will have attended their 4 year (corrected age) Growth and Development Clinic follow-up assessment and will have a score from the Neurosensory Motor Developmental Assessment (NSMDA) of 9 to <13 and an IQ of >70 on the Stanford Binet Intelligence Scales. Children will also live within one hour of travel time to the Mater Hospitals.
Minimum age
4 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with significant congenital anomalies, diagnosed neurological impairments including cerebral palsy, a visual impairment not corrected by wearing corrective lenses or a hearing impairment not corrected by aids will be excluded from the study. Additionally, children will not participate if their parents/carers do not speak English, as delivery of the program including follow-up telephone calls would not be practical. Children of families who identify that they would not be able to commit to attending a 6 week physiotherapy program and returning for follow-up assessments will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children will be assessed for eligibility to participate in the study after they have completed their 4 year (corrected age) assessment at the Growth and Development Clinic. Eligibility to participate in the study will be determined by physiotherapy and psychology staff at the Growth and Development Clinic prior to enrollment. Parents of eligible children will be contacted by telephone to determine whether or not they wish to receive by mail the "Participant Information Sheet' and 'Consent Form' detailing the trial. Once consent has been obtained, children will be stratified according to their cognitive abilities.
Randomisation to either the intervention or control group will be concealed by using sealed opaque envelopes, identified by stratification group and consecutively numbered. These envelopes will be assigned to participants based on the order in which they are booked in for baseline assessment. Following baseline assessment, the physiotherapist providing the intervention will notify parents/carers by telephone to which group their child has been randomised. The physiotherapist leading the intervention will not have reviewed baseline assessment results of the children when advising parents/carers to which group their child has been randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of children into either the intervention or the control group will be performed using the computerised randomisation service provided by the Mater Mothers' Research Centre. Twins will be randomised to the same group due to the nature of the intervention.
Stratification will occur according to the child's cognitive abilities obtained from the Stanford Binet Intelligence scales at their 4 year (corrected age) assessment at the Growth and Development Clinic, with an IQ < or = to 85 / >85.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1425 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 7258 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 287756 0
Charities/Societies/Foundations
Name [1] 287756 0
Mater Foundation, Mater Health Services
Address [1] 287756 0
Raymond Tce, South Brisbane, Qld 4101
Country [1] 287756 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Peter Gray
Address
Growth and Development Unit, Mater Mothers' Hospital, Raymond Tce, South Brisbane, Qld 4101.
Country
Australia
Secondary sponsor category [1] 286478 0
Individual
Name [1] 286478 0
Assoc Prof Yvonne Burns (PhD, MPhty, Dip Physiot)
Address [1] 286478 0
Research Consultant, Growth and Development Unit, Mater Mothers' Hospital, Raymond Tce, South Brisbane, Qld 4101.
Country [1] 286478 0
Australia
Secondary sponsor category [2] 286480 0
Individual
Name [2] 286480 0
Assoc Prof Michael O'Callaghan
Address [2] 286480 0
Growth and Development Unit, Mater Mothers' Hospital, Raymond Tce, South Brisbane, Qld 4101.
Country [2] 286480 0
Australia
Secondary sponsor category [3] 286481 0
Individual
Name [3] 286481 0
Ms Laura Brown
Address [3] 286481 0
Dept of Physiotherapy, Mater Children's Hospital, Raymond Tce, South Brisbane, Qld 4101.
Country [3] 286481 0
Australia
Secondary sponsor category [4] 286482 0
Individual
Name [4] 286482 0
Dr Pauline Watter
Address [4] 286482 0
School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Qld 4072.
Country [4] 286482 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289703 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 289703 0
Mater Health Services, Raymond Tce, South Brisbane, Qld 4101.
Ethics committee country [1] 289703 0
Australia
Date submitted for ethics approval [1] 289703 0
Approval date [1] 289703 0
01/04/2010
Ethics approval number [1] 289703 0
1496C
Ethics committee name [2] 289704 0
Medical Research Ethics Committee
Ethics committee address [2] 289704 0
University of Queensland, St Lucia, Qld 4072
Ethics committee country [2] 289704 0
Australia
Date submitted for ethics approval [2] 289704 0
Approval date [2] 289704 0
23/04/2010
Ethics approval number [2] 289704 0

Summary
Brief summary
The purpose of the study is to investigate the effect of a physiotherapy intervention program with able-bodied 4 year old children born extremely preterm or with extremely low birth weight on their motor co-ordination, postural stability and functional performance compared to no intervention. Also the study will examine the impact of the intervention on behaviour.
OBJECTIVES
1. To evaluate the movement benefits of a specifically developed 6 week small group physiotherapy intervention program for children aged 4-4.5 years.
2. To compare the motor development of children with and without intervention.
3. To evaluate the impact of intervention compared to no intervention on general abilities, activity levels and behaviour 12 months post baseline assessment.
HYPOTHESES
It is hypothesised that a physiotherapy intervention program will improve motor co-ordination, postural stability and functional performance in 4 year old children born extremely preterm or with extremely low birth weight. It is hypothesised that improvements in motor abilities amongst this group of children will have a positive effect on activity levels and behaviour compared to children who receive no intervention. Furthermore, it is hypothesised that there is a close link between motor performance and the ability to cope with social interactions and that early improvement will continue to impact on the child's motor development, attention and behaviour, not just in the short term but will have long term effects.
Trial website
Trial related presentations / publications
Brown L, Burns YR, Watter P, Gray P (2012). Physiotherapy to improve motor co-ordination in Extremely Low Birth Weight (ELBW) preschool children: a randomised controlled trial. Dev Med Child Neurol, 54 (Suppl 5) 67.
Public notes

Contacts
Principal investigator
Name 42046 0
A/Prof Yvonne Burns
Address 42046 0
Growth and Development Unit, Mater Mothers' Hospital, Raymond Tce, South Brisbane, Qld 4101.
Country 42046 0
Australia
Phone 42046 0
+ 61731638849
Fax 42046 0
Email 42046 0
y.burns@uq.edu.au
Contact person for public queries
Name 42047 0
Ms Laura Brown
Address 42047 0
Dept of Physiotherapy, Raymond Tce,Mater Children's Hospital, South Brisbane, Qld 4101.
Country 42047 0
Australia
Phone 42047 0
+61731638585
Fax 42047 0
Email 42047 0
laurzjb@hotmail.com
Contact person for scientific queries
Name 42048 0
A/Prof Yvonne Burns
Address 42048 0
Growth and Development Unit, Mater Mothers' hospital, Raymond tce, South Brisbane, Qld 4101.
Country 42048 0
Australia
Phone 42048 0
+61731638849
Fax 42048 0
Email 42048 0
y.burns@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary