None listed
Conditions
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.
Interventions
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
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
Sponsors
Assoc Prof Peter Gray
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 6 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed