Small Step Intervention for Infants With Cerebral Palsy and Other Neurodevelopmental Disorders
Small Step Intervention for Infants With Cerebral Palsy and Other Neurodevelopmental Disorders
Children with cerebral palsy (CP) have life-long motor disorders and are typically subjected
 to extensive treatment throughout childhood. Despite this there is a lack of evidence
 supporting the effectiveness of treatment aiming at improving motor function and activity in
 daily life. The primary area of interest of this research programme is to determine the
 effectiveness of an early intervention program in children younger than 12 months of age who
 are at risk of developing CP. A randomised control trial is planned, addressing hand use,
 mobility and communication in a home-based program. New treatment principles based on recent
 knowledge of brain plasticity will be employed.

 The overarching goal of this research programme is to develop and evaluate new intervention
 principles for children with neurodevelopmental disorders based upon theories of early
 learning induced brain plasticity. Our overall aims can be formulated as follows:

 To evaluate the effects of an early intervention programme on the overall development in
 children with risk of developing cerebral palsy and other neurodevelopmental disorders. The
 program includes intensive intervention towards the foci: hand use, mobility and
 communication in a home based program

 The hypothesis is that the design of the Small-Step-Program intervention, with clear foci on
 specific areas of development during different time periods and conducted in the child's home
 environment, will facilitate development and be more effective than usual care.

 The second hypothesis is that children learn what they practice, meaning that children will
 have a more rapid development within the focus of each specific step in the training, when
 compared to the, for the time being, untrained steps.

 The third hypothesis is that children's ability to learn within the different steps of the
 intervention programme will be influenced by the specific characteristics of any underlying
 brain pathology.

 The fourth hypothesis is that parents in the study group will be less stressed and can better
 cope with their child's situation than parents to children receiving usual care. Thus, the
 tools provided within the Small-Step-Program intervention, like education, supervision and
 feedback of how to practice communication and task performance will make parents more able to
 cope with the child's delayed development.
Rational for subject selection: Signs of CP may be visible already during the first months,
 but according to recommendations the diagnosis of CP should typically not be made until 2-4
 years of age. The reason is that the individual developmental trajectories of muscle tone,
 postural control and motor function vary considerably during the first two years. A child
 with a late development may recover and atypical signs may disappear, and opposite, CP may
 develop although there have been no early signs. Thus, there is a dilemma in that it is too
 late to wait with early intervention until the CP diagnosis has been made. In this project we
 are addressing this problem by developing criteria for infants with high risk to develop CP
 based on early signs of atypical motor development and on perinatal risk factors. That means
 that we will include both infants who will get and infants who will not get the CP diagnosis.
 Children who are not meeting the criteria of CP at 2 years of age will be excluded from the
 analysis. The investigators assume that the intervention will influence the course of
 development and help the children to function at a higher level, but not that the
 intervention will "cure" CP and prevent later diagnosis. Infants with increased risk to
 develop CP will be recruited in this project.

 The study group will be recruited from infants exposed to increased perinatal risk factors,
 such as preterm birth, hypoxia, infections, retinopathy of prematurity (ROP) chronic lung
 disease and heart insufficiency, small for gestational age, hypoxic ischemic insult and
 morphological brain abnormalities. These children commonly participate in a clinical follow
 up programme at the children's hospital with regular examinations at 3months. The high-risk
 preterm infants that at follow up examinations exhibit a delayed psycho-motor development or
 display clinical signs of abnormal neurology will be recruited. Recruitment will also include
 children below 8 months, demonstrating delayed psycho-motor development or clinical signs of
 abnormal neurology referred to the physiotherapy department from child neurologists at the
 hospital.

 Randomisation The aim is to include 40 children in the study group with neurodevelopmental
 disorder to reach sufficient power in the study. This number is high but the investigators
 expect that about 50% will not fulfil the diagnose criteria at 2 years of age based on
 previous experience from intervention studies. The aim is to include 20 children with CP,
 which is a reasonable approximation of study population size to reach sufficient power. The
 children will be allocated to group by block randomisation. The intervention group (n=20)
 will take part in a newly developed Small-Step-Program. The comparison group (n=20) will
 continue their ordinary follow up programme. Stratification will be used to control for
 gestational age (preterm<37 and term>37 week). Children in the Small-Step-Program" will be
 further randomised to start with the mobility step or hand use step.

 Rational for second randomisation Our hypothesis is that the trained step will improve, while
 the non-trained step will result in minor changes and that children in the control group will
 have a continuous developmental pace. The randomised steps are hand use and mobility.

 The children in both groups will be assessed at four occasions, at start (first examination),
 after 12 weeks (second examination) and after 30 weeks (third examination) as well as at 2
 years of age (fourth examination). For children in the study group there will be 3 additional
 times for assessments in order to investigate the second hypothesis. Parents in both groups
 will be asked to fill in questionnaires' at all four examinations. Both parents will be asked
 to fill out the questionnaires.
Inclusion Criteria:

 will be based on delayed psychomotor development, as assessed by Alberta Motor Infants
 Scale, using -2SD as a cut-off point. Neurological signs will be investigated by
 Hammersmith Infant Neurological examination (HINE) together with a clinical neurological
 examinations. Magnetic resonance imaging (MR) will be used if available to support the risk
 of development of CP, only MR done for clinical purpose will be used. The risk factors
 suggested for inclusion in the intervention program will be confirmed by a child
 neurologist.

 Exclusion Criteria:

 is unstable health, uncontrolled epilepsy, progressive disorder, diagnosis with a specific
 syndrome. Parent's communication language should be Swedish or English with satisfactory
 skills in either language for simple conversation. If the children show a catch-up in
 development at the second assessment (after 12 weeks) and show no sign of
 neurodevelopmental disorder the program will be terminated