Small Step Intervention for Infants With Cerebral Palsy and Other Neurodevelopmental Disorders
Condition: Gross Motor Development Delay; Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Early intervention for infants; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three foci are included in the intervention: Communication, Hand function and Mobility/gross motor function. The Hand & Cognition and Mobility steps will be conducted during two time-periods. Communication will have a separate one-time intervention at the start of the study (prior to step I) in addition to one intervention period during step III (figure 1). General principles for the small step program: Training will be conducted in the children's home by the parents on a daily basis. The families will get instructions and supervision in their home every week by the therapist responsible for each specific step of the intervention. For each focus there will be different steps using an adaptive logarithm for training, i.e., adapted to the functional level of the child aiming at the next small developmental step. The family will be actively involved in identifying new foci for practice.; Children displaying delayed development and at risk of developing cerebral palsy are continuously followed-up at the children's hospital. There are no strict rules for the frequency of appointments within the usual care program but the families typically meet a physiotherapist every third week during the first 2-3 months, thereafter about once a month. The frequency depends on the family's needs and wishes. If there is a continuous need for therapeutic intervention and need of contact with different professions, the families will be referred to the Habilitation Services when the child is between 8-12 months. The control group will follow this customary procedure in the hospital. The only difference will be the assessment procedure, the sessions with the speech pathologist and that they will get feedback of the children's progress after each examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Children; Early Intervention; Communication; Gross motor function; Hand function