CareToy Early Intervention in Infants at Risk for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood
      disabilities with high cost for individuals and society. Early Intervention (EI), if
      intensive enough but affordable by patients, family and health services can improve its
      outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in
      gross and fine motor skills, visual development and parent infants interaction in preterm
      infants. Recently, a new technological tool, called CareToy has been developed as a
      tele-rehabilitation tool for delivering at home EI. The effects of CT training on
      neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants
      with very promising results. The aim of the project is to provide evidence, by a RCT, of the
      efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12
      months (or with motor competencies from initial head control to unstable sitting position) at
      high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants
      will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group
      will perform a training with CT while the others will perform infant massage. Both trainings
      will be carried out at home by parents with the monitoring of the therapists. Both
      interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9
      wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant
      Motor Profile will be the primary outcome measure.
    

Detailed description: 
      The eligibility of infants, i.e. infants who meet the criteria for inclusion and exclusion
      (i.e infants at high-risk for CP) will be evaluated by the Neonatology team and the
      recruitment will be done after discharge from Neonatal Intensive Care Unit (NICU) during the
      follow up performed by infants previously enrolled in the first observational phase (aimed to
      identify infants at high risk for CP) and will begin with the signing of the participation
      agreement by the parents. The study is designed as randomized clinical trial. Recruited
      infants will be randomized in two groups: CareToy intervention vs Infant Massage. All infants
      will perform the home based and family centered early intervention according to their
      allocation group for 8 weeks. Before (T0), after the intervention period (T1) and in follow
      up (at T2, 8 wks after T1 and at 18 mths of post term age) all infants will be evaluated with
      standardized scales and questionnaires in order to evaluate the effects of EI on motor,
      cognitive and visual development and parent-infant interaction. Moreover the sleep
      organization, before and after the intervention, will be studied using actigraphs. The sample
      size has been calculated on the basis of the primary outcome measure (Infant Motor Profile).
    

Intervention name(s): CareToy intervention; Infant Massage
Intervention type(s): Device; Other
Intervention description(s): Infants will perform goal directed activities inside the CareToy System; Infants will received IM by their parents
Other intervention name(s): CT; IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Intervention; Cerebral Palsy; CareToy Intervention; Infant Massage; Information Communication Technology