Home-based early intervention in infants at high risk for cerebral palsy: a protocol of a randomised controlled trial study with CareToy

Introduction Care Toy (CT), a new technological system equipped with sensorized toys has been developed as a tele‐rehabilitation tool for home early intervention, recently tested in infants born preterm with promising results. This study aims to design a randomised controlled trial to evaluate the effectiveness of home‐based early intervention with Care Toy in infants at high‐risk for cerebral palsy (CP). Patients and method Infants born at term or preterm were recruited when showing: (1) specific or doubtful neurological signs at neurological examination and when using Prechtl's General Movement Assessment and (2) neuroimaging evidence of early brain lesion. After enrolment, the home‐based intervention will start when the infant reaches a minimum level of gross‐motor competences (i.e. initial head control). Recruited infants will be randomised in two groups: Care Toy intervention and infant massage. Infants allocated in the Care Toy group will receive the Care Toy system at home and will perform a highly customized goal‐directed intervention remotely monitored by rehabilitation staff. Infants allocated in the infant massage group will receive an infant massage parents’ course at home. Both early interventions will last 8 weeks. All enrolled infants will be evaluated with standardised scales and questionnaires at baseline (T0), at the end of the early intervention period (T1), 8 weeks after T1 (T2), and at 18 months of after term age (T3). Infant Motor Profile will be the primary outcome measure. Results The randomised controlled trial study started in September 2017, and enrolment is ongoing. The trial has been registered at www.clinicaltrials.gov (Identifier NCT03234959). Conclusion This work describes the randomised controlled trial methodology to evaluate the effectiveness of home‐based early interventions by Care Toy.