Clinical Research Directory

A Randomized Controlled Trial of Hybrid Environmental Enrichment-Based Early Intervention in Infants at Risk of Cerebral Palsy

This randomized controlled trial aims to evaluate the effects of a hybrid environmental enrichment-based early intervention grounded in the Homeostasis-Enrichment-Plasticity (HEP®) Approach in infants at risk of cerebral palsy (CP). Infants aged 4-10 months identified as being at risk for CP through the Prechtl Assessment or brain imaging will be randomly assigned to either a HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period. Outcomes related to functional goal attainment, developmental performance, and parental well-being will be assessed using the Goal Attainment Scaling (GAS), Bayley Scales of Infant and Toddler Development-III (Bayley-III), Test of Sensory Functions in Infants (TSFI), and Depression Anxiety Stress Scales-21 (DASS-21). Feasibility, safety, and caregiver acceptance of the intervention will also be examined.