Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

This study aimed to evaluate the feasibility, safety, and caregiver acceptance of the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention based on the environmental enrichment paradigm, applied as a hybrid model for infants at risk for cerebral palsy (CP). The effects on functional goals, development, and parental well-being will be examined. The intervention consists of weekly one-hour sessions for 12 weeks with 17 infants aged 4-10 months at risk for CP, identified via the Prechtl Assessment or brain imaging. Feasibility and acceptance will be assessed by a 24-item Likert scale. Developmental outcomes will be measured with GAS, Bayley-III, ISFT, and DASS-21.

NCT Number	NCT07116148
Lead Sponsor	Medipol University
Conditions	Cerebral Palsy (CP)
Enrollment	22 participants
Start Date	2025-09-05
Primary Completion	2025-11 (estimated)
Study Completion	2025-11 (estimated)
Updated on ClinicalTrials.gov	2025-11-14