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A Randomized Controlled Trial of Hybrid Environmental Enrichment-Based Early Intervention in Infants at Risk of Cerebral Palsy
Sponsor: Medipol University
Summary
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.
Official title: An Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach in Infants at Risk of Cerebral Palsy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
4 Months - 10 Months
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-02-01
Completion Date
2026-08-01
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
HEP-Based Early Intervention
HEP-Based Early Intervention The Homeostasis-Environmental Enrichment-Plasticity (HEP®) Approach is an ecological and holistic early intervention model based on the environmental enrichment paradigm. The intervention is designed to support infants at developmental risk by promoting physiological homeostasis, encouraging active environmental exploration, and facilitating neuroplasticity through enriched and meaningful experiences. In this study, the HEP approach will be implemented as a hybrid model combining clinic-based and home-based sessions. Intervention content will be individualized according to the infant's developmental needs and functional goals.
Conventional Early Intervention
Conventional early intervention will be delivered based on standard therapy practices commonly used in early intervention programs. The intervention will include a range of techniques aimed at improving muscle strength and supporting postural control. Therapeutic handling techniques will be applied by the therapist to prevent maladaptive movement patterns and to facilitate appropriate and functional movement responses. The intervention will be provided once weekly in one-hour sessions for 12 weeks.
Locations (2)
Sense On, Ltd.
Istanbul, Beykoz, Turkey (Türkiye)
Sense On
Istanbul, Beykoz, Turkey (Türkiye)