Actively Recruiting
Hybrid Early Intervention for Infants at Risk of Cerebral Palsy
Led by Medipol University · Updated on 2025-11-14
22
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hybrid Early Intervention for Infants at Risk of Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants from birth to 8 weeks with poor repertoire, synchronized cramps, chaotic movement pattern, or abnormal fidgeting movements between 6 and 9 weeks based on general movement assessment
- Abnormal brain imaging detected by a neurologist on MRI or cranial ultrasound
- No congenital anomalies
- Family agrees to participate regularly in the study
You will not qualify if you...
- Major vision or hearing problems
- Presence of any genetic syndrome or congenital anomaly
- Medical conditions that prevent active participation (e.g., oxygen dependence)
- Participation in other experimental rehabilitation studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sense On, Ltd.
Istanbul, Beykoz, Turkey (Türkiye), 34810
Actively Recruiting
2
Sense On
Istanbul, Beykoz, Turkey (Türkiye), 34810
Actively Recruiting
Research Team
İ
İzgi Miray Demirbag, Physiotherapist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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