Actively Recruiting

Phase Not Applicable
Age: 4Months - 10Months
All Genders
NCT07116148

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

Age: 4Months - 10Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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