NCT07116148 Hybrid Early Intervention for Infants at Risk of Cerebral Palsy
| NCT ID | NCT07116148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medipol University |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2025-09-05 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Infants who meet the following criteria will be included in the study: * According to the general movement assessment, babies from birth to the 8th week have poor repertoire, synchronized cramps or chaotic movement pattern, and the presence of abnormal fidgeting movements between the 6th and 9th weeks. * A neurologist has detected the presence of abnormal brain imaging on magnetic resonance imaging or cranial ultrasound, * Absence of congenital anomalies, * The family agrees to participate regularly in the study. Exclusion Criteria: * Major vision or hearing problems, * Presence of any genetic syndrome or congenital anomaly, * Medical conditions that prevent active participation in the study (such as oxygen dependence), * Participation in other experimental rehabilitation studies
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07116148 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 10 Months, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116148 currently recruiting?
Yes, NCT07116148 is actively recruiting participants. Contact the research team at izgimiray@hotmail.com for enrollment information.
Where is the NCT07116148 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07116148 clinical trial?
NCT07116148 is sponsored by Medipol University. The trial plans to enroll 22 participants.
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