Hybrid Early Intervention for Infants at Risk of Cerebral Palsy
Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach for Infants at Risk of Cerebral Palsy
Medipol University
22 participants
Sep 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
The HEPApproach intervention and clinical reasoning process follow a systematic order based on the data-driven decision-making model. There are 11 phases to the HEP Approach process. Phase 1 involves referral to the program. Phase 2 includes a meeting with the family to introduce them to the HEP Approach. Phase 3 is a comprehensive assessment of the child and family systems. Phase 4 is the identification of family and child strengths and challenges based on the assessment. Phase 5 involves formulating hypotheses about how underlying factors or systems impact the child's challenge areas. Phases 6 and 7 include collaborative goal setting and outcome measure identification with the family. Phase 8 is intervention planning. Phase 9 implements the intervention through an individualized process that generally involves four steps that prioritize different areas of need (e.g., self-regulation and homeostasis of the child, adaptation of the physical and social home environment to support succes
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07116148