Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

Официальное название

Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach for Infants at Risk of Cerebral Palsy

Обзор

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.

Подробное описание

This study aimed to evaluate the feasibility, safety, caregiver acceptability, and satisfaction levels of the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention model based on the environmental enrichment (EN) paradigm and widely used in the literature, as a hybrid approach for infants at risk for cerebral palsy (CP). Furthermore, the effects of the intervention on the achievement of individualized functional goals, developmental outcomes, and parental well-being will be examined. Unlike previous studies, the HEP intervention in this study will be implemented as a hybrid model, implemented both in the clinic and at home. The intervention will be delivered in one-hour sessions per week for 12 weeks to 17 infants aged 4-10 months corrected age, identified as at risk for CP through either the Prechtl Assessment of General Movements or abnormal brain imaging confirmed by a pediatric neurologist. The feasibility, safety, and caregiver acceptance of the intervention will be assessed using a 24-item Likert-type scale developed by the researcher. Developmental outcomes will be measured by the Goal Attainment Scale (GAS), Bayley Developmental Scales for Infants and Toddlers-III (Bayley-III), Infant Sensory Function Test (ISFT), and Depression Anxiety Stress Scale-21 (DASS-21).

Вмешательства

• Другое The Homeostasis-Enrichment-Plasticity (HEP®) Approach
  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 formu

Первичные конечные точки

• Feasibility Questionnaire [Срок оценки: From July 2025 to November 2025]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 2 центра

• Sense On, Ltd. — Istanbul
• Sense On — Istanbul

Идентификаторы

NCT: NCT07116148 · E-10840098-202.3.02-4232

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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