Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

Medipol University

Status: Enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Other: The Homeostasis-Enrichment-Plasticity (HEP®) Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07116148

E-10840098-202.3.02-4232

Details and patient eligibility

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.

Full description

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).

Enrollment: 22 estimated patients

Sex: All

Ages: 4 to 10 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Infants at risk of cerebral palsy

Other group

Description:

The HEP Approach utilizes key principles of enriched environment models and brain plasticity. The therapists and family collaborate during the intervention process to offer permanent, ongoing, personal ized environmental stimulation to promote the child's active exploration and participation. Acrucial component of the HEP Approach is enhancing parenting self-efficacy to create en riched environmental conditions in the home and on an ongoing basis across environments.

Treatment:

Other: The Homeostasis-Enrichment-Plasticity (HEP®) Approach