Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

NCT ID: NCT07116148

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2025-11-30

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.

Detailed 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).

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Infants at risk of cerebral palsy

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.

Group Type: OTHER

The Homeostasis-Enrichment-Plasticity (HEP®) Approach

Intervention Type: OTHER

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

Interventions

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 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 10 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Izgi Miray Demirbag

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sense On, Ltd.

Istanbul, Beykoz, Turkey (Türkiye)

Site Status: RECRUITING

Sense On

Istanbul, Beykoz, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İzgi Miray Demirbag, Physiotherapist

Role: CONTACT

izgimiray@hotmail.com

05516626550

Facility Contacts

İzgi Miray Demirbağ, Physiotherapist

Role: primary

izgi.demirbag@std.medipol.edu.tr

05516626550

Gülay Aras Bayram, Assoc. Prof., PhD

Role: backup

garas@medipol.edu.tr

05054966284

Sense On Sense On, Ltd.

Role: primary

izgi.demirbag@std.medipol.edu.tr

05516626550

Other Identifiers

E-10840098-202.3.02-4232

Identifier Type: -

Identifier Source: org_study_id