Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

NCT07116148 | Recruiting

• 1 other identifier: E-10840098-202.3.02-4232
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy (CP)

Keywords

Environmental enrichment, early intervention, hybrid model, plasticity, cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Feasibility Questionnaire

  A 24-item Likert-type questionnaire was developed by the researcher to evaluate the feasibility, acceptability, satisfaction level, and safety of the intervention. The questionnaire items were grouped under four main categories: feasibility (items 1-7), acceptability (items 8-12), satisfaction (items 13-19), and safety (items 20-24). The five-point Likert-type scale included response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).

  From July 2025 to November 2025

Other Outcomes (4)

• Goal Attainment Scaling

  From July 2025 to November 2025

• Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)

  From July 2025 to November 2025

• Test of Sensory Functions in Infants

  From July 2025 to November 2025

Study Arms (1)

Infants at risk of cerebral palsy

OTHER

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.

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

Interventions

The Homeostasis-Enrichment-Plasticity (HEP®) Approach 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

Infants at risk of cerebral palsy

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (2)

Sense On, Ltd.

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

Sense On

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

İzgi Miray Demirbag, Physiotherapist

CONTACT

05516626550; izgimiray@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study utilized HEP (Homeostasis Environmental Enrichment Plasticity), an environmental enrichment-based early intervention approach implemented with a hybrid model. The HEP approach is an ecological model that aims to provide multidimensional support to infants at developmental risk during the early developmental period. This approach is based on a holistic synthesis of the biological basis of development and environmental interactions. The intervention is built on a theoretical framework that supports physiological homeostasis, encourages environmental exploration, and activates neuroplasticity. The HEP approach aims to optimize the developmental potential of infants at risk for developmental difficulties through early environmental enrichment.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 11, 2025
• Study Start: September 5, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-09

Locations

TU (2)