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Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

NCT07116148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-11-14

No results posted yet for this study

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)

Interventions

OTHER

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

Sponsors & Collaborators

  • Medipol University

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116148 on ClinicalTrials.gov