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The Effect of the HEP Approach in Infants With Down Syndrome

NCT07163780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-11-14

No results posted yet for this study

Summary

This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.

Conditions

  • Down Syndrome (DS)

Interventions

BEHAVIORAL

HEP Intervention

This intervention is administered to the HEP Intervention arm. The HEP approach, which includes intervention, is a child-centered, family-based early intervention approach based on the principles of enriched environment and plasticity, emphasizing the importance of homeostasis. It is based on theories that argue that development occurs as a result of the dynamic interaction between the environment, time, task, and individual (Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model). Hypotheses for intervention are generated based on a comprehensive assessment of these four fundamental factors (environment, time, task, and individual), and 10 core principles derived from environmental enrichment studies are applied with the guidance of ecological models.

BEHAVIORAL

Traditional Therapy

Participants in this arm will receive conventional pediatric therapy, consisting of 12 weekly sessions of 45 minutes each. Sessions will focus on standard motor and sensory development exercises, delivered by a physical therapist experienced in pediatric rehabilitation.

Sponsors & Collaborators

  • Izgi Miray Demirbag

    lead OTHER

Principal Investigators

  • Aymen Balıkcı, Dr. Physiotherapist

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2025-12-03
Completion
2025-12-03

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 NCT07163780 on ClinicalTrials.gov