Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07163780
NA

The Effect of the HEP Approach in Infants With Down Syndrome

Sponsor: Izgi Miray Demirbag

View on ClinicalTrials.gov

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.

Official title: The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome

Key Details

Gender

All

Age Range

4 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-09-03

Completion Date

2025-12-03

Last Updated

2025-11-14

Healthy Volunteers

No

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.

Locations (1)

Sense On

Istanbul, Beykoz, Turkey (Türkiye)