The Effect of the HEP Approach in Infants With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2025-12-03

Brief Summary

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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.

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Detailed Description

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This clinical study will be conducted at a private clinic in Istanbul and will enroll 26 infants with Down syndrome who meet the inclusion criteria. Participants will be recruited through social media and referrals from professionals who follow infants with Down syndrome.

Written informed consent will be obtained from parents after explaining the study's purpose, duration, assessments, and interventions. Demographic, perinatal, natal, and postnatal data will be collected via a "Demographic Information Form." Gross and fine motor skills will be evaluated with Peabody Developmental Motor Scales-2 (PDMS-2), sensory functions with the Infant Sensory Function Test (BDFT), and parents will complete the The Ages and Stages Questionnaires (ASQ) to assess multiple developmental domains. Individual goals will be set using the Goal Attainment Scale (GAS), and social validity will be assessed post-intervention via a parent questionnaire.

The intervention group will receive 12 sessions (once a week, 45 minutes each) of HEP therapy, delivered by a physiotherapist experienced in the HEP approach. The control group will receive 12 sessions of traditional therapy administered by an experienced pediatric rehabilitation physiotherapist.

Conditions

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Down Syndrome (DS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study includes two groups: one group will receive the HEP intervention, and the other group will receive traditional therapy.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HEP Intervention

Participants will receive 12 sessions of HEP therapy, once per week, 45 minutes each.

Group Type EXPERIMENTAL

HEP Intervention

Intervention Type BEHAVIORAL

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.

Traditional Therapy

Participants will receive 12 sessions of traditional therapy, once per week, 45 minutes each.

Group Type ACTIVE_COMPARATOR

Traditional Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must be between 4 and 12 months old
* Must have been diagnosed with Down Syndrome
* Must not be at any neurological risk
* Parent must agree to participate regularly in the study process

Exclusion Criteria

* History of intraventricular hemorrhage (Grade III or IV)
* Major vision or hearing impairment
* History of febrile convulsion
* Medical conditions (e.g., oxygen dependence) that prevent active participation in the study
* Participation in other experimental rehabilitation studies

Minimum Eligible Age

4 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No