The Effect of the HEP Approach in Infants With Down Syndrome

NCT07163780 | Recruiting

• 1 other identifier: E-10840098-202.3.02-2211
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Down Syndrome; Infants; Early Intervention; Neuroplasticity; Environmental Enrichment

Outcome Measures

Primary Outcomes (1)

• Peabody Developmental Motor Scales-2 (PDMS-2)

  The PDMS-2 is a scale used to identify motor developmental delays in children aged 0-6 and to determine motor skill levels and individual needs. The PDMS-2 consists of two main sections: gross motor and fine motor, and 249 items. The gross motor section consists of reflexes, balance, locomotion, and object manipulation, while the fine motor section consists of comprehension and visual-motor integration. A score of 2 is given if the child's performance is within the desired level, 1 if it is similar to the desired level, and 0 if it is not. To determine the risk and level of developmental delay, gross motor skills, fine motor skills, and general motor development are categorized as "very low, low, below average, average, above average, high, and very high," using age-appropriate normative ranges in the test manual.

  Pre-intervention and 12-week post-intervention.

Secondary Outcomes (2)

• Test of Sensory Functions in Infants (TSFI)

  Pre-intervention and 12-week post-intervention.

• The Ages and Stages Questionnaires (ASQ)

  Pre-intervention and 12-week post-intervention.

Other Outcomes (1)

• The Goal Attainment Scale (GAS)

  Pre-intervention and 12-week post-intervention.

Study Arms (2)

HEP Intervention

EXPERIMENTAL

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

Behavioral: HEP Intervention

Traditional Therapy

ACTIVE COMPARATOR

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

Behavioral: Traditional Therapy

Interventions

HEP Intervention 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.

HEP Intervention

Traditional Therapy 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.

Traditional Therapy

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izgi Miray Demirbag: lead

Study Sites (1)

Sense On

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Aymen Balıkcı, Dr. Physiotherapist

  STUDY DIRECTOR

Central Study Contacts

İzgi Miray Demirbağ, Physiotherapist

CONTACT

+905516626550; izgimiray@hotmail.com

Gamze Cagla Sırma, Physiotherapist

CONTACT

+905454470067; cagladirgen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

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

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 3, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)