The Effect of the HEP Approach in Infants With Down Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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,
• Поведенческое 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.

Первичные конечные точки

• Peabody Developmental Motor Scales-2 (PDMS-2) [Срок оценки: Pre-intervention and 12-week post-intervention.]

Вторичные конечные точки (2)

• Test of Sensory Functions in Infants (TSFI) [Срок оценки: Pre-intervention and 12-week post-intervention.]
• The Ages and Stages Questionnaires (ASQ) [Срок оценки: Pre-intervention and 12-week post-intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Sense On — Istanbul

Идентификаторы

NCT: NCT07163780 · E-10840098-202.3.02-2211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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