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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
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.
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.
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Istanbul, Beykoz, Turkey (Türkiye)
RECRUITINGPeabody 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.
Time frame: Pre-intervention and 12-week post-intervention.
Test of Sensory Functions in Infants (TSFI)
Developed to assess sensory responsiveness, this test consists of five subsections and 24 items, and takes 20 minutes to administer. The test subsections include tactile deep pressure response, adaptive motor functions, visual-tactile integration, oculomotor control, and vestibular stimulus response. This test is suitable for evaluating at-risk groups for sensory processing disorders, such as infants with developmental delays. Based on their score, the infant is assessed as normal, at-risk, or impaired in terms of sensory processing. A higher score indicates better sensory processing.
Time frame: Pre-intervention and 12-week post-intervention.
The Ages and Stages Questionnaires (ASQ)
The ASQ is a developmental screening test that allows parents to assess a child's development. The questionnaires consist of three sections: demographic questions, a 30-question section about the child's development, and seven open-ended questions. The 30 questions addressing the child's development cover the areas of communication, fine motor development, gross motor development, problem-solving, and personal and social development, with each section consisting of six questions.
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Time frame: Pre-intervention and 12-week post-intervention.