The Effect of the HEP Approach in Infants With Down Syndrome
ConditionDown Syndrome (DS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorIzgi Miray Demirbag
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HEP Intervention
BehavioralThis 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
BehavioralParticipants 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.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: HEP InterventionExperimental treatment 1 intervention
Group B: Traditional TherapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Pre-intervention and 12-week post-intervention.Secondary outcomes
1
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.2
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.
Time frame
Pre-intervention and 12-week post-intervention.Other outcomes
1
The Goal Attainment Scale (GAS)
The Goal Attainment Scale (GAS) is the most commonly recommended goal-setting methodology for measuring change during and after intervention in clinical and research applications. The GAS, which assesses the child's achievement of individual goals established with parents at the beginning of the intervention, is a reliable tool for children with developmental challenges and provides subjective information about the child's needs. The GAS has a rating scale of "-2" to "+2."
Time frame
Pre-intervention and 12-week post-intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Izgi Miray Demirbag
Lead sponsor
Medipol University
Sponsor institution
Source ClinicalTrials.gov