Actively Recruiting
The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome
Led by Izgi Miray Demirbag · Updated on 2025-11-14
26
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of the Homeostasis-Enrichment-Plasticity (HEP) approach on motor and sensory development in infants with Down syndrome. This study aims to compare HEP therapy with traditional therapy in 26 infants diagnosed with Down syndrome, assessing developmental progress using standardized tests. The goal is to understand how these different therapies may influence infant development based on ecological theories and dynamic interaction models. Participants will be randomly assigned to receive either 12 weekly sessions of HEP therapy or 12 weekly sessions of traditional therapy, each lasting 45 minutes. The HEP approach is a child-centered, family-based early intervention that emphasizes enriched environments, plasticity, and homeostasis, while traditional therapy focuses on standard motor and sensory development exercises. Both therapies are delivered by experienced physiotherapists. Throughout the study, infants will undergo assessments before and after the 12-week intervention period using the Peabody Developmental Motor Scales-2 (PDMS-2), the Test of Sensory Functions in Infants (TSFI), and the Ages and Stages Questionnaires (ASQ) completed by parents. Individual goals will be set with the Goal Attainment Scale (GAS), and social validity will be evaluated through parent questionnaires. Data on demographics and perinatal history will also be collected. The total study duration includes the 12 therapy sessions and follow-up assessments.
CONDITIONS
Brief Title
The Effect of the HEP Approach in Infants With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- History of intraventricular hemorrhage (Grade III or IV)
- Major vision or hearing impairment
- History of febrile convulsion
- Medical conditions that prevent active participation in the study (e.g., oxygen dependence)
- Participation in other experimental rehabilitation studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive 12 weekly sessions of therapy, each lasting 45 minutes, either using the HEP approach or traditional therapy depending on their group assignment.
12 weekly visits (in-person)
Trial Site Locations
Total: 1 location
1
Sense On
Istanbul, Beykoz, Turkey (Türkiye), 34810
Actively Recruiting
Research Team
İ
İzgi Miray Demirbağ, Physiotherapist
G
Gamze Cagla Sırma, Physiotherapist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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