Status:
RECRUITING
The Effect of the HEP Approach in Infants With Down Syndrome
Lead Sponsor:
Izgi Miray Demirbag
Conditions:
Down Syndrome (DS)
Eligibility:
All Genders
4-12 years
Phase:
NA
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 tr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07163780
Start Date
September 3 2025
End Date
December 3 2025
Last Update
November 14 2025
Active Locations (1)
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1
Sense On
Istanbul, Beykoz, Turkey (Türkiye), 34810