NCT07163780 The Effect of the HEP Approach in Infants With Down Syndrome
| NCT ID | NCT07163780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Izgi Miray Demirbag |
| Condition | Down Syndrome (DS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2025-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2025-09-03 with a primary completion date of 2025-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Aymen Balıkcı, Dr. Physiotherapist
STUDY DIRECTOR
Frequently Asked Questions
Who can join the NCT07163780 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 12 Months, studying Down Syndrome (DS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07163780 currently recruiting?
Yes, NCT07163780 is actively recruiting participants. Contact the research team at izgimiray@hotmail.com for enrollment information.
Where is the NCT07163780 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07163780 clinical trial?
NCT07163780 is sponsored by Izgi Miray Demirbag. The principal investigator is Aymen Balıkcı, Dr. Physiotherapist. The trial plans to enroll 26 participants.