Clinical trial Recruiting at 1 site Interventional Ages 4 Months to 12 Months

HEP therapy for motor and sensory development in infants with Down syndrome

Official title: The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome

Run by Medipol University · NCT07163780 · Data updated 2026-11-12

This study tests whether the HEP (Homeostasis‑Enrichment‑Plasticity) therapy helps motor and sensory development in babies aged 4–12 months with Down syndrome.

Quick facts

Study typeInterventional
Ages4 Months to 12 Months
SexAll
Enrollment26 (estimated)
SponsorMedipol University
Academic / other
Locations1 site (Istanbul, Beykoz)
StatusRecruiting
StartedSeptember 3, 2025
Main results expectedDecember 3, 2025
Study endsDecember 3, 2025
Registry record updatedNovember 14, 2025
Trial IDNCT07163780 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants aged 4 to 12 months with a confirmed diagnosis of Down syndrome, no major neurological risk factors, and with parents willing to attend weekly sessions and complete study assessments.

Probably not a fit

Infants with major vision or hearing loss, a history of high‑grade intraventricular hemorrhage, active medical conditions that prevent participation (e.g., oxygen dependence), recent febrile seizures, or those already in other experimental rehabilitation programs are unlikely to benefit from or be eligible for this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single‑site interventional study in Istanbul will enroll infants with Down syndrome and compare the HEP approach to traditional pediatric rehabilitation over 12 weekly 45‑minute sessions. Parents will provide informed consent and demographic and perinatal data will be collected. Outcomes include gross and fine motor skills (PDMS‑2), infant sensory function (BDFT), parent‑reported development (ASQ), individualized goals (GAS), and social validity by parent questionnaire. Participants will be recruited via social media and professional referrals to a private clinic in Beykoz.

Why it matters

Potential benefit: If successful, HEP could help infants with Down syndrome reach motor and sensory milestones earlier and improve early developmental progress.

How similar studies have gone: Early enrichment and targeted early‑intervention programs for infants with developmental risk have shown promise in improving motor and sensory outcomes, but the specific HEP approach is relatively novel and has limited prior published data.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Sense On
    Istanbul, Beykoz, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.