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

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 4 Months to 12 Months
• Sex: All
• Sponsor: Medipol University (other)
• Locations: 1 site (Istanbul, Beykoz)
• Trial ID: NCT07163780 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Istanbul, Beykoz

• Sense On — Istanbul, Beykoz, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: İzgi Miray Demirbağ, Physiotherapist

Conditions: Down Syndrome, Infants, Early Intervention, Neuroplasticity, Environmental Enrichment