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 type | Interventional |
|---|---|
| Ages | 4 Months to 12 Months |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Medipol University Academic / other |
| Locations | 1 site (Istanbul, Beykoz) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | December 3, 2025 |
| Study ends | December 3, 2025 |
| Registry record updated | November 14, 2025 |
| Trial ID | NCT07163780 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
- Study coordinator: İzgi Miray Demirbağ, Physiotherapist
- Email: izgimiray@hotmail.com
- Phone: +905516626550
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Levetiracetam to prevent seizures in adults with Down syndrome and Alzheimer's disease
This trial will test whether the anti-seizure medicine levetiracetam can prevent tonic-clonic seizures and slow cognitive decline in adults over 40 who have Down syndrome and symptomatic Alzheimer's disease.
-
Therapy plan for children with Down syndrome and acute myeloid leukemia in Russia
This trial will test a standardized four-course chemotherapy program for children (0–18) with AML and Down syndrome in Russia to try to improve survival and reduce treatment side effects.
-
Epi-ON corneal crosslinking with UVA for people with Down syndrome and corneal ectasia
This trial will try Epi-ON corneal crosslinking (riboflavin drops plus UVA light) to see if it can slow or stop corneal thinning and vision loss in people with Down syndrome who have keratoconus or similar ectatic corneal conditions.
-
Technology to promote healthy lifestyles in young people with intellectual disabilities
This project will try a smartphone-based program with families and teachers to help children and young adults with intellectual disabilities move more and eat healthier.
-
Assessing Inspire therapy for adolescents with Down syndrome and severe sleep apnea
This study is testing a new sleep therapy for teenagers with Down syndrome and severe sleep apnea to see if it helps them sleep better and improves their quality of life.
-
Effects of Suspension Therapy on Mobility and Balance in Children with Down Syndrome
This study is testing if Suspension Therapy can help improve balance and mobility in young children with Down syndrome.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.