Hybrid early therapy program for infants at risk of cerebral palsy
Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach for Infants at Risk of Cerebral Palsy
This trial will try a hybrid home-and-clinic HEP® therapy for infants 4–10 months old at risk for cerebral palsy to see if it is feasible, safe, and helpful for development and families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 4 Months to 10 Months |
| Sex | All |
| Sponsor | Medipol University Academic / other |
| Locations | 2 sites (Istanbul, Beykoz and 1 other locations) |
| Trial ID | NCT07116148 on ClinicalTrials.gov |
What this trial studies
The HEP® approach uses environmental enrichment principles to deliver targeted early intervention aimed at maximizing neuroplasticity in infants at risk for cerebral palsy. In a hybrid delivery model, therapists provide one-hour sessions once weekly for 12 weeks, combining clinic visits and home-based activities for a total of 17 infants aged 4–10 months corrected age. Infants are identified as at risk by the Prechtl General Movements assessment or by abnormal brain imaging confirmed by a pediatric neurologist. Feasibility, safety, and caregiver acceptance are measured with a 24-item Likert scale, while developmental outcomes use GAS, Bayley-III, ISFT, and parental well-being is tracked with the DASS-21.
Who should consider this trial
Good fit: Infants aged 4–10 months corrected age who are identified as at risk for cerebral palsy by the Prechtl General Movements assessment or abnormal brain imaging, without major sensory deficits or genetic syndromes, and whose families can attend weekly sessions are ideal candidates.
Not a fit: Infants with major vision or hearing impairments, genetic syndromes or congenital anomalies, medical conditions preventing active participation (such as oxygen dependence), or those enrolled in other experimental rehabilitation studies are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, the HEP hybrid program could improve early motor and developmental outcomes and reduce caregiver stress by providing targeted enrichment during a critical window of brain plasticity.
How similar studies have performed: Environmental enrichment approaches have shown promise in animal models and some early clinical work, but the specific HEP® hybrid delivery for infants at risk of CP is a novel application with limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Infants who meet the following criteria will be included in the study: * According to the general movement assessment, babies from birth to the 8th week have poor repertoire, synchronized cramps or chaotic movement pattern, and the presence of abnormal fidgeting movements between the 6th and 9th weeks. * A neurologist has detected the presence of abnormal brain imaging on magnetic resonance imaging or cranial ultrasound, * Absence of congenital anomalies, * The family agrees to participate regularly in the study. Exclusion Criteria: * Major vision or hearing problems, * Presence of any genetic syndrome or congenital anomaly, * Medical conditions that prevent active participation in the study (such as oxygen dependence), * Participation in other experimental rehabilitation studies
Where this trial is running
Istanbul, Beykoz and 1 other locations
- Sense On, Ltd. — Istanbul, Beykoz, Turkey (Türkiye) (Recruiting)
- Sense On — Istanbul, Beykoz, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: İzgi Miray Demirbag, Physiotherapist
- Email: izgimiray@hotmail.com
- Phone: 05516626550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.