Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach for Infants at Risk of Cerebral Palsy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aimed to evaluate the feasibility, safety, and caregiver acceptance of the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention based on the environmental enrichment paradigm, applied as a hybrid model for infants at risk for cerebral palsy (CP). The effects on functional goals, development, and parental well-being will be examined. The intervention consists of weekly one-hour sessions for 12 weeks with 17 infants aged 4-10 months at risk for CP, identified via the Prechtl Assessment or brain imaging. Feasibility and acceptance will be assessed by a 24-item Likert scale. Developmental outcomes will be measured with GAS, Bayley-III, ISFT, and DASS-21.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 10 months
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
Turkey
Sense On
RECRUITING
Istanbul
Sense On, Ltd.
RECRUITING
Istanbul
Contact Information
Primary
İzgi Miray Demirbag, Physiotherapist
izgimiray@hotmail.com
05516626550
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2025-11
Participants
Target number of participants: 22
Treatments
Other: Infants at risk of cerebral palsy
The HEP Approach utilizes key principles of enriched environment models and brain plasticity. The therapists and family collaborate during the intervention process to offer permanent, ongoing, personal ized environmental stimulation to promote the child's active exploration and participation. Acrucial component of the HEP Approach is enhancing parenting self-efficacy to create en riched environmental conditions in the home and on an ongoing basis across environments.
Related Therapeutic Areas
Sponsors
Leads: Medipol University

This content was sourced from clinicaltrials.gov