HEP Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study | NCT07727733

NCT07727733

Overview

NCT ID: NCT07727733
Lead Sponsor: Medipol UniversityOTHER
Official Title: Feasibility Study of HEP® (Homeostasis-Enrichment-Plasticity) Tele-Rehabilitation for Preterm Infants at Developmental Risk
Brief Summary: Several early intervention approaches based on sensory and motor environmental enrichment have demonstrated neurobehavioral benefits and improvements in motor and cognitive skills in infants. Tele-rehabilitation has also been shown to positively impact the motor and cognitive development of at-risk infants. However, limited research has examined the effects of environmental enrichment-based early interventions delivered via tele-rehabilitation on sensory, motor, cognitive, language, and socio-emotional skills, adaptive behaviors, parental goals, and parental anxiety in preterm infants at developmental risk, as well as the feasibility of delivering such interventions online. The proposed study aims to evaluate the effects of the environmental enrichment-based HEP® approach delivered through tele-rehabilitation on these developmental outcomes in preterm infants, thereby contributing to the existing literature.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 27, 2026Actual
Start Date: Oct 1, 2024Actual
Primary Completion Date: Apr 1, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Infants with a corrected age between 4 and 12 months.

Infants born at or before 36 weeks and 6 days of gestation.

Infants with no congenital anomalies.

Families who agree to participate regularly in the study process.

Exclusion Criteria:

Infants with major visual or hearing impairments.

Infants with any genetic syndrome or congenital anomalies.

Infants with medical conditions that prevent active participation in the study (e.g., oxygen dependence).

Infants participating in other experimental rehabilitation studies.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 16Actual
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Sense On , Istanbul, Beykoz 34810

Similar Studies

Participant Group/Arms

HEP® Tele-Rehabilitation InterventionExperimental

This arm includes infants receiving the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention program delivered entirely online through tele-rehabilitation. The intervention is conducted in 45-minute sessions over 12 weeks, following environmental enrichment principles. Parent training is provided to support the implementation of activities at home, and individualized developmental goals are established for each infant at the beginning of the intervention. All assessments and the intervention are conducted online.

Other: Intervention