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

NCT07727720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-07-27

No results posted yet for this study

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

  • Preterm

Interventions

BEHAVIORAL

HEP® Tele-Rehabilitation Intervention

This group receives the HEP® Tele-Rehabilitation Intervention, an early intervention program based on the Homeostasis-Environmental Enrichment-Plasticity approach and delivered entirely through tele-rehabilitation. The intervention consists of 45-minute online sessions conducted weekly over 12 weeks and follows environmental enrichment principles. Parent training is provided to support the implementation of activities in the home environment, and individualized developmental goals are established for each infant at the beginning of the intervention. All assessments and intervention procedures are conducted remotely via online platforms.

Sponsors & Collaborators

  • Izgi Miray Demirbag

    lead OTHER

Principal Investigators

  • Aymen Balıkcı, Dr. Physiotherapist

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727720 on ClinicalTrials.gov