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

NCT07727733 | Completed

• 1 other identifier: E-10840098-202.3.02-7368
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Preterm Infants at Developmental Risk

Keywords

Premature; Environmental enrichment; Early intervention; Tele-rehabilitation

Outcome Measures

Primary Outcomes (1)

• The Infant Motor Profile (IMP)

  The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months CA. The IMP is based on a video recording of a semi-standardized play session of about 15 minutes, during which an assessor plays with the infant in such a way that the IMP items can be assessed. This means that the playing assessor has knowledge of the IMP items, allowing her to adapt the assessment to the infant's functional abilities and the IMP needs. The 80 items of the IMP evaluate motor behaviour in supine and prone positions; while sitting, standing, and walking; when reaching and grasping; and during manipulation. It is a discriminative, evaluative, and predictive measurement. The IMP has been developed for health care professionals working in the feld of early detection of developmental disorders and early intervention.

  At baseline and immediately after the 12-week intervention

Secondary Outcomes (2)

• The Alberta Infant Motor Scale (AIMS)

  At baseline and immediately after the 12-week intervention

• The Ages and Stages Questionnaires (ASQ)

  At baseline and immediately after the 12-week intervention

Study Arms (1)

HEP® Tele-Rehabilitation Intervention

EXPERIMENTAL

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

Interventions

Intervention OTHER

The HEP® (Homeostasis-Environmental Enrichment-Plasticity) Approach is a child-centered, family-based early intervention program grounded in the principles of homeostasis, environmental enrichment, and neuroplasticity. This approach is based on by ecological and developmental theories, including Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model.

HEP® Tele-Rehabilitation Intervention

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Sense On , Istanbul, Beykoz 34810

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Methods

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study employed the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention method based on environmental enrichment and delivered through tele-rehabilitation. The HEP® approach is an ecological model designed to provide multidimensional support to infants at developmental risk during the early stages of development. It is grounded in a holistic integration of the biological foundations of development and environmental interactions. The intervention is structured around a theoretical framework that promotes physiological homeostasis, encourages exploration of the environment, and facilitates neuroplasticity. The HEP® approach aims to optimize the developmental potential of infants at risk for developmental difficulties through early, targeted environmental enrichment.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: July 27, 2026
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)