HEP® Delivered Via Telerehabilitation for Preterm Infants With Developmental Risks

NCT07725367 | Active Not Recruiting

• 1 other identifier: E-10840098-202.3.02-2212
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm infants are at increased risk for developmental delays, making early intervention essential for optimizing developmental outcomes. This study aims to evaluate the effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) approach delivered via telerehabilitation in preterm infants at risk for developmental delay. Eligible preterm infants will be randomly assigned to either the HEP® telerehabilitation group or the control group receiving usual care. The intervention will be delivered over 12 weeks through weekly online sessions combined with parent coaching and individualized home-based activities. The study will evaluate the effects of the intervention on infant development, sensory functions, goal attainment, and parental well-being. The findings may provide evidence for the use of family-centered telerehabilitation as an early intervention strategy for preterm infants at developmental risk.

Conditions

Prematurity; Developmental Delays

Keywords

HEP; Homeostasis-Enrichment-Plasticity; Telerehabilitation; Early Intervention; Preterm Infant; Developmental Risk; Environmental Enrichment; Neuroplasticity; Pediatric Rehabilitation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• The Infant Motor Profile (IMP)

  The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months corrected age (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.

• The Alberta Infant Motor Scale (AIMS)

  The Alberta Infant Motor Scale (AIMS) is a standardized assessment designed to evaluate motor development in infants. It specifically measures both fine and gross motor skills across a range of developmental stages. This assessment provides valuable information regarding infants' physical abilities and developmental progress. The test typically takes approximately 15 minutes to administer, and scores are interpreted by comparison with a normative database.

  At baseline and immediately after the 12-week intervention.

Secondary Outcomes (5)

• The Ages and Stages Questionnaires (ASQ)

  At baseline and immediately after the 12-week intervention.

• The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)

  At baseline and immediately after the 12-week intervention.

• Depression Anxiety Stress Scales-21 (DASS-21)

  At baseline and immediately after the 12-week intervention.

• Young Children's Participation and Environment Measure (YC-PEM)

  At baseline and immediately after the 12-week intervention.

• The Goal Attainment Scale (GAS)

  At baseline and immediately after the 12-week intervention.

Study Arms (2)

HEP® Telerehabilitation

EXPERIMENTAL

Participants receive the Homeostasis-Enrichment-Plasticity (HEP®) early intervention program delivered via telerehabilitation for 12 weeks through individualized parent coaching and home-based activities.

Behavioral: Homeostasis-Enrichment-Plasticity (HEP®) Approach

Usual Care

ACTIVE COMPARATOR

Participants receive usual care during the 12-week study period.

Behavioral: Usual Care Group

Interventions

Usual Care Group BEHAVIORAL

Participants receive standard pediatric rehabilitation care for 12 weeks. The intervention includes conventional developmental exercises and parent education based on the infant's developmental needs. Home exercises are recommended during weekly follow-up sessions according to routine clinical practice.

Also known as: Standart Care

Usual Care

Homeostasis-Enrichment-Plasticity (HEP®) Approach BEHAVIORAL

The Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention program delivered via telerehabilitation over 12 weeks. The intervention consists of weekly online sessions conducted by a pediatric physiotherapist and individualized home programs tailored to each infant's developmental needs. The HEP® approach integrates the principles of homeostasis, environmental enrichment, and neuroplasticity through parent coaching, individualized goal-directed activities, environmental adaptations, and embedding developmental opportunities into daily routines. Intervention content is continuously monitored and modified according to the infant's progress and family needs.

Also known as: HEP® Approach, HEP® Early Intervention Approach

HEP® Telerehabilitation

Eligibility Criteria

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

You may qualify if:

• Corrected age 4-12 months. Born at or before 36 weeks and 6 days of gestation. Parents willing to participate regularly and provide informed consent.

You may not qualify if:

• Major visual or hearing impairment. Genetic syndrome or congenital anomaly. Medical conditions preventing active participation (e.g., oxygen dependency). Participation in another experimental rehabilitation study during the study period.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University, Kavacık Campus

Istanbul, Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Aymen Balıkcı, Dr. Physiotherapist

  Aymen Balıkcı

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are randomly assigned to the intervention or control group and are not informed of their group allocation. Outcome assessments are conducted by an independent assessor who is blinded to group assignment. Due to the nature of the intervention, the care provider delivering the intervention is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist and PhD Candidate

Model Details: Participants will be randomly assigned to one of two parallel groups: an experimental group receiving the HEP® approach delivered via telerehabilitation or a control group receiving usual care. Participants will remain in their assigned group throughout the 12-week study period.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)