HEP® Delivered Via Telerehabilitation for Preterm Infants With Developmental Risks (HEP-Preterm)

Effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) Approach Delivered Via Telerehabilitation in Preterm Infants at Risk for Developmental Delay: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prematurity; Developmental Delays
• Intervention / Treatment: Behavioral: Homeostasis-Enrichment-Plasticity (HEP®) Approach; Behavioral: Usual Care Group

Detailed Description

Preterm infants are at increased risk for developmental delays due to biological immaturity and environmental factors that may adversely affect neurodevelopment during early life. Early intervention programs that actively involve families and provide enriched developmental experiences are recommended to optimize developmental outcomes during this critical period.

The Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention model that integrates principles of homeostasis, environmental enrichment, and neuroplasticity to support infant development through individualized, embedded in daily routines. Delivering this intervention via telerehabilitation may improve accessibility, promote caregiver engagement, and facilitate continuous professional support regardless of geographical barriers.

This randomized controlled trial aims to evaluate the effectiveness of the HEP® approach delivered via telerehabilitation in preterm infants at risk for developmental delay. Participants will be randomly assigned to either the HEP® telerehabilitation intervention or a control group receiving usual care. The intervention will be provided over a 12-week period through weekly online sessions and individualized home-based activities supported by parent coaching. Developmental, sensory, and family-related outcomes will be assessed to determine the effectiveness and feasibility of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34810
      • Istanbul Medipol University, Kavacık Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEP® Telerehabilitation; 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; 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.; Other Names: HEP® Approach; HEP® Early Intervention Approach
Active Comparator: Usual Care; Participants receive usual care during the 12-week study period.	Behavioral: Usual Care Group; 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.; Other Names: Standart Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ages and Stages Questionnaires (ASQ)	The ASQ is a developmental screening tool that enables parents to assess an infant's developmental progress. The questionnaire comprises three sections: demographic information, a 30-item developmental section, and seven open-ended questions. The 30-item section evaluates five developmental domains-communication, fine motor skills, gross motor skills, problem-solving, and personal-social development-each domain consisting of six questions.	At baseline and immediately after the 12-week intervention.
The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)	The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE) was developed as a complementary tool to the ASQ to assess social-emotional development and behavioral concerns in infants. The parent-completed questionnaire evaluates key domains, including self-regulation, adaptability, communication, adaptive behavior, autonomy, and emotional functioning.	At baseline and immediately after the 12-week intervention.
Depression Anxiety Stress Scales-21 (DASS-21)	The DASS-21 is a validated and reliable tool for screening depressive and anxiety disorders, and it effectively assesses the severity of three psychological states through 21 items. The scale consists of three subscales: depression (7 items), anxiety (7 items), and stress (7 items). Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Lower scores on the subscales indicate better psychological well-being.	At baseline and immediately after the 12-week intervention.
Young Children's Participation and Environment Measure (YC-PEM)	The YC-PEM is a parent-completed measure designed to assess the level and quality of participation of children aged 0-5 years in various activities and the environments in which these activities take place.	At baseline and immediately after the 12-week intervention.
The Goal Attainment Scale (GAS)	The Goal Attainment Scale (GAS) is the most commonly recommended goal-setting methodology for measuring change during and after intervention in clinical and research applications. The GAS, which assesses the child's achievement of individual goals established with parents at the beginning of the intervention, is a reliable tool for children with developmental challenges and provides subjective information about the child's needs. The GAS has a rating scale of "-2" to "+2."	At baseline and immediately after the 12-week intervention.

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Aymen Balıkcı, Dr. Physiotherapist, Aymen Balıkcı

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Neuroplasticity; Randomized Controlled Trial; Telerehabilitation; Early Intervention; Preterm Infant; HEP; Developmental Risk; Pediatric Rehabilitation; Environmental Enrichment; Homeostasis-Enrichment-Plasticity
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: E-10840098-202.3.02-2212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect participant confidentiality and privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No