Developmental Delays, Prematurity
Conditions
Keywords
HEP, Homeostasis-Enrichment-Plasticity, Telerehabilitation, Early Intervention, Preterm Infant, Developmental Risk, Environmental Enrichment, Neuroplasticity, Pediatric Rehabilitation, Randomized Controlled Trial
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.
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.
Interventions
BEHAVIORALHomeostasis-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.
BEHAVIORALUsual 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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Months to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Infant Motor Profile (IMP) | At baseline and immediately after the 12-week intervention. | 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. |
| The Alberta Infant Motor Scale (AIMS) | At baseline and immediately after the 12-week intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ages and Stages Questionnaires (ASQ) | At baseline and immediately after the 12-week intervention. | 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. |
| The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE) | At baseline and immediately after the 12-week intervention. | 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. |
| Depression Anxiety Stress Scales-21 (DASS-21) | At baseline and immediately after the 12-week intervention. | 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. |
| Young Children's Participation and Environment Measure (YC-PEM) | At baseline and immediately after the 12-week intervention. | 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. |
| The Goal Attainment Scale (GAS) | At baseline and immediately after the 12-week intervention. | 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." |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAymen Balıkcı, Dr. Physiotherapist
Aymen Balıkcı
Outcome results
None listed