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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Istanbul
-
Istanbul, Istanbul, Turquía (Türkiye), 34810
- Istanbul Medipol University, Kavacık Campus
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
Otros nombres:
|
|
Comparador activo: Usual Care
Participants receive usual care during the 12-week study period.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Infant Motor Profile (IMP)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
|
The Alberta Infant Motor Scale (AIMS)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Ages and Stages Questionnaires (ASQ)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
|
The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
|
Depression Anxiety Stress Scales-21 (DASS-21)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
|
Young Children's Participation and Environment Measure (YC-PEM)
Periodo de tiempo: 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.
|
At baseline and immediately after the 12-week intervention.
|
|
The Goal Attainment Scale (GAS)
Periodo de tiempo: 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."
|
At baseline and immediately after the 12-week intervention.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Aymen Balıkcı, Dr. Physiotherapist, Aymen Balıkcı
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E-10840098-202.3.02-2212
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .