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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkia (Türkiye), 34810
- Istanbul Medipol University, Kavacık Campus
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
|
Aktiv komparator: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Infant Motor Profile (IMP)
Tidsramme: 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)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Ages and Stages Questionnaires (ASQ)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Aymen Balıkcı, Dr. Physiotherapist, Aymen Balıkcı
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-10840098-202.3.02-2212
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .