HEP® Delivered Via Telerehabilitation for Preterm Infants With Developmental Risks

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Medipol University trials in Turkey

Other trials for the same condition