Effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) Approach Delivered Via Telerehabilitation in Preterm Infants at Risk for Developmental Delay: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Infant Motor Profile (IMP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 4 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Infant Motor Profile (IMP)
时间窗: 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)
时间窗: 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.
次要结局
- The Ages and Stages Questionnaires (ASQ)(At baseline and immediately after the 12-week intervention.)
- The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)(At baseline and immediately after the 12-week intervention.)
- Depression Anxiety Stress Scales-21 (DASS-21)(At baseline and immediately after the 12-week intervention.)
- Young Children's Participation and Environment Measure (YC-PEM)(At baseline and immediately after the 12-week intervention.)
- The Goal Attainment Scale (GAS)(At baseline and immediately after the 12-week intervention.)
研究者
Izgi Miray Demirbag
Physiotherapist and PhD Candidate
Medipol University