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SAFE Early Intervention for At-Risk Infants (SAFE-EFFECT)

2026年5月13日 更新者：Ecem Yildiz CANGUR、Gazi University

Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants

This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group.

Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities.

Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills.

Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This randomized controlled study investigates the effects of two different early intervention approaches in high-risk infants. The SAFE intervention program is compared with conventional Neurodevelopmental Treatment (NDT). Assessments include upper extremity function, fine motor development, and developmental outcomes measured at baseline and follow-up periods. The study aims to determine which intervention provides superior improvement in early motor and developmental skills.

研究类型

介入性

注册 (估计的)

34

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Ankara
      • Ankara、Ankara、土耳其（türkiye）、06490
        • 招聘中
        • Gazi University Faculty of Health Sciences
        • 接触：
        • 首席研究员：
          • Ecem Yıldız Çangur, PT, MSc

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent

Exclusion Criteria:

  • Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：SAFE EARLY İNTERVENTION group
SAFE-based early intervention for high-risk infants: The SAFE early intervention approach will be implemented to improve proximal stabilisation in high-risk infants aged between 3 and 12 months.
行为的：SAFE Early Intervention Program
Structured early intervention program designed for high-risk infants focusing on upper extremity function, fine motor development, and neurodevelopmental outcomes during 8 weeks, 5 days/week
有源比较器：NDT TREATMENT GROUP
Neurodevelopmental Treatment (NDT): The NDT approach, which aims to develop fine motor skills in high-risk infants aged between 3 and 12 months, will be implemented
行为的：NDT TREATMENT
Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hand Assessment for Infants (HAI)
大体时间：Baseline and after 8 weeks of intervention
he Hand Assessment for Infants (HAI) will be used to evaluate upper extremity and hand function in high-risk infants through observational video analysis. The assessment includes reaching, grasping, object manipulation, bilateral hand use, and spontaneous hand movements during structured play activities.
Baseline and after 8 weeks of intervention
Peabody Developmental Motor Scales - Second Edition (PDMS-2)
大体时间：Baseline and after 8 weeks of intervention
The Peabody Developmental Motor Scales - Second Edition (PDMS-2) will be used to assess gross and fine motor development in high-risk infants aged 3-12 months. The assessment includes reflexes, stationary skills, locomotion, object manipulation, grasping, and visual-motor integration. Higher scores indicate better motor performance and developmental function.
Baseline and after 8 weeks of intervention

次要结果测量

结果测量
措施说明
大体时间
Canadian Occupational Performance Measure (COPM)
大体时间：Baseline and after 8 weeks of intervention
The Canadian Occupational Performance Measure (COPM) will be used to evaluate parent-perceived performance and satisfaction related to the infant's functional goals. Parents will identify important activity-related goals and rate performance and satisfaction using a 10-point scale. Higher scores indicate better occupational performance and greater parental satisfaction.
Baseline and after 8 weeks of intervention
PedsQL™ Infant Quality of Life Scale (1-12 Months)
大体时间：Baseline and after 8 weeks of intervention
The PedsQL™ Infant Quality of Life Scale will be used to assess health-related quality of life in infants based on parent report. The scale evaluates physical functioning, emotional status, social interaction, and general well-being. Higher scores indicate better quality of life.
Baseline and after 8 weeks of intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gazi University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月16日

初级完成 (估计的)

2026年6月16日

研究完成 (估计的)

2026年7月16日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026 - 86
  • thesis (Gazi University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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