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临床试验/NCT07091474
NCT07091474
尚未招募
不适用

Little Movers: Promoting Motor Development in Early Childhood Through Educational and Therapeutic Interventions

University of Castilla-La Mancha0 个研究点目标入组 80 人开始时间: 2025年9月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
University of Castilla-La Mancha
入组人数
80
主要终点
Change in caregiver and educator knowledge and attitudes about motor development, as assessed with a 5-point Likert-scale questionnaire

概览

简要总结

The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays.

The primary prevention component includes structured educational workshops designed for three age groups: 0-12 months, 13-24 months, and 25-36 months. These workshops focus on typical motor milestones, the importance of active play, early stimulation strategies, and how to recognize early warning signs of motor development delays. Participation impact will be measured using pre- and post-workshop surveys and semi-structured interviews with parents, caregivers, and educators.

The secondary and tertiary prevention component consists of a longitudinal observational study that follows infants aged 0 to 12 months. Motor development will be assessed using validated tools, including the Standardized Infant Hand Assessment (s-HAI), the Hammersmith Infant Neurological Examination (HINE), the Infant Motor Profile (IMP), and the Ages and Stages Questionnaire (ASQ-3). Infants with typical development will be reassessed annually, while those at risk or showing signs of motor delay will be monitored monthly. The goal is to detect motor delays as early as possible to allow timely referral and intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Children with diagnosed neurological or genetic conditions affecting motor development. Families or educators who decline participation or do not provide informed consent. Children or families not enrolled in the participating daycare center.

结局指标

主要结局

Change in caregiver and educator knowledge and attitudes about motor development, as assessed with a 5-point Likert-scale questionnaire

时间窗: Immediately before and immediately after each workshop session (same day)

Knowledge and attitudes toward early motor development will be evaluated using a structured questionnaire administered immediately before and after workshop sessions. The questionnaire includes 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Total scores are calculated as the average of all items. Higher scores represent greater knowledge and more positive attitudes toward the importance of early motor milestones and play-based stimulation.

Neurological function in infants assessed by the Hammersmith Infant Neurological Examination (HINE)

时间窗: Monthly assessments from 2 to 24 months of age.

The Hammersmith Infant Neurological Examination (HINE) is a standardized clinical tool used to evaluate neurological function in infants aged 2 to 24 months. It includes domains such as cranial nerve function, posture, tone, and reflexes. The global score ranges from 0 to 78 points; higher scores indicate more typical neurological development. Scores below 40 in high-risk infants are associated with an increased probability of developing cerebral palsy.

Motor behavior in infants assessed by the Infant Motor Profile (IMP)

时间窗: Monthly assessments from 3 to 18 months of age

The Infant Motor Profile (IMP) is a standardized clinical assessment that evaluates the quality and variability of motor behavior in infants aged 3 to 18 months. The IMP provides scores across several domains (variation, adaptability, symmetry, fluency, and performance), with total scores calculated as a percentage (0-100%). Higher scores indicate more optimal and typical motor development. The assessment is designed to be repeated over time to monitor change in motor patterns, with results summarized as mean or change in percentage scores per assessment period.

次要结局

  • Unimanual hand function assessed by the Standardized Infant Hand Assessment (s-HAI)(Monthly from 3 to 12 months of age)
  • Developmental progress assessed by Ages and Stages Questionnaire, Third Edition (ASQ-3)(Monthly from birth to 12 months of age)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

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