跳至主要内容
临床试验/NCT06180330
NCT06180330已完成不适用

The Impact of Water Activities on Motor Development in Infants

Józef Piłsudski University of Physical Education2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Change from Baseline in the Early Motor Development Questionnaire (EMQ) at 8 weeks

研究概览

简要总结

The study will be conducted at various city swimming pools in Warsaw. The study participants will include 20 infants participating in aquatic baby classes once a week and 20 infants not participating in any classes and their parents. The study will be conducted in a quiet and calm room, which will be prepared in advance and equipped with a smooth mat, a lounger and infant toys. The estimated time to conduct the study is about 30 minutes.

The examination will be carried out twice: before the start of the two-month course and after its completion. Each time in the presence of a parent or legal guardian, after signing a consent form for the study.

The selected methods of assessing motor development are fully non-invasive and consist of the following tests:

  1. Alberta Infant Motor Scale (AIMS)-a test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills.
  2. Early Motor Development Questionnaire (EMQ)-will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infants age 3-12 months

排除标准

  • any disability that would affect motor development

结局指标

主要结局

Change from Baseline in the Early Motor Development Questionnaire (EMQ) at 8 weeks

时间窗: Baseline and 8 weeks

The questionnaire will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development. EMQ incorporates parents' certainty in their answers by using a 5-point scale ranging from -2 (the parent is sure the child does not show the behavior yet) to +2 (the parent remembers a particular instance in which the child exhibited the behavior).

Change from Baseline in the Alberta Infant Motor Scale (AIMS) at 8 weeks

时间窗: Baseline and 8 weeks

The test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills. During the assessment, the evaluator observes the movements of the child and scores each movement component as either "observed" or "not observed".

次要结局

未报告次要终点

研究者

发起方
Józef Piłsudski University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

The Impact of Water Activities on Motor Development... | 临床试验