Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
研究概览
简要总结
Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.
详细描述
Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old
排除标准
- •Other hypotonic syndromes
结局指标
主要结局
Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.
时间窗: 1 month
A study of homogeneity of the items was carried out to know if each item was measuring the same as the globality of the test. It was carried out by means of a reliability study of the statistics of each item compared to the total scale.
Analysis of the reliability of the scale
时间窗: 1 month
Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed
Content validity
时间窗: 1 month
It was done through expert judgment. It was reviewed by three physiotherapists with extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Empirical validity.
时间窗: 1 month
The correlation between the graduation of hypotonia derived from the scale and the observational diagnosis estimated by the evaluator was analyzed. An ANOVA test was used to compare both diagnostic assessments.extensive experience in treating hypotonic children and those items directed to the orofacial complex were also agreed with an expert speech therapist.
Structural validity
时间窗: In the process of analysis. 1 month to get results.
Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.
次要结局
- Descriptive analysis of the scale(1 month)
- Analysis of the scale items.(1 month)
- Frequency analysis of the items.(1 month)
研究者
María Guadalupe de Santos Moreno
Principal Investigator
Universidad de Murcia