Assessment of Hypotonia in Children With Down Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of a Measuring Instrument for the Evaluation of Hypotonia in Children With Down Syndrome

Conditions
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Muscle Hypotonia, Down Syndrome, Muscle, Floppy, CHILD Syndrome, Infant Floppy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old Exclusion Criteria: Other hypotonic syndromes

Ages Eligible for Study
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Minimum Age: 7 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Down Syndrome<br>Children with down syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program. | 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. | 1 month | 
| Analysis of the reliability of the scale | Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed | 1 month | 
| Content validity | 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. | 1 month | 
| Empirical validity. | 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. | 1 month | 
| Structural validity | Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program. | In the process of analysis. 1 month to get results. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of the scale | Analyzing the values of standard deviation, mean, bias and kurtosis. | 1 month | 
| Frequency analysis of the items. | Frequency with which 0 (less hypotonia), 1 or 2 (greater hypotonia) each item of the scale has been scored. | 1 month | 
| Analysis of the scale items. | An analysis of standard deviation, mean, correlation and Cronbach's alpha was performed for each item that made up the scale. | 1 month |