Assessment of Hypotonia in Children With Down Syndrome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05131542

Enrollment

Registered

2021-11-23

Start date

2019-04-01

Completion date

2022-01-15

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

7 Months to 8 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results