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Completed

NCT Number: NCT05131542

Assessment of Hypotonia in Children With Down Syndrome

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.

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Key information

Conditions

Muscle Hypotonia Abnormalities, Multiple CHILD Syndrome Chromosome Disorders Congenital Abnormalities Congenital Hemidysplasia with Ichthyosiform Erythroderma and Limb Defects Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Infant Floppy Intellectual Disability Muscle, Floppy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Murcia

Murcia, 30100, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality assessment of items by homogeneity analysis. Statistical analysis was performed using the SPSS-21 program.

    Time frame: 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.

  2. Analysis of the reliability of the scale

    Time frame: 1 month

    Reliability was measured by Cronbach's alpha. An interclass and inter-judge correlation analysis was performed

  3. Content validity

    Time frame: 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.

  4. Empirical validity.

    Time frame: 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.

  5. Structural validity

    Time frame: In the process of analysis. 1 month to get results.

    Through an exploratory factor analysis. Factorial analysis was carried out using the FACTOR program.

Secondary outcomes

  1. Descriptive analysis of the scale

    Time frame: 1 month

    Analyzing the values of standard deviation, mean, bias and kurtosis.

  2. Frequency analysis of the items.

    Time frame: 1 month

    Frequency with which 0 (less hypotonia), 1 or 2 (greater hypotonia) each item of the scale has been scored.

  3. Analysis of the scale items.

    Time frame: 1 month

    An analysis of standard deviation, mean, correlation and Cronbach's alpha was performed for each item that made up the scale.

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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