Clinical Trials Directory

Trials / Completed

CompletedNCT05131542

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
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Universidad de Murcia · Academic / Other
Sex
All
Age
7 Months – 8 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-04-01
Primary completion
2021-12-31
Completion
2022-01-15
First posted
2021-11-23
Last updated
2022-01-21

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05131542. Inclusion in this directory is not an endorsement.