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.