- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952354
Oral Language in Children With Down Syndrome
August 4, 2009 updated by: University of Sao Paulo
Oral Language in Children With Down Syndrome: Lexical, Syntactic and Semantic Aspects
The objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU.
The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their production, when compared to children with typical development.
Study Overview
Status
Unknown
Conditions
Detailed Description
One of the alternatives to observe and assess language development and language disorders is to analyze spontaneous language samples, which allos the identification of qualitative and quantitative aspects.
The analysis involves the MLU-morphemes, MLU-words and words classes.
All words produced are analyzed, including interjections, adverbs and adjectives.Word classes with grammatical characteristics present lower averages, as prepositions and conjunctions.
Reference parameters are the ones of the spoken language.
The objective assessment with qualitative and quantitative data may help the speech and language pathologist/therapist to determine therapeutic guidelines to each patient.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 05360-160
- University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
60 children with Down syndrome aged from 3 to 10 years
Description
Inclusion Criteria:
- genetic diagnosis of Down syndrome
- good health conditions
- normal results on audiologic evaluation
- pediatric and ear, nose and throat periodic check ups.
- attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.
Exclusion Criteria:
- submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
- presence of visual or auditory important deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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research group
60 children aged from 3 to 10 years, both genders, observed in a symbolic play situation with their language therapists
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Suelly CO Limongi, PhD, University of Sao Paulo
- Principal Investigator: Rosangela V Andrade, PhD, University of Sao Paulo
- Principal Investigator: Fabiola C Flabiano, PhD student, University of Sao Paulo
- Principal Investigator: Porto Eliza, Ms student, University of Sao Paulo
- Principal Investigator: Angela MA Carvalho, Ms student, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Limongi SC, Oliveira Ede F, Ienne LM, Andrade RV, Carvalho AM. The use of nouns and verbs by children with Down syndrome in two different situations. Codas. 2013;25(3):262-7. doi: 10.1590/s2317-17822013000300012. English, Portuguese.
- Marques SF, Limongi SC. [Mean length utterance (MLU) as a measure of language development of children with Down syndrome]. J Soc Bras Fonoaudiol. 2011;23(2):152-7. doi: 10.1590/s2179-64912011000200012. Portuguese.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Anticipated)
August 1, 2009
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
August 6, 2009
Last Update Submitted That Met QC Criteria
August 4, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 473492/2007-5
- CNPq-473492/2007-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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