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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00952354
Other study ID # 473492/2007-5
Secondary ID CNPq-473492/2007
Status Active, not recruiting
Phase Phase 2
First received August 3, 2009
Last updated August 4, 2009
Start date August 2007
Est. completion date August 2009

Study information

Verified date August 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date August 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 10 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

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