Symbolic Representation in Young Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:

The Constitution of Symbolic Representation in Young Children With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668980
• Other study ID #: 06/50842-4
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: January 13, 2010
• Start date: July 2006
• Est. completion date: April 2009

Study information

• Verified date: January 2010
• 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 aim of this study is to characterize the process of constitution of symbolic representation in infants with Down syndrome, as well as to investigate the relationship between gestures and the emergence of oral language. The investigators hypothesis is that children with Down syndrome could present difficulties during the constitution of symbolic representation that may be related to later deficits on expressive language, generally observed in these children.

Description:

According to the Genetic Epistemology, language development is directly related to cognitive construction. Such relationship is clearly observed after the constitution of representation that allows one individual to express his or her thinking through language.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria for Study Group:

• genetic diagnosis of Down Syndrome

• be at the 4th stage of sensorimotor period at the initial assessment

• good health conditions

• good results on audiologic evaluation

• pediatric and ear, nose and throat periodic check ups.

Inclusion Criteria for Control Group:

• good health conditions

• be at the 4th stage of sensorimotor period at the initial assessment

• pediatric and ear, nose and throat periodic check ups.

Exclusion Criteria for all groups:

• 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

• historic of prematurely and/or low birth weight

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
Brazil	APAE Sao José dos Campos	Sao Jose Dos Campos	Sao Paulo
Brazil	University Hospital	Sao Paulo	São Paulo
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	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on monthly assessments administered after the initial evaluation		12 months	No