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Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome

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ClinicalTrials.gov Identifier: NCT00689988
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
University of Sao Paulo

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Children with Down syndrome (DS) have language development particularities that have negative effects in the communication capacity. By this way, Augmentative and Alternative Communication (AAC) is indicated to this population. The aim of this study was to verify the AAC impact in the lexical gain of children with DS.

Condition or disease Intervention/treatment Phase
Down Syndrome Behavioral: speech-language therapy with AAC intervention Not Applicable

Detailed Description:
Five children with DS, with the same cognitive level, participated in this study. Longitudinal follow-up of twelve months of speech-language therapy with AAC use was undertaken. A lexical evaluation was done at the beginning and the end of this follow-up. Correct responses in the lexical evaluation were increased, but not necessarily in the spoken modality. The comparisons showed significant results in use of substitutions processes, and to no-answers.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study
Study Start Date : July 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: SG
Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention
 Behavioral: speech-language therapy with AAC intervention
speech-language intervention in weekly 40-minutes sessions, without the presence of parents or caregivers, and 5 to 10-minutes to parents training and orientation


Outcome Measures
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Primary Outcome Measures :
  1. Performance on a initial and final lexical assessments, after 12 months of speech-language therapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • genetic diagnosis of Down syndrome
  • be at the preoperational period
  • good health conditions
  • expressive language impairment (communication by vocal and gestures, predominantly)

Exclusion Criteria:

  • presence of major malformations
  • presence of another genetic syndrome
  • severe neonatal asphyxia, hearing impairment or visual
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689988


Locations
Brazil
University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
São Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Sandra CF Pires, PhD student University of São Paulo
Study Chair: Suelly CO Limongi, PhD University of São Paulo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Suelly Cecilia Olivan Limongi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00689988     History of Changes
Other Study ID Numbers: 05/1149
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by University of Sao Paulo:
Down syndrome
communication AIDS for disabled
language development disorders
vocabulary
 gestures
language tests
child

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn