- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00947778
Analysis of Language and Auditory Abilities in Cochlear Implanted Children
Analysis of Language and Auditory Abilities in Cochlear Implanted Children: Assessment by an Auditory Learning Programmed Method
The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. These results are usually due to the children own factors (social, educational and handicap ones), one which any action has a limited effect.
Besides, there are external factors on which one can rely : " treatments ". For instance, an early cochlear implant on a child is the main stream to a better access to speak properly later. Another essential point to tackle is the early re-education training which remains essential to the treatment. Yet, there is a gap to fill between the theory and the main assistance in the auditory education practice.
The main objective of this survey is to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children aged from 4 to 10.
This study will be divided into two phases separated by 3 sessions of evaluation tests.
The first session T1 will occur in the two groups (experimentation on G1 and control on G2), then the first training session will start in group G1.
The second session T2 will occur in the two groups, then the first training session will start in group G2.
The third session T3 will occur in the 2 groups at the end of the experiment.
By training the 4 perceptible operations with different auditory stimulations (speech, music, sounds and electro-acoustic sounds), we are looking for better performance in the trained skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination and speech).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. These results are usually due to the children own factors (social, educational and handicap ones), one which any action has a limited effect.
Besides, there are external factors on which one can rely : " treatments ". For instance, an early cochlear implant on a child is the main stream to a better access to speak properly later. Another essential point to tackle is the early re-education training which remains essential to the treatment. Yet, there is a gap to fill between the theory and the main assistance in the auditory education practice.
Researches on auditory cognitive sciences make the distinctions between different operation treatments ranged from the identification of sounds sources to the discrimination of specific acoustic parameters to the analysis of auditory scenes and the memorization of its sources. (Mc Adams and Bigand, 1994).Each operation implies a specific treatment.
Yet, these operations are not systematically followed by a re-education treatment among deaf children even if one is to know that it has a positive impact on the linguistic skills.
They can be trained by a large range of non linguistic stimuli as these specific stimuli belong to the fundamental auditory cognition, their development lead to benefits on the treatment of all the auditory stimuli. Music is part and parcel of the chosen stimuli, as many critics have proved that music was a source of transfer effect for visual and spatial skills for instance (Giomi-Costa, 2003) A synthesis of these researches has been at the source of the so called " method of programmed auditory skills " whose purpose was to develop the complete auditory skills abilities. This complete teaching programme has been integrated in a playful context for children that allows to control the action, the gesture and the game as well as the sounds atmosphere. This teaching programme is controlled by a computer with a large number of different sounds and which is linked to the playful sphere.
The main objective of this survey is to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children aged from 4 to 10.
This study will take place in the CHU de La Timone in Marseilles in the ENT children department and is at the heart of a cooperation with Dr Emmanuel Bigand team in Dijon (LEAD CNRS, UMR 5022 à Dijon). The cochlear implant children department in Marseilles gathers a group of more than 70 implanted children aged from 4 to 10 that is in adequacy with the parameters for the method to evaluate.
Two groups of 21 cochlear implant children will be included in this study.
This study will be divided into two phases separated by 3 sessions of evaluation tests.
The first session T1 will occur in the two groups (experimentation on G1 and control on G2), then the first training session will start in group G1.
The second session T2 will occur in the two groups, then the first training session will start in group G2.
The third session T3 will occur in the 2 groups at the end of the experiment.
By training the 4 perceptible operations with different auditory stimulations (speech, music, sounds and electro-acoustic sounds), we are looking for better performance in the trained skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination and speech).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Marseille, França
- Assistance Publique-Hôpitaux de Marseille
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- children with congenital deaf to speak
- children with cochlear implant Nucleus
Exclusion Criteria:
- children unable to understand orders in the oral or in the language of signs
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: session of training 1
Arm from which members will perform their training session after the first session of evaluation
|
3 sessions of evaluation tests, each session during 15 days
20 sessions of 30 minutes by week during 24 semaines
|
|
Comparador Ativo: Session of training 2
Arm from which members will perform their training session after the second session of evaluation
|
3 sessions of evaluation tests, each session during 15 days
20 sessions of 30 minutes by week during 24 semaines
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children.
Prazo: 18 months
|
18 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
to evaluate the efficiency of this auditory teaching programme (MPAA) over the transfer of learning towards tasks of perception and production of the word
Prazo: 18 months
|
18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephane Roman, Assistance Publique Hopitaux de Marseille
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimado)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2009-05
- 2009-A00343-54
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