- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06947512
Personalização de caracteres visuais e text-to-fala (TTS) para apoiar o aprendizado em alunos com dificuldades de leitura
Eficácia da personalização de parâmetros visuais e texto em fala para melhorar a velocidade, precisão e compreensão dos alunos com distúrbios de aprendizagem
Previous research has shown the importance of font type, size and spacing to facilitate text reading in dyslexia. A special automatized procedure was designed to select the most favorable parameters for both text visualization and text-to-speech (TTS) conversion to be used by students with reading difficulties. The validation of its outcomes will be carried out through a systematic comparison of the use of the personalized versus standard fonts and voices in reading and writing tests.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Seleggo is a free compensatory tool for dyslexic students. It is an online platform where school textbooks are transcribed and visualized on the screen in portable format (PDF) versions, characterized by special attention to graphical features and readability, and can be listened to via TTS technology. Special functions such as karaoke modality, conceptual maps building software, summary creation, verbal and visual definition search and the possibility to record and retrieve one's own notes and sketches are also provided. Each student with Specific learning Disorder (SLD) has a personal library and can choose the parameters for text visualization to facilitate reading, modifying the display of the text, choosing font, size and spacing, as well as TTS parameters, such as speed and pitch.
The availability of many options for text visualization and TTS, however, can be advantageous only as far as the students are able to choose and use parameters that objectively facilitate their reading and comprehension. Since the analysis of the literature suggests that subjective choices may be misleading and that general recommendations may not fit the individual's needs, we decided to build an automatized, as objective as possible procedure to help the students find the combination of parameters that is most likely to facilitate them in reading and studying. This procedure, composed by an initial, gross-grained subjective procedure and followed by a thorough, systematic analysis of reading and comprehension performance, was named "Seleggo test" to match the compensatory tool it was meant to complement.
The present study aims to assess the actual advantage of personalized parameter selection through the "Seleggo Test" procedure in supporting reading compared to the use of standard parameters. The working hypothesis is that children with reading disorders would benefit from personalized text features and TTS.
The recruitment of participants will take place in schools. It is foreseen that 30 participants are recruited for each of the three groups: typically Developing children (TD), Developmental Dyslexia (DD) and Special Educational Needs (SEN) - with reading difficulties).
Additional children will be recruited form patients with DD at Scientific Institute (IRCCS) E. Medea, if necessary to reach the expected number. Children will attend the third grade of primary school to the third grade of middle school (7 to 15 years old).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Maria Luisa Lorusso, Ph.D
- Número de telefone: 031-877592
- E-mail: marialuisa.lorusso@lanostrafamiglia.it
Locais de estudo
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-
LC
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Bosisio Parini, LC, Itália, 23842
- Recrutamento
- IRCCS E. Medea, polo di Bosisio Parini
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Contato:
- Maria Luisa Lorusso, Ph.D
- Número de telefone: 031-877592
- E-mail: marialuisa.lorusso@lanostrafamiglia.it
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Contato:
- Francesca Borasio, Ph.D
- E-mail: francesca.borasio@lanostrafamiglia.it
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TV
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Conegliano, TV, Itália, 31015
- Recrutamento
- IRCCS E.Medea, polo di Conegliano
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Contato:
- Federica Martinez, MD
- E-mail: federica.martinez@lanostrafamiglia.it
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Treviso, TV, Itália, 31100
- Recrutamento
- Associazione La Nostra Famiglia
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Contato:
- Malida Franzoi, MD
- E-mail: malida.franzoi@lanostrafamiglia.it
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria (for TD group):
- age 7-15 years
- no history of reading difficulties
- attends school in Italy
Exclusion Criteria (for TD group):
- special educational needs or diagnosis of neurodevelopmental disorders
Inclusion Criteria (for DD group):
- age 7-15 years
- diagnosis of Developmental Dyslexia or Specific Reading Disorder
- Attends school in Italy
Exclusion Criteria (for DD group):
- diagnosis of Intellectual Disability
Inclusion Criteria (for SEN group):
- age 7-15 years
- reported by school to have significant difficulties in reading and writing
- Attends school in Italy (at least 6 months continued schooling and exposure to the Italian language)
Exclusion Criteria (for SEN group):
- diagnosis of Intellectual Disability
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Participant
All participants in the study will be assessed with the Seleggo Test procedure and then tested on reading and writing to dictation in the two conditions, with personalized and with standard visual and auditory parameters for text visualization and TTS |
Seleggo Test is a computerized procedure to identify the personalized visual and auditory parameters facilitating reading and writing for each participant. By applying these parameters to the visualization and to the TTS software during reading of school texts, the participants are expected to be facilitated in reading and understanding the text. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters
Prazo: Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between reading speed (seconds to read the text displayed by the software) with personalized and with standard visual parameters |
Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
|
Reading facilitation (accuracy), i.e. the advantage in reading performance (accuracy) produced by personalized parameters as compared to standard parameters
Prazo: Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between reading accuracy (number of errors in reading the text displayed by the software) with personalized and with standard visual parameters |
Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
|
Comprehension facilitation, i.e. the advantage in auditory comprehension performance produced by personalized TTS parameters as compared to standard parameters
Prazo: Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between writing accuracy (number of errors in writing a pre-defined list of nonwords) for stimuli dictated with personalized and with standard auditory parameters in the TTS device |
Intervention will take place at day 1 assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
possibility to discriminate TD students' reading speed from that of students with DD and SEN
Prazo: about 10 months
|
difference (ANOVAs) in performance (in terms of speed, expressed in seconds per syllable) on the reading tests delivered by the software, between the three groups (TD, DD and SEN) |
about 10 months
|
|
possibility to discriminate TD students's reading accuracy from that of students with DD and SEN
Prazo: about 10 months
|
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the reading tests delivered by the software, between the three groups (TD, DD and SEN) |
about 10 months
|
|
possibility to discriminate TD students' writing accuracy from that of students with DD and SEN
Prazo: about 10 months
|
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the writing tests delivered by the software, between the three groups (TD, DD and SEN) |
about 10 months
|
|
validity and reliability values for the reading speed measures collected by the software
Prazo: about 10 months
|
Pearson's correlations between the speed measures collected during the test and the speed measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders). |
about 10 months
|
|
validity and reliability values for the reading accuracy measures collected by the software
Prazo: about 10 months
|
Pearson's correlations between the reading accuracy measures collected during the test and the accuracy measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders). |
about 10 months
|
|
validity and reliability values for the writing accuracy measures collected by the software
Prazo: about 10 months
|
Pearson's correlations between the writing accuracy measures collected during the test and the accuracy measures obtained on standardized writing tests (Assessment Battery for Developmental Reading and Spelling Disorders). |
about 10 months
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Lorusso ML, Borasio F, Panetto P, Curioni M, Brotto G, Pons G, Carsetti A, Molteni M. Validation of a Web App Enabling Children with Dyslexia to Identify Personalized Visual and Auditory Parameters Facilitating Online Text Reading. Multimodal Technologies and Interaction. 2024; 8(1):5.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Transtorno Específico de Aprendizagem
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Manifestações Neurocomportamentais
- Distúrbios do Neurodesenvolvimento
- Distúrbios da Comunicação
- Distúrbios de Linguagem
- Dificuldades de aprendizagem
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dislexia
Outros números de identificação do estudo
- 996
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Anonymous data will be shared through the Zenodo platform
Prazo de Compartilhamento de IPD
From the publication of the results onwards
Critérios de acesso de compartilhamento IPD
free access, for anonymous data only
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