- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05137353
A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)
RitMoZ Training: A Randomized Control Trial Study to Assess a Multisensory Music Intervention for Children With Reading Disorders in Hungary
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Studies have shown that music in the form of training (i.e., intervention) is able to facilitate linguistic processes (e.g., phonological encoding/decoding, categorical perception) and cognitive functions (e.g., working memory) in children that have dyslexia or reading difficulties. In addition to this, music trainings with a focus on entrainment can improve phonological as well as reading skills.
In line with the above, we have designed and developed a music training programme. This programme, which is called RitMoZ Training (i.e., from Ritmus és Mozgás és Zene: meaning Rhythm and Movement and Music in Hungarian language), is designed for (Hungarian) children who have dyslexia or reading difficulties.
In order to assess the efficacy of the music training, we are going to conduct a randomized controlled trial which consists of a pre-training phase, a training phase and a post-training phase.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Budapest, Hungría, 1117
- Research Centre for Natural Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- diagnosis of reading disorder
- Hungarian as native language
Exclusion Criteria:
- comorbidities (e.g., Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD))
- sensory impairment (e.g., hearing loss, low vision)
- cognitive impairment (e.g., panic disorder, low IQ)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Music Training (RitMoZ Training)
12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions
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This training is inspired by intervention concepts followed in SUVAG Polyclinic in Zagreb, Croatia and Kodaly pedagogy in Hungary.
RitMoZ Training programme consists of 6 main activities: matching activity, nursery rhymes, rhythmic stimulations, music shapes, music writing and music reading.
The training focuses on the perceptual overlap between language and music, embodiment and entrainment.
The aim of the training is to improve characteristic features of reading disorders such as phonological awareness, perception of rhythm, phonological working memory and perception of speech sounds.
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Comparador activo: Spelling Training
12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions
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This training consists of activities which focus on practicing spelling words in a computer task; the aim is to train orthographic processing which is suggested to improve phonological awareness and phonological working memory.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Reading test
Periodo de tiempo: 4 minutes
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For the assessment of the ability to read aloud series of high frequency words, low frequency words and pseudowords, is applied from the shortened 3DM-H (Differential Diagnostics of Dyslexia Maastricht - Hungarian adaptation).
With this test, reading speed, fluency and accuracy and pseudoword accuracy are measured.
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4 minutes
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Spelling test
Periodo de tiempo: 4-7 minutes
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For the assessment of spelling, the present subtest is applied from the shortened version of the 3DM-H.
Both spelling accuracy and reaction time are measured.
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4-7 minutes
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Phoneme deletion test
Periodo de tiempo: 3-7 minutes
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For the assessment of phoneme deletion, the present subtest is applied from the shortened version of the 3DM-H.
Both accuracy and reaction time are measured.
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3-7 minutes
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Letter-sound identification test
Periodo de tiempo: 2-3 minutes
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For the assessment of letter-sound identification, the present subtest is applied from the shortened version of the 3DM-H.
Both accuracy and reaction time are measured.
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2-3 minutes
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Letter-sound discrimination test
Periodo de tiempo: 2 - 4 minutes
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For the assessment of letter-sound discrimination, the present subtest is applied from the shortened version of the 3DM-H.
Both accuracy and reaction time are measured.
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2 - 4 minutes
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Rapid Automatized Naming (RAN) test
Periodo de tiempo: 3-5 minutes
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To assess rapid naming of letters, digits and objects, the present subtest is applied from the shortened version of the 3DM-H.
Here, the processing speed is measured.
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3-5 minutes
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Choice reaction time test
Periodo de tiempo: 1 - 2 minutes
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The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
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1 - 2 minutes
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Lexical decision task
Periodo de tiempo: 12- 15 minutes
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To assess lexical decision, the present test is applied.
Here, accuracy is measured.
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12- 15 minutes
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Auditory discrimination of acoustic and phonetic alteration of pseudowords
Periodo de tiempo: 20 minutes
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This is an Event-Related Potentials (ERPs) task where a speech multifeature paradigm is applied.
In the current task, the amplitudes of the Mismatch Negativity (MMN) responses - which are elicited in certain time windows - are measured in every condition.
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20 minutes
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ferenc Honbolygó, PhD, Research Centre for Natural Sciences
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Neo-Prism-C ESR-10 project
- H2020-MSCA-ITN-2018 813546 (Otro número de subvención/financiamiento: MARIE SKŁODOWSKA-CURIE INNOVATIVE TRAINING NETWORK (ITN))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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