- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Budapest, Hongrie, 1117
- Research Centre for Natural Sciences
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
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.
|
|
Comparateur actif: 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
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reading test
Délai: 4 minutes
|
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.
|
4 minutes
|
|
Spelling test
Délai: 4-7 minutes
|
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.
|
4-7 minutes
|
|
Phoneme deletion test
Délai: 3-7 minutes
|
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.
|
3-7 minutes
|
|
Letter-sound identification test
Délai: 2-3 minutes
|
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.
|
2-3 minutes
|
|
Letter-sound discrimination test
Délai: 2 - 4 minutes
|
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.
|
2 - 4 minutes
|
|
Rapid Automatized Naming (RAN) test
Délai: 3-5 minutes
|
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.
|
3-5 minutes
|
|
Choice reaction time test
Délai: 1 - 2 minutes
|
The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
|
1 - 2 minutes
|
|
Lexical decision task
Délai: 12- 15 minutes
|
To assess lexical decision, the present test is applied.
Here, accuracy is measured.
|
12- 15 minutes
|
|
Auditory discrimination of acoustic and phonetic alteration of pseudowords
Délai: 20 minutes
|
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.
|
20 minutes
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ferenc Honbolygó, PhD, Research Centre for Natural Sciences
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Neo-Prism-C ESR-10 project
- H2020-MSCA-ITN-2018 813546 (Autre subvention/numéro de financement: MARIE SKŁODOWSKA-CURIE INNOVATIVE TRAINING NETWORK (ITN))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .