- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Budapest, Hongarije, 1117
- Research Centre for Natural Sciences
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reading test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ferenc Honbolygó, PhD, Research Centre for Natural Sciences
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Neo-Prism-C ESR-10 project
- H2020-MSCA-ITN-2018 813546 (Ander subsidie-/financieringsnummer: MARIE SKŁODOWSKA-CURIE INNOVATIVE TRAINING NETWORK (ITN))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .