- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Budapest, Hungary, 1117
- Research Centre for Natural Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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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Active Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reading test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ferenc Honbolygó, PhD, Research Centre for Natural Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neo-Prism-C ESR-10 project
- H2020-MSCA-ITN-2018 813546 (Other Grant/Funding Number: MARIE SKŁODOWSKA-CURIE INNOVATIVE TRAINING NETWORK (ITN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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