Reading DisorderNCT05137353
A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)
A study testing Music Training (RitMoZ Training) and Spelling Training in people with Reading Disorder, run by Research Centre for Natural Sciences at 1 site in Hungary.
Trial summary
With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Disorder
- What is being tested?
- Music Training (RitMoZ Training) and Spelling Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteHungary
- Study dates
- 15 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of reading disorder
- Hungarian as native language
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RitMoZ Training: A Randomized Control Trial Study to Assess a Multisensory Music Intervention for Children With Reading Disorders in Hungary
With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.
Read the 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.
- Conditions
- Reading Disorder
- Being tested
- Music Training (RitMoZ Training), Spelling Training
- Keywords
- reading disorders, music intervention, rhythmic stimulations, phonological processing, Event-Related Brain Potentials
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Training (RitMoZ Training)Behavioural
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.
Spelling TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Training (RitMoZ Training) | Experimental | 12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions Receives: Behavioral: Music Training (RitMoZ Training) |
| Spelling Training | Active comparator | 12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions Receives: Behavioral: Spelling Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading test
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.
Measured: 4 minutes
Spelling test
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.
Measured: 4-7 minutes
Phoneme deletion test
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.
Measured: 3-7 minutes
Letter-sound identification test
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.
Measured: 2-3 minutes
Letter-sound discrimination test
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.
Measured: 2 - 4 minutes
Rapid Automatized Naming (RAN) test
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.
Measured: 3-5 minutes
Choice reaction time test
The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
Measured: 1 - 2 minutes
Lexical decision task
To assess lexical decision, the present test is applied. Here, accuracy is measured.
Measured: 12- 15 minutes
Auditory discrimination of acoustic and phonetic alteration of pseudowords
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Nov 2021
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Centre for Natural Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Ferenc Honbolygo, Research Centre for Natural Sciences
- Investigators
- Ferenc Honbolygó, PhD, Principal investigator, Research Centre for Natural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137353
- Sponsor's protocol ID
- Neo-Prism-C ESR-10 project
- Other IDs
- H2020-MSCA-ITN-2018 813546
- Status last verified
- Oct 2022
- First submitted
- 28 Nov 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RitMoZ Training: A Randomized Control Trial Study to Assess a Multisensory Music Intervention for Children With Reading Disorders in Hungary
- ClinicalTrials.gov ID
- NCT05137353
- Acronym / sponsor ID
- Neo-Prism-C ESR-10 project
- Conditions
- Reading Disorder
- Keywords
- reading disorders, music intervention, rhythmic stimulations, phonological processing, Event-Related Brain Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Research Centre for Natural SciencesUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Training (RitMoZ Training) | Experimental | Behavioral: 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 |
| Spelling Training | Active comparator | Behavioral: Spelling Training12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of reading disorder
- Hungarian as native language
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Training (RitMoZ Training)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. | Behavioural | Music Training (RitMoZ Training) |
| Spelling TrainingThis 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. | Behavioural | Spelling Training |
Primary outcome
Reading test
Time frame: 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.
Spelling test
Time frame: 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.
Phoneme deletion test
Time frame: 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.
Letter-sound identification test
Time frame: 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.
Letter-sound discrimination test
Time frame: 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.
Rapid Automatized Naming (RAN) test
Time frame: 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.
Choice reaction time test
Time frame: 1 - 2 minutes
The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
Lexical decision task
Time frame: 12- 15 minutes
To assess lexical decision, the present test is applied. Here, accuracy is measured.
Auditory discrimination of acoustic and phonetic alteration of pseudowords
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- This is the website which provides information and details about the intervention and the study procedure.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Reading Disorder
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferenc Honbolygó, PhD principal investigator
Research Centre for Natural Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Training (RitMoZ Training) and Spelling Training in people with Reading Disorder, run by Research Centre for Natural Sciences at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading test (time frame: 4 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.