- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05996497
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years (RnDys)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Longitudinal cross-over study carried out on 4 experimental groups to compare the effect of two rhythmic auditory trainings (30 Hz and low frequencies) compared to the effect of a grapho-phonological correspondence training (GraphoGame).
The study begins with a recruitment and inclusion period after diagnosis of dyslexia. During this study, 4 assessments are performed and include behavioral measures in the care setting and electrophysiological measures in the research setting:
- at time T1 before any remediation,
- at T2 after the first training,
- at T3 at most 7 days after the 2nd training session,
- at T4 seven weeks after T3.
After the T1 assessment, participants were randomized into 4 different groups (training 1 then training 2):
Group 1 : Auditory Rhythmic at 30 Hz then GraphoGame Group 2 : GraphoGame then Rhythmic Auditory at 30 Hz Group 3 : Auditory Rhythmic at low frequencies then GraphoGame Group 4 : GraphoGame then Auditory Low Frequency Rhythmic The first training period (total duration 6 weeks) according to the assigned group begins and takes place at the speech therapist's office and at home.
After the T2 evaluation, the 2nd training period (total duration 6 weeks) according to the assigned group begins and takes place at the SLP's office as well as at home.
The post-training evaluations T3 and T4 take place, respectively, 1 week and 7 weeks after the last training.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie Bouton, PhD
- Email: sophie.bouton@pasteur.fr
Study Contact Backup
- Name: Anne-Lise Giraud, PhD
- Phone Number: +33176535054
- Email: anne-lise.giraud-mamessier@pasteur.fr
Study Locations
-
-
-
Paris, France
- Recruiting
- Institut de l'Audition
-
Contact:
- Diane Lazard, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between 7 and 9 years old
- in regular schooling
- have a diagnosis of dyslexia
- have a non-verbal intelligence assessment within the norm. Inclusion assessments must show a major reading disability without associated cognitive deficits.
- be equipped with a PC at home
- have given their assent and whose parents/legal guardians have given their oral consent
Exclusion Criteria:
- have any other diagnosis of language impairment
- have a neurological disorder (visual, auditory, executive)
- have an associated psychiatric disorder
- have a developmental delay.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Auditory Rhythmic at 30 Hz then GraphoGame
Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)
|
behavioral measures
Electrophysiological measures
Training 1
Training 2
|
|
Other: GraphoGame then Rhythmic Auditory at 30 Hz
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)
|
behavioral measures
Electrophysiological measures
Training 1
Training 2
|
|
Other: Auditory Rhythmic at low frequencies then GraphoGame
Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)
|
behavioral measures
Electrophysiological measures
Training 1
Training 2
|
|
Other: GraphoGame then Auditory Low Frequency Rhythmic
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)
|
behavioral measures
Electrophysiological measures
Training 1
Training 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Time Frame: 2 years
|
Comparison of reading performance is assessed in terms of both accuracy and speed.
High percentage of correct responses means that children improve their reading accuracy.
|
2 years
|
|
Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Time Frame: 2 years
|
Comparison of reading performance is assessed in terms of both accuracy and speed.
A short time means that children improve their reading speed.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
Time Frame: 2 years
|
Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
|
2 years
|
|
Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
Time Frame: 2 years
|
Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diane Lazard, MD, Institut Pasteur
- Study Director: Anne-Lise Giraud, PhD, Institut Pasteur
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-063
- 2022-A01132-41 (Other Identifier: ID RCB)
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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