Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.

Children, Only Clinical Trial

— INTENS-DYS  

Official title:

Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05383937
• Other study ID #: 2022/692
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: July 2024

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Sofiane ZIAMNI
• Phone: +33381218988
• Email: sziamni[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dyslexia is characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. However, no clinical trial of a standardized rehabilitation has shown an impact on reading fluency. In the era of intensive rehabilitation, a new protocol based on the current data from the medical literature has been designed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children from 8 to 12 years old,
• Living in and around 50 kilometers from Besançon.
• Diagnosis of dyslexia according to the DSM-V or CIM-10 requirements.
• Consent form signed by the parental authority and the child,
• Affiliation to a social security system.

Exclusion Criteria:

• Mother's medical history of pregnancy or delivery complications,
• Patients's medical history of neurological infectious, vascular or tumoral events,
• Patient's medical history of intellectual deficiency,
• Patients's medical history of visual or hearing disorders,
• Patient's medical history of psychiatric disorders (especially diagnosis of Attention Deficit / Hyperactivity Disorders (AD/HD)),
• legal incapacity,
• limited cooperation suspected by the investigator.

Related Conditions & MeSH terms

• Children, Only
• Communication Disorders
• Dyslexia
• Speech Therapy

Intervention

Other:
• Speech Therapy INTENS-DYS
During the six research month, children included in the intensive arm will benefit of two daily hours speech therapy during two weeks. Those one will be carried out between the second and the fourth month.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading fluency to the Alouette test.	Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.	Six month.
Secondary	Phonological processing tests.	Difference in the number of errors in logatom repetition, which means phonological rules of a language corresponding of meaningless words, in the intensive and the conventional arm.	Six month.
Secondary	Visual pattern.	Difference in the number of errors to five visual pattern from the BALE and the EVALEO, in the intensive and the conventional arm.	Six month.
Secondary	Life Quality.	Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.	6 month.
Secondary	Rehabilitation adhesion.	Number of speech therapy session performed by patient in each arms.	6 month
Secondary	Speech langage rehabilitation cost.	Differential cost/progress relation of intensive and classical rehabilitation.	6 month.
Secondary	Family and school evaluation.	Difference to Visual Analog Scale (VAS) regarding the benefit of speech therapy rehabilitation, assessed by the family and the school teachers, in each arms.	6 month.