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

Not Applicable

• Conditions: Speech Therapy; Dyslexia; Children, Only

• Registration Number: NCT05383937
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Study Start: 2022-07
• Primary Completion: 2023-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reading fluency to the Alouette test.	Six month.	Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.

Secondary Outcome Measures

Name	Time	Method
Visual pattern.	Six month.	Difference in the number of errors to five visual pattern from the BALE and the EVALEO, in the intensive and the conventional arm.
Phonological processing tests.	Six month.	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.
Rehabilitation adhesion.	6 month	Number of speech therapy session performed by patient in each arms.
Speech langage rehabilitation cost.	6 month.	Differential cost/progress relation of intensive and classical rehabilitation.
Life Quality.	6 month.	Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.
Family and school evaluation.	6 month.	Difference to Visual Analog Scale (VAS) regarding the benefit of speech therapy rehabilitation, assessed by the family and the school teachers, in each arms.

Trial Locations

Locations (1)

CHU de besançon; 🇫🇷 Besançon, France