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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslexia; Children, Only; Speech Therapy
• Intervention / Treatment: Other: Speech Therapy INTENS-DYS

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofiane ZIAMNI; Phone Number: +33381218988; Email: sziamni@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intensive arm; The children included in this arm will receive two weeks of daily care during which two daily speech therapy sessions of one hour each will be performed. This will be done between M2 and M4 of inclusion in order to avoid potential measurement bias. These sessions will be carried out by a state-qualified speech therapist employed at the CRRF of Bregille. They will guide the intensive rehabilitation of dyslexic children by focusing the exercises on their main difficulties.	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.
Active Comparator: classic arm or gold standard; The speech therapy session will be provided only by private practitioners, with a weekly consultation of 30 minutes. The private speech therapist who initially referred the patient for inclusion in the research protocol will be responsible for his or her "classic" rehabilitation. The therapy will continue during the 6 months of research.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Life Quality.	Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.	6 month.
Rehabilitation adhesion.	Number of speech therapy session performed by patient in each arms.	6 month
Speech langage rehabilitation cost.	Differential cost/progress relation of intensive and classical rehabilitation.	6 month.
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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Julien BEVALOT, CHU de Besancon

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Children; Dyslexia; Speech Therapy; Intensive rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Learning Disabilities; Dyslexia; Communication Disorders
• Other Study ID Numbers: 2022/692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No