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

NCT ID: NCT05383937

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-04-15

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.

Conditions

Dyslexia; Speech Therapy; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Speech Therapy INTENS-DYS

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Speech Therapy INTENS-DYS

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien BEVALOT

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

CHU de besançon

Besançon, , France

Countries

France

Other Identifiers

2022/692

Identifier Type: -

Identifier Source: org_study_id