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

Centre Hospitalier Universitaire de Besancon

Status: Terminated

Conditions: Speech Therapy; Children, Only; Dyslexia

Treatments: Other: Speech Therapy INTENS-DYS

Study type: Interventional

Funder types: Other

Identifiers

NCT05383937

2022/692

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

intensive arm

Experimental group

Description:

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.

Treatment:

Other: Speech Therapy INTENS-DYS

classic arm or gold standard

Active Comparator group

Description:

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.

Treatment:

Other: Speech Therapy INTENS-DYS