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

NCT05383937 | Terminated

• 1 other identifier: 2022/692
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Dyslexia; Speech Therapy; Children; Intensive rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Phonological processing tests.

  Six month.

• Visual pattern.

  Six month.

• Life Quality.

  6 month.

• Rehabilitation adhesion.

  6 month

• Speech langage rehabilitation cost.

  6 month.

Study Arms (2)

intensive arm

EXPERIMENTAL

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

classic arm or gold standard

ACTIVE COMPARATOR

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

Interventions

Speech Therapy INTENS-DYS 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; intensive arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de besançon

Besançon, France

Location

MeSH Terms

Conditions

Dyslexia; Communication Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Julien BEVALOT

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: October 10, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)