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

Primary Purpose

Dyslexia, Speech Therapy, Children, Only

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Speech Therapy INTENS-DYS
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring Dyslexia, Speech Therapy, Children, Intensive rehabilitation

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intensive arm

    classic arm or gold standard

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 17, 2022
    Last Updated
    May 30, 2022
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05383937
    Brief Title
    Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
    Acronym
    INTENS-DYS
    Official Title
    Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslexia, Speech Therapy, Children, Only
    Keywords
    Dyslexia, Speech Therapy, Children, Intensive rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intensive arm
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    classic arm or gold standard
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Speech Therapy INTENS-DYS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Reading fluency to the Alouette test.
    Description
    Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.
    Time Frame
    Six month.
    Secondary Outcome Measure Information:
    Title
    Phonological processing tests.
    Description
    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.
    Time Frame
    Six month.
    Title
    Visual pattern.
    Description
    Difference in the number of errors to five visual pattern from the BALE and the EVALEO, in the intensive and the conventional arm.
    Time Frame
    Six month.
    Title
    Life Quality.
    Description
    Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.
    Time Frame
    6 month.
    Title
    Rehabilitation adhesion.
    Description
    Number of speech therapy session performed by patient in each arms.
    Time Frame
    6 month
    Title
    Speech langage rehabilitation cost.
    Description
    Differential cost/progress relation of intensive and classical rehabilitation.
    Time Frame
    6 month.
    Title
    Family and school evaluation.
    Description
    Difference to Visual Analog Scale (VAS) regarding the benefit of speech therapy rehabilitation, assessed by the family and the school teachers, in each arms.
    Time Frame
    6 month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofiane ZIAMNI
    Phone
    +33381218988
    Email
    sziamni@chu-besancon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Astrid POZET
    Phone
    +33381218988
    Email
    apozet@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julien BEVALOT
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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