Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children. (INTENS-DYS)
30. maj 2022 opdateret af: Centre Hospitalier Universitaire de Besancon
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sofiane ZIAMNI
- Telefonnummer: +33381218988
- E-mail: sziamni@chu-besancon.fr
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reading fluency to the Alouette test.
Tidsramme: Six month.
|
Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.
|
Six month.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phonological processing tests.
Tidsramme: Six month.
|
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.
Tidsramme: Six month.
|
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.
Tidsramme: 6 month.
|
Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.
|
6 month.
|
|
Rehabilitation adhesion.
Tidsramme: 6 month
|
Number of speech therapy session performed by patient in each arms.
|
6 month
|
|
Speech langage rehabilitation cost.
Tidsramme: 6 month.
|
Differential cost/progress relation of intensive and classical rehabilitation.
|
6 month.
|
|
Family and school evaluation.
Tidsramme: 6 month.
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Julien BEVALOT, CHU De Besancon
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juli 2022
Primær færdiggørelse (Forventet)
1. juli 2023
Studieafslutning (Forventet)
1. juli 2024
Datoer for studieregistrering
Først indsendt
17. maj 2022
Først indsendt, der opfyldte QC-kriterier
17. maj 2022
Først opslået (Faktiske)
20. maj 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022/692
Plan for individuelle deltagerdata (IPD)
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