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出境医 / 临床实验 / Developmental Dyslexia and Remediation Methods (DDMR)

Developmental Dyslexia and Remediation Methods (DDMR)

Study Description
Brief Summary:
At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation

Condition or disease Intervention/treatment Phase
Dyslexia, Developmental Other: Phonological Other: Visual-attention Not Applicable

Detailed Description:

Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus.

Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills.

In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation.

The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Phonological group Other: Phonological
  • Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
  • Phase 2: intervention with targeted daily training

    • Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
  • Phase 3: stopping training sessions for 8 weeks

Experimental: visual-attention group Other: Visual-attention
  • Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
  • Phase 2: intervention with targeted daily training

    • Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
  • Phase 3: stopping training sessions for 8 weeks

Outcome Measures
Primary Outcome Measures :
  1. reading skills effectiveness [ Time Frame: 26 weeks to baseline ]
    measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation


Secondary Outcome Measures :
  1. reading skills effectiveness 8 weeks [ Time Frame: 8 weeks to baseline ]
    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

  2. reading skills effectiveness 18 weeks [ Time Frame: 18 weeks to baseline ]
    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

  3. orthographic skills effectiveness [ Time Frame: 26 weeks to baseline ]
    count of orthographic (number of errors) in raw scores and standard deviation

  4. reading comprehension skills effectiveness [ Time Frame: 26 weeks to baseline ]
    measure of reading comprehension level (error rates) in raw scores and standard deviation

  5. perception of the evolution of the reading disorder [ Time Frame: 26 weeks to baseline ]

    measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13

    • Score from 5 to 1
    • For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1
    • The maximum value 5 means that reading and learning are perceived very positively
    • The minimum value 1 means that reading and learning are perceived very negatively
    • Results: An increase in scores measured before and after the three training sessions means an improvement


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 8 years old and ≤ at 13 years old;
  • Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.
  • Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.
  • Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.
  • Home equipped with a connected computer system for daily training.
  • Signing of informed consent by the parents
  • The child must be affiliated to a social security scheme

Exclusion Criteria:

  • Intellectual retardation, neurological disorders, pervasive developmental disorder;
  • Primary sensory deficit;
  • Educational deficiencies;
  • attention deficit hyperactivity disorder, dysphasia;
  • Previous daily phonological or visual-attentional training.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: HARRAR-ESKINAZI Karine 06 60 50 89 04 ext +33 karine.eskinazi@wanadoo.fr
Contact: Fossoud MD Catherine, MD fossoud.c@pediatrie-chulenval-nice.fr

Locations
Layout table for location information
France
Hôpitaux Pédiatriques de Nice CHU-Lenval Recruiting
Nice, France
Contact: Harrar Eskinazi Karine         
Principal Investigator: Harrar Eskinazi Karine         
Sponsors and Collaborators
Fondation Lenval
Investigators
Layout table for investigator information
Principal Investigator: HARRAR-ESKINAZI KARINE CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE October 25, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
reading skills effectiveness [ Time Frame: 26 weeks to baseline ]
measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • reading skills effectiveness 8 weeks [ Time Frame: 8 weeks to baseline ]
    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
  • reading skills effectiveness 18 weeks [ Time Frame: 18 weeks to baseline ]
    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
  • orthographic skills effectiveness [ Time Frame: 26 weeks to baseline ]
    count of orthographic (number of errors) in raw scores and standard deviation
  • reading comprehension skills effectiveness [ Time Frame: 26 weeks to baseline ]
    measure of reading comprehension level (error rates) in raw scores and standard deviation
  • perception of the evolution of the reading disorder [ Time Frame: 26 weeks to baseline ]
    measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13
    • Score from 5 to 1
    • For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1
    • The maximum value 5 means that reading and learning are perceived very positively
    • The minimum value 1 means that reading and learning are perceived very negatively
    • Results: An increase in scores measured before and after the three training sessions means an improvement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developmental Dyslexia and Remediation Methods
Official Title  ICMJE Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Brief Summary At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation
Detailed Description

Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus.

Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills.

In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation.

The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Dyslexia, Developmental
Intervention  ICMJE
  • Other: Phonological
    • Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
    • Phase 2: intervention with targeted daily training

      • Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
      • Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
      • Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Phase 3: stopping training sessions for 8 weeks
  • Other: Visual-attention
    • Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
    • Phase 2: intervention with targeted daily training

      • Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
      • Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
      • Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
    • Phase 3: stopping training sessions for 8 weeks
Study Arms  ICMJE
  • Experimental: Phonological group
    Intervention: Other: Phonological
  • Experimental: visual-attention group
    Intervention: Other: Visual-attention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 8 years old and ≤ at 13 years old;
  • Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.
  • Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.
  • Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.
  • Home equipped with a connected computer system for daily training.
  • Signing of informed consent by the parents
  • The child must be affiliated to a social security scheme

Exclusion Criteria:

  • Intellectual retardation, neurological disorders, pervasive developmental disorder;
  • Primary sensory deficit;
  • Educational deficiencies;
  • attention deficit hyperactivity disorder, dysphasia;
  • Previous daily phonological or visual-attentional training.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: HARRAR-ESKINAZI Karine 06 60 50 89 04 ext +33 karine.eskinazi@wanadoo.fr
Contact: Fossoud MD Catherine, MD fossoud.c@pediatrie-chulenval-nice.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028310
Other Study ID Numbers  ICMJE 19-HPNCL-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Lenval
Study Sponsor  ICMJE Fondation Lenval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: HARRAR-ESKINAZI KARINE CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
PRS Account Fondation Lenval
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP