- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04642859
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt (Dyslexia)
Dyslexia is a specific learning disability that is neurological in origin. It is characterized by difficulties with accurate or fluent word recognition, by poor spelling and decoding abilities, difficulty reading words in isolation and difficulty with oral reading (slow, inaccurate, or labored). These difficulties typically result from a deficit in the phonological component of language that is often unexpected with other cognitive abilities and the provision of effective classroom instruction. The phonological deficit hypothesis is the dominant explanatory theory of developmental dyslexia. Despite this, impaired phonological processing alone cannot explain all clinical symptoms of dyslexia. Many students with dyslexia have multiple deficits other than phonological deficits. Of these accused deficits are visual perceptual processing deficits, auditory processing deficits, multisensory spatial attention deficits as well as cerebellar dysfunction. The current mandatory criterion for the diagnosis of dyslexia, below-average achievement, implies waiting to failure. This approach for diagnosis (must fail approach) would delay intervention for rehabilitation.
Furthermore, the cut-off scores would result in over or under inclusion of cases and appear to be the least reliable and valid approach to diagnosis. Both methods lack a deeper understanding of the underlying reading difficulty, their neurobiological basis, and hence represent barriers against scientifically-based interventions. However, improved understanding of the neurobiological basis of dyslexia will facilitate evidence-based effective intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 17777
- Assiut University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 2nd-grade primary school students
- Poor scholastic achievement: less than mean - SD score on Arabic reading achievement test
- Normal neurological, basic audiological, and ophthalmological examination
- Both sexes included
Exclusion Criteria:
- Student refused to participate
- Abnormal neurological, audiological or ophthalmological examination
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dyslexia
Students with dyslexia before and after the intervention
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Specially designed Arabic computerized training program for dyslexia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Arabic Reading Achievement test (RAT)
Time Frame: Baseline, 2 months
|
new scale of Arabic Reading Achievement test specially designed for this study. Students will classified according to their achievement level into three groups:
|
Baseline, 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R)
Time Frame: Baseline, 2 months
|
Specially designed battery in a game-like manner to test a wide range of cognitive skills that are supposed to be important in the early stages of learning to read. It includes the following skills:
|
Baseline, 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wafaa M Farghaly, MD, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutU Dyslexia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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