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Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt (Dyslexia)

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computerized Cognitive abilities training battery for reading (CATB-R)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring Dyslexia, Training, Egypt

Eligibility Criteria

8 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dyslexia

Arm Description

Students with dyslexia before and after the intervention

Outcomes

Primary Outcome Measures

Change in Arabic Reading Achievement test (RAT)
new scale of Arabic Reading Achievement test specially designed for this study. Students will classified according to their achievement level into three groups: Group I: Poor achievers (scores < mean - SD), considered students with reading disability, or dyslexia Group II: Average achievers (with scores= mean + SD) Group III included those with good achievement (score > mean+ SD)

Secondary Outcome Measures

Change in Computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R)
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: Text Reading comprehension Visual discrimination Auditory discrimination Phonological awareness Visuospatial skills Audio-Visual correspondence Auditory memory

Full Information

First Posted
November 12, 2020
Last Updated
April 30, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04642859
Brief Title
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
Acronym
Dyslexia
Official Title
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 14, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
This study will be carried out along seven stages; 1- Identification of students with reading disability using Arabic Reading Achievement test (RAT); 2- Construction of a computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R); 3- Standardization of the constructed battery; 4- Detailed study of the cognitive profile; 5- Construction of a Computerized Cognitive abilities training battery for reading (CATB-R); 6- Application of the training battery; 7- Reassessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia
Keywords
Dyslexia, Training, Egypt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
compare scores before and after the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dyslexia
Arm Type
Experimental
Arm Description
Students with dyslexia before and after the intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive abilities training battery for reading (CATB-R)
Intervention Description
Specially designed Arabic computerized training program for dyslexia
Primary Outcome Measure Information:
Title
Change in Arabic Reading Achievement test (RAT)
Description
new scale of Arabic Reading Achievement test specially designed for this study. Students will classified according to their achievement level into three groups: Group I: Poor achievers (scores < mean - SD), considered students with reading disability, or dyslexia Group II: Average achievers (with scores= mean + SD) Group III included those with good achievement (score > mean+ SD)
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
Title
Change in Computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R)
Description
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: Text Reading comprehension Visual discrimination Auditory discrimination Phonological awareness Visuospatial skills Audio-Visual correspondence Auditory memory
Time Frame
Baseline, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaa M Farghaly, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
17777
Country
Egypt

12. IPD Sharing Statement

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Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt

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