NCT04642859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 12, 2020

Last Update Submit

April 30, 2022

Conditions

Keywords

DyslexiaTrainingEgypt

Outcome Measures

Primary Outcomes (1)

  • 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: 1. Group I: Poor achievers (scores \< mean - SD), considered students with reading disability, or dyslexia 2. Group II: Average achievers (with scores= mean + SD) 3. Group III included those with good achievement (score \> mean+ SD)

    Baseline, 2 months

Secondary Outcomes (1)

  • Change in Computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R)

    Baseline, 2 months

Study Arms (1)

Dyslexia

EXPERIMENTAL

Students with dyslexia before and after the intervention

Behavioral: Computerized Cognitive abilities training battery for reading (CATB-R)

Interventions

Specially designed Arabic computerized training program for dyslexia

Dyslexia

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • nd-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

You may not qualify if:

  • Student refused to participate
  • Abnormal neurological, audiological or ophthalmological examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 17777, Egypt

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wafaa M Farghaly, MD

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: compare scores before and after the intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 24, 2020

Study Start

November 14, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations