DyslexiaDyslexiaNCT04642859
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
A study testing Computerized Cognitive abilities training battery for reading (CATB-R) in people with Dyslexia, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 9 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Computerized Cognitive abilities training battery for reading (CATB-R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Student refused to participate
- Abnormal neurological, audiological or ophthalmological examination
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dyslexia
- Being tested
- Computerized Cognitive abilities training battery for reading (CATB-R)
- Keywords
- Dyslexia, Training, Egypt
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive abilities training battery for reading (CATB-R)Behavioural
Specially designed Arabic computerized training program for dyslexia
| Study group | Role | What they receive |
|---|---|---|
| Dyslexia | Experimental | Students with dyslexia before and after the intervention Receives: Behavioral: Computerized Cognitive abilities training battery for reading (CATB-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 2 months
Secondary outcomes (1)
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
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start14 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- compare scores before and after the intervention
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Osama Aboshaera, Assiut University
- Investigators
- Wafaa M Farghaly, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642859
- Sponsor's protocol ID
- AssiutU Dyslexia
- Acronym
- Dyslexia
- Status last verified
- Apr 2022
- First submitted
- 12 Nov 2020
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
- ClinicalTrials.gov ID
- NCT04642859
- Acronym / sponsor ID
- Dyslexia / AssiutU Dyslexia
- Conditions
- Dyslexia
- Keywords
- Dyslexia, Training, Egypt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- compare scores before and after the intervention
| Arm | Type | Receives |
|---|---|---|
| Dyslexia | Experimental | Behavioral: Computerized Cognitive abilities training battery for reading (CATB-R)Students with dyslexia before and after the intervention |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Student refused to participate
- Abnormal neurological, audiological or ophthalmological examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive abilities training battery for reading (CATB-R)Specially designed Arabic computerized training program for dyslexia | Behavioural | Dyslexia |
Primary outcome
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: 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)
1 secondary outcome
Change in Computerized Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R)
Time frame: Baseline, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa M Farghaly, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive abilities training battery for reading (CATB-R) in people with Dyslexia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arabic Reading Achievement test (RAT) (time frame: Baseline, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.