Protocol summary

Study aim
A comparative study of the effectiveness of computer-based cognitive rehabilitation and game-based neuropsychological rehabilitation on the improvement of specific learning disorder
Design
Randomized control trial
Settings and conduct
Pre-test and post-test in Tehran, Iran
Participants/Inclusion and exclusion criteria
1. Receive a diagnosis of a specific learning disorder 2. Informed consent of parents to participate in the research 3. Being in the age range of 6 to 12 years
Intervention groups
Computer-based cognitive rehabilitation group: This group will undergo a computerized intervention using the Captain Log program in 25 sessions. Game-based neuropsychological rehabilitation group: This group will undergo a neuropsychological rehabilitation program using physical games in 25 sessions. Control group: This group will not receive any intervention.
Main outcome variables
cognitive and psychological

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230416057922N1
Registration date: 2023-10-18, 1402/07/26
Registration timing: prospective

Last update: 2023-10-18, 1402/07/26
Update count: 0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Asgar Alimohmadi
Name of organization / entity
Allameh Tabataba'I University
Country
Iran (Islamic Republic of)
Phone
+98 21 4839 3194
Email address
alimohamadi@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of computer-assisted cognitive rehabilitation and game-based neuropsychological rehabilitation for students with specific learning disabilities
Public title
computer-assisted cognitive rehabilitation and game-based neuropsychological rehabilitation for students with specific learning disabilities
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The revised main criteria for entering the study are as follows 1. Being between the ages of 6 and 12 years old 2. Meeting the criteria for a specific learning disorder as diagnosed by a specialist 3. Obtaining informed consent from parents to participate in the study
Exclusion criteria:
comorbid disorders such as ADHD and drug use existence of severe language and non-verbal problems as diagnosed by the psychologist
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 153
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into two intervention groups and one control group using a randomization sequence that will be created beforehand. This sequence will be completely random and unpredictable. To allocate the participants, a block randomization method will be employed, involving 9 blocks. By utilizing random number generation software with the block method, the randomization sequence will be generated based on the required sample size for the two groups. The process of assigning participants to groups will be facilitated by a software called Sealed Envelope. Additional Information: In order to generate the list, we take into account 9 different block sizes and a total list length of 153. Within the treatment groups, we have three specific groups: Group A, Group B, and Group C. Using the software, we create 10 blocks, each containing 9 options. Out of the total 153 codes, 51 will be assigned to Group A, 51 to Group B, and 51 to Group C. This software ensures that concealment is maintained during the allocation process. Concealment refers to the unpredictability of assigning individuals to specific groups. It means that the researcher will not be able to predict which group the next person will be assigned to. This helps to minimize any potential bias or influence in the allocation process, ensuring a fair and unbiased distribution of participants across the interventions and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The committee of ethics in research of Allameh Tabatabai University
Street address
Iran. Tehran, Dehkadeh olampic
City
tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.ATU.REC.1402.026

Health conditions studied

1

Description of health condition studied
specific learning disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
executive function
Timepoint
pre test-post test
Method of measurement
In this research, executive function tools including the Continuous Attention Test, BRIEF2 Test, Working Memory Test, and Motor Skills Test will be used.

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
Intervention group: The group received computer-based cognitive rehabilitation with a designed package for two months. This intervention is done in 25 sessions. These interventions are received by a computer called Captain Log. Games and activities that require a computer and the program is installed on it. Usually, each activity lasts between 20 and 45 minutes. Captain Log contains motivational and entertaining videos. By activating the brain reward cycle, the exercises and training patterns of the software lead to encouraging people to improve and improve their performance. Visual recognition, auditory recognition, number perception, sequential conceptual patterns and types of memory ( visual memory), (auditory memory), (active memory), (memory sequence).- Captain's Log cognitive software first conducts a 9-step test for the person according to the specified age of the client, The report of the person's acceptance in each of the nine stages of the test and the report of the average response time to the test questions (Reaction Time) and a complete comparison chart are provided to the examiner. In the next step, the examiner can use the treatment program recommended by the software. The application will have, according to the test performed a customized plan chosen by the therapist from among about 50 types of exercises in 3 different levels (about 150 exercises).
Category
Rehabilitation

2

Description
Intervention group: The game-based neuropsychological rehabilitation group receives the designed package during two months, which is 25 sessions of 45 groups and is held 4 times a week. This program tries to improve children's cognitive and psychological functions through games and exercises. Hasanalizadeh et al. (2017) have used this program in 16 sessions to improve the psychological functions of children with developmental delay.
Category
Rehabilitation

3

Description
Control group: routin education
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Exceptional Education Organization
Full name of responsible person
Asgar Alimohamadi
Street address
Iran-Tehran-Dehkadeh Olampic
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3194
Email
asgar.alimohamadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Asgar Alimohamadi
Street address
Dehkade-olampic
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3194
Email
alimohamadi@atu.ac.ir
Grant name
Office of reserch of Allameh Tabataba'i University
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Asgar Alimohamadi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dehkade olampic
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3194
Email
asgar.alimohamadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
َAsgar Alimohamadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dehkadeh olampic
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3194
Email
asgar.alimohamadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Asgar Alimohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dehkadeh olampic
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3194
Email
asgar.alimohamadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Quantitative Data
When the data will become available and for how long
After publishing
To whom data/document is available
will be accessible based on email request
Under which criteria data/document could be used
analyzing
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
mail
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