Comparing the effect of tele-occupational therapy and face-to-face occupational therapy on improving reading in children with dyslexia in primary school
Comparing the effect of Tele-occupational therapy and face-to-face occupational therapy on improving reading in children with dyslexia in primary school
Design
The clinical trial with a control group, with intervention groups, a blinded, randomized phase 0 on 30 dyslexic children, will be used for randomization using the random block method with the help of the blokrand function in R 4.2.2 software.
Settings and conduct
The research in the field of working memory and attention in order to improve reading comprehension and reading of dyslexic children will be done in Haft Seng Institute and Sampling will be done from learning disorder centers. Dyslexic children will be randomly divided into two groups by an uninformed expert using the blokrand function.
Participants/Inclusion and exclusion criteria
1. The second, third and fourth grade.
2. Diagnosis of special learning disorder by a psychiatrist
3. Informed consent of parents to enter the research
4. Not suffering from other disorders along with special learning disorder
Intervention groups
The control group of dyslexic children who receive face-to-face occupational therapy interventions and the experimental group of dyslexic children who receive remote occupational therapy interventions through video call in the field of working memory and attention. Interventions will be provided in 14 sessions of 45 minutes in each two groups.
Main outcome variables
The main outcome of the intervention is the effect on working memory, attention and comprehension on improving the reading of children with dyslexia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240527061919N1
Registration date:2024-10-18, 1403/07/27
Registration timing:prospective
Last update:2024-10-18, 1403/07/27
Update count:0
Registration date
2024-10-18, 1403/07/27
Registrant information
Name
Zeynab Moravvej
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 6001
Email address
zey.moravvej@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-21, 1403/07/30
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of tele-occupational therapy and face-to-face occupational therapy on improving reading in children with dyslexia in primary school
Public title
The effectiveness of tele-occupational therapy compared to face-to-face occupational therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be second, third and fourth grade
A diagnosis of special learning disorder has been mentioned by a psychiatrist
Parents must have informed consent to enter the research
Exclusion criteria:
Having other disorders along with learning disorder
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into two groups using the random block method with the help of the blokrand function in R 4.2.2 software.
It is worth noting that randomization will be done in the following arrangement: B B A A A B A B B A B A B A A B A B B B A A A B A B B B A; where B will represent placement in the test group and A will represent placement in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the research will enter the research knowingly. A pre-test will be taken from all participants in the study to enter the study. None of the participants will know how to be placed in the groups and the type of group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Social Welfare and Rehabilitation Sciences university
Street address
University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-09-28, 1403/07/07
Ethics committee reference number
IR.USWR.REC.1403.137
Health conditions studied
1
Description of health condition studied
Dyslexia
ICD-10 code
R48.0
ICD-10 code description
Dyslexia and alexia
Primary outcomes
1
Description
Working memory
Timepoint
The first, middle and final session of the research
Method of measurement
Cantab test sub-test of spatial working memory
2
Description
Attention
Timepoint
The first, middle and final session of the research
Method of measurement
Cantab test sub-test of intra-dimensional/extra-dimensional shift
3
Description
Comprehension
Timepoint
The first, middle and final session of the research
Method of measurement
reading and dyslexia test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: clients with dyslexia who receive occupational therapy interventions in person. Interventions in the control group will be provided face-to-face by the therapist in 14 45-minute sessions. Before allocating people to two groups, there will be a pre-test and a post-test at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be considered to ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and in order to improve and understand the content.
Category
Rehabilitation
2
Description
Intervention group: Clients with dyslexia who receive occupational therapy interventions remotely. Interventions of the experimental group will be provided in the form of video calls and providing interventions from behind the phone and explanations to parents in 14 sessions of 45 minutes. Before assigning people to two groups, a pre-test and a post-test will be taken at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be held in person to evaluate and ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and to improve reading and comprehension.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahan Rehabilitation Center
Full name of responsible person
Mahdi Karami
Street address
No. Second floor , 5 , in front of the door of Shariat Razavi Hospital., Shahid Abdollahi Street., South Mehrabad
City
Tehran
Province
Tehran
Postal code
1385674931
Phone
+98 21 6663 4409
Email
m.karami453@gmail.com
2
Recruitment center
Name of recruitment center
Tavanafarin Rehabilitation Clinic
Full name of responsible person
Mozhgan Kabki
Street address
No. 3rd floor, 168 , next to gas station., in front of 4th Niro Air Force., Pirozi St., niroohavayi
City
Tehran
Province
Tehran
Postal code
1766745754
Phone
+98 21 7741 7958
Email
Mozhgankabki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohamad Saeed Khanjani
Street address
University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Fax
Email
sa.khanjani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zeynab moravvej
Position
Occupational therapist
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
Zeynabmoravvej78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ghazale mandani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Daneshjo Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0037
Email
ghazal.mandani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zeynab Moravvej
Position
Occupational therapist
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
Zeynabmoravvej78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Research data.
The data will only be made available to professors and principal researchers.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be in the hands of the original researchers, and after the work is completed, the results will be published in authoritative articles.
Under which criteria data/document could be used
In case, non-identifiable data will be provided to people for research in line with the continuation of said research.
From where data/document is obtainable
To receive the data, they can refer to Dr. Ghazaleh Mandani.
Address: Occupational Therapy Training Group., university of social welfare and rehabilitation sciences ., dead end kodakyar., daneshjo blv., velenjak., tehran
Postal code: 1985713871
Email: ghazal.mandani@gmail.com
What processes are involved for a request to access data/document
After sending the data application request, if approved by the professors, the data file will be sent. It will take at least one month from the time of sending the confirmation of the data request application to the sending of the data.