Protocol summary

Study aim
Determining the effectiveness of remote occupational therapy on the visual-motor skills of children with special learning disorders in elementary school.
Design
A clinical trial with a control group, as a single blind strain, randomized by random blocks using spss, is conducted on 40 patients.
Settings and conduct
Place of study: Mehr rehabilitation center in Tehran; Study population: includes 40 children with learning disabilities; Type of blinding: Single-blind; The method of blinding: the assessor is unaware of the people in the experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: second, third and fourth grade; have been admitted with a special learning disorder diagnosis; they have only benefited from educational interventions and have not received rehabilitation services; In the medical records of these children, the health of their sight and hearing has been reported; The IQ of these children is normal based on the Wechsler IQ scale. Non-inclusion criteria: not understanding the language commands, not wanting to participate in the study, getting a score above the average in the TVMS_R test.
Intervention groups
Intervention group: 20 children with learning disabilities that receive occupational therapy services remotely through video call. Control group: 20 children with learning disabilities; that not receive any rehabilitation intervention.
Main outcome variables
visual-motor skills, visual-spatial skills

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230405057825N1
Registration date: 2023-07-11, 1402/04/20
Registration timing: registered_while_recruiting

Last update: 2023-07-11, 1402/04/20
Update count: 0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Mohsen Taheri ruh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4496 7784
Email address
moh.taheri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Tele-occupational therapy on Visual-Motor Skills in children with specific learning disorder in elementary school
Public title
The effectiveness of Tele-occupational therapy in children with specific learning disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The second, third and fourth grade of elementary school have been diagnosed with a special learning disorder In the medical records of these children, the health of their sight and hearing should be reported The IQ of these children must be normal based on the Wechsler IQ scale In the TVMS_R test, in each of the eight classes, they must have obtained a score lower than the average and norm.
Exclusion criteria:
Lack of understanding of language commands Unwillingness to participate in the study Getting a score above the average in the TVMS_R test
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
By random number table: this table is a collection of numbers that are generated without a specific pattern or order and in a completely random manner, and it is in the form of a table. In order to use the table of random numbers, we must first determine the direction of reading the table numbers (for example, up, down, left or right), the second assumption is to consider numbers for different groups (for example, even numbers for intervention A and odds numbers for intervention B) and in this way we define the intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation is done by a qualified person in a blinded manner, and the evaluator is unaware of the people in the experimental and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
The end of the sixth alley; Valenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.USWR.REC.1401.243

Health conditions studied

1

Description of health condition studied
specific learning disorder
ICD-10 code
F81
ICD-10 code description
Specific developmental disorders of scholastic skills

Primary outcomes

1

Description
The score of visual-motor skills in the Test of Visual-Motor Skills-Revised
Timepoint
Measurement of visual-motor skills at the beginning of the study (before the start of the intervention) and after 8 weeks (16Tele-occupational therapy sessions) at the end of the intervention period.
Method of measurement
Test of Visual-Motor Skills-Revised

2

Description
The score of visual-spatial skills in the Test of Visual-Motor Skills-Revised
Timepoint
Measurement of visual-spatial skills at the beginning of the study (before the start of the intervention) and after 8 weeks (16Tele-occupational therapy sessions) at the end of the intervention period.
Method of measurement
Test of Visual-Motor Skills-Revised

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Tele Occupational therapy; Providing occupational therapy services in the field of eye movements, visual-spatial skills, visual analysis and visual-motor integration by video call and without any physical contact with clients with the help of smartphones or computers in 16 30-minute sessions, twice a week. Exercises are taught to the children and the parents remotely through pictures and videos, and then the exercises is monitored by video call.
Category
Rehabilitation

2

Description
Control group: Not any rehabilitation intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Rehabilitation center
Full name of responsible person
DR. Fatorechy
Street address
Mehr Rehabilitation center, 14th Alley, Intersection of Khoi Street with Abuzar Ghaffari Street, Tehran
City
Tehran
Province
Tehran
Postal code
1481713861
Phone
+98 21 2284 3325
Email
saeidfatorehchy@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
HamidReza Khankeh
Street address
The end of the sixth alley; Valenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 922 218 0083
Email
hamid.khankeh@ki.se
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mohsen TaheriRuh
Position
Master student in Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
The end of the sixth alley; Valenjak
City
Teharn
Province
Tehran
Postal code
1985713871
Phone
+98 917 781 2684
Email
mohsentaheriruh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen TaheriRuh
Position
Master student in Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
The end of the sixth alley; Valenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 917 781 2684
Email
mohsentaheriruh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen TaheriRuh
Position
Master student in Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
The end of the sixth alley; Valenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 917 781 2684
Email
mohsentaheriruh@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
The results of the assessment can be shared without mentioning the traceable characteristics of the individuals
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
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can be used for other studies under the supervision of academic and scientific institutions without special conditions
From where data/document is obtainable
Through sending email to: mohsentaheriruh@gmail.com
What processes are involved for a request to access data/document
It will be sent to the person at most one month after confirming the correctness of the applicant's information
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