Protocol summary

Study aim
Determining the effectiveness of perceptual-motor exercises of Johnston and Ramon and comparing it with motor activities based on video modeling on the motor development and executive function of children with learning disabilities aged 7-10 in Tehran
Design
A clinical trial with a control group, with a parallel group, randomized, a blind strain on 45 patients
Settings and conduct
This study will be conducted on 7 to 10-year-old students of schools with learning disabilities in Tehran. After checking the entry criteria, the samples will be randomly selected and divided into three groups. participants will not be aware of each other and the protocol of each other's interventions.
Participants/Inclusion and exclusion criteria
entry requirements: diagnosis of learning disorder No history of sports activity in the last 2 months Conditions of non-entry: history of physical and neurological diseases Taking sleeping pills
Intervention groups
The control group will be 15 people, the group with Johnston and Ramon movement perception exercises will be 15 people, and the group with movement exercises with video modeling will be divided into 15 people. From the samples before and after the intervention, the Gross Motor Skills Test (TGMD-2), Brief Executive Function Questionnaire, Wisconsin Test (2000) are taken. The training protocol of both groups is similar to each other and includes bilateral, unilateral, lateral cross and lateral superiority activities. But the execution method is different.
Main outcome variables
motor development (movement, object control) executive function (inhibition, transmission, emotion control, planning, organization, monitoring, working memory, initiation)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220718055489N1
Registration date: 2023-05-06, 1402/02/16
Registration timing: retrospective

Last update: 2023-05-06, 1402/02/16
Update count: 0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
Zeinab Dianatynasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3428 6144
Email address
z.dianatynasab@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-02, 1402/02/12
Expected recruitment end date
2023-05-06, 1402/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Johnston and Ramon motor perceptual exercises and motor activity with video modeling on motor development and executive function in children with learning disorders
Public title
The effectiveness of perceptual motor exercises compared to motor activity with video modeling on motor development and executive function of children with learning disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 7 to 10 with a diagnosis of learning disorder and obtaining consent from their parents No history of sports training in the last 2 months
Exclusion criteria:
History of physical and neurological diseases Taking sleeping pills and anticonvulsants
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Semnan University of medical science
Street address
Basij Blvd., Semnan University of Medical Sciences and Health Services
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.SEMUMS.REC.1401.069

Health conditions studied

1

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

2

Description of health condition studied
motor development disorder
ICD-10 code
F82
ICD-10 code description
Specific developmental disorder of motor function

Primary outcomes

1

Description
Motor development as measured by the Test of Gross Motor Skills - Second Edition
Timepoint
before interventions and after 2 months of intervention
Method of measurement
Test of gross motor skills (TGMD-2)

2

Description
Executive function
Timepoint
before interventions and after 2 months of intervention
Method of measurement
Executive Function Questionnaire (2000) BRIEF and Wisconsin Card Classification Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: performing perceptual-motor exercises 3 days a week for 2 months (each session 45 minutes) written based on the perceptual-motor model and the Johnston and Ramon protocol (promotes bilateral, unilateral, cross-lateral and lateral superiority activities) will be done. the equipment includes: balls, chalk, visual cards, glue, a number of obstacles and ropes
Category
Rehabilitation

2

Description
Intervention group: performing movement activities in the form of video modeling 3 days a week (each session is 45 minutes) for 2 months. Movement activities will be performed with the aim of improving bilateral, unilateral, cross-lateral and lateral superiority activities and body
Category
Rehabilitation

3

Description
Control group: During 2 months, she does not receive any movement exercises, only the Ulrich motor development test, brief executive function questionnaire and Wisconsin card classification test are taken from them before and after 2 months.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Exceptional Education
Full name of responsible person
Alireza Karimiyan
Street address
Shahid Jahormi Street،Ayatollah Kashani Boulevard ،second square of Sadeghieh
City
Tehran
Province
Tehran
Postal code
1481893631
Phone
+98 21 4407 6003
Email
dianatynasab.zeinab@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seifullah Saaduddin
Street address
first floor, the central organization of the university,in front of Sokan Park، semnan
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3365 4138
Fax
+98 23 3365 4136
Email
research.VC@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
semnan university
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
Semnan University of Medical Sciences
Full name of responsible person
Zeinab Dianaty nasab
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 7 , Block 22, West Fajr Third Street, Khatam town, Karaj
City
Karaj
Province
Alborz
Postal code
3159836653
Phone
+98 26 3428 6144
Email
Dianatynasab.zeinab@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zeinab Dianatynasb
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 7 , Block 22, West Fajr Third Street, Khatam town, Karaj
City
Karaj
Province
Alborz
Postal code
3159836653
Phone
+98 26 3428 6144
Email
Dianatynasab.zeinab@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zeinab Dianatynasab
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 7 , Block 22, West Fajr Third Street, Khatam town, Karaj
City
Karaj
Province
Alborz
Postal code
3159836653
Phone
+98 26 3428 6144
Email
Dianatynasab.zeinab@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
information about the number, age, sex and results of the Ulrich motor development test, the Wisconsin test and the brief executive function questionnaire (Parent form)
When the data will become available and for how long
The access period starts one week after the results are published
To whom data/document is available
The data will be accessible to all researchers in both academic and private sectors
Under which criteria data/document could be used
The data can be used for further research, provided that the reference is respected.
From where data/document is obtainable
Applicants should apply to the responsible email and explain the reason for the need for data dianatynasab.zeinab@yahoo.com Zainab Dianatynasab
What processes are involved for a request to access data/document
A response will be given to the applicant by email one week after sending the application
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