The main purpose of this research is to investigate the effect of a training course of local adaptive games on motor skills, cognitive and behavioral characteristics in mentally retarded people. Determining the effect of a training course of local adaptive games on self-efficacy, aggression, adaptive behavior and motor skills of mentally retarded children.
Design
A clinical trial with a control group, with a parallel experimental group with a blind evaluator, randomized on 40 participants, was used to randomize the Random Allocation software.
Settings and conduct
This study will be held in schools for exceptional children in Chaharmahal and Bakhtiari province, where the evaluator will be blinded and will not know the results of the tests: the classes of the experimental group will be held for 3 months. Classes will include rhythmic games with music, local games.
Participants/Inclusion and exclusion criteria
Conditions for entering the intervention: children 8 to 12 years old studying in elementary schools for exceptional children in Chaharmahal and Bakhtiari provinces.
Conditions for not entering the intervention: children over 12 years old and higher than elementary school.
Intervention groups
The group of experimental interventions has three sessions per week for 12 weeks and the duration of the training is based on the complexity of the games, the amount of execution of the initial position, the range of movements, the distance and the amount of rest between exercises of 90 minutes. The control group will continue their routine life and only participate in the pre-test and post-test.
Main outcome variables
Raven's intelligence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220920055996N1
Registration date:2022-10-18, 1401/07/26
Registration timing:registered_while_recruiting
Last update:2022-10-18, 1401/07/26
Update count:0
Registration date
2022-10-18, 1401/07/26
Registrant information
Name
Fakhroldin Asadi Farsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
fakhroldin.asadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-15, 1401/07/23
Expected recruitment end date
2023-01-13, 1401/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a course of local adaptive games on basic skills, cognitive and behavioral characteristics in mentally retarded people.
Public title
The effect of a course of local adaptive games on basic skills, cognitive and behavioral characteristics in mentally retarded people.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of cardiovascular disease
Not having any neurological disorder
Not having movement problems and walking independently
Education in primary schools for exceptional children in Chaharmahal and Bakhtiari province
Having the criteria for diagnosing the disorder based on the cutoff score
Parental consent
Age 8 to 12 years
Exclusion criteria:
The occurrence of orthopedic problems for the participants
Parents' unwillingness to cooperate despite initial consent
Failure to attend the post-examination on time
The number of absences of more than 3 sessions during the exercise protocol
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two experimental groups and a control group with a 1:1 allocation ratio. Block randomization method will be used for random allocation of participants. The name of the software is random allocation software. We put the data into the software and then the software does it.
Blinding (investigator's opinion)
Single blinded
Blinding description
After allocation it was not possible to keep the trainer bilnd to each participant's allocated intervention. But the evalutor remained bilnd. According to the evaluator's opinion, this study was blinded in order not to enter incorrect information or borrowing that may occur in any person, so that it can be done without information about the purpose of this research and the purpose of the tests.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Khorasgan branch
Street address
University Blvd, Arghavanieh Ave, Eastern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.IAU.KHUISF.1398.097
Health conditions studied
1
Description of health condition studied
Mentally retarded children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The IQ of mentally retarded children
Timepoint
The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after 12 weeks of the end of the intervention.
Method of measurement
Using Raven's progressive matrices test in adult form
Secondary outcomes
1
Description
The level of self-efficacy of mentally retarded children
Timepoint
A pre-test will be taken in the first session and a post-test will be taken after 12 weeks of intervention.
Method of measurement
Wheeler and Led questionnaire will be used to measure self-efficacy.
2
Description
The level of aggression of mentally retarded children
Timepoint
A pre-test will be taken in the first session and a post-test will be taken after 12 weeks of intervention.
Method of measurement
Aggression questionnaire of mentally retarded children was used.
Intervention groups
1
Description
Intervention group: The experimental intervention group participated in the local indigenous exercises and games and rhythmic games and participated in the pre-test in the first session of the intervention and will participate in the post-test after 12 weeks at the end of the intervention.
Category
Rehabilitation
2
Description
Control group: In this group, there are no interventions and only at the beginning of the interventions, the intervention group will participate in the pre-test and after 12 weeks they will participate in the post-test.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Student Martyrs Sports Complex
Full name of responsible person
Alireza Talebi
Street address
Student Martyrs Sports Complex, Shohada Str, North Farabi Blvd, Shahre Kord
City
Shahre Kord
Province
Isfehan
Postal code
8814673137
Phone
+98 913 772 7719
Email
fakhroldin.asadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiyani
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fakhruddin Asadi Farsani
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fakhroldin Asadi Farsani
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
JQRM+HV3 Khorasgan, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
Email
fakhroldin.asadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Namazi zade
Position
Academic Staff, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd, Arghavanieh Ave, Estern Jey St, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
drmnamazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rokhsare Badami
Position
Academic Staff, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd, Arghavanieh Ave, Estern Jey St, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Rokhsareh.badami@khuisf.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file of the participants is in the form of a complete Excel, in which the children's history, underlying disease and surgical history, and the degree of mental retardation are fully stated. The informed consent form will be designed and available to each participant. After completing the intervention steps, a complete report of the clinical interventions will be prepared and documented in an accessible file.
When the data will become available and for how long
All the documentary files will be available after the interventions and after the results and approval of the relevant judges and professors and after printing.
To whom data/document is available
People related to this research will be allowed to access, such as supervisors and advisors and referees, in addition to the details of the participants, other researchers working in academic and scientific institutions will have the necessary access.
Under which criteria data/document could be used
Access to all parts of this study will be granted solely for treatment and to supplement and improve research.
From where data/document is obtainable
To get information, you can refer to the email address fakhroldin.asadi@yahoo.com.
What processes are involved for a request to access data/document
Applicants can access the information after one working week after entering the email to the entered email address.