evaluate the effectiveness of brailletonik, treadmill and computer games exercises on executive functions, social and motor skills of mentally retarded children.
Design
The statistical sample of this study will be selected from mentally retarded children referring to Kahrizak Rehabilitation Center in Alborz province in the academic year of 97-98. This study will be consisted of 32 educable girls with intellectual disability that randomly are placed into 4 groups of computer games, brailletonik exercises, treadmill exercises and control. A game that included a variety of puzzles will be presented to the computer game group for 45 minutes. The brailletonik team will perform exercises such as warm-up, use of coding, use of six squares, and cooling over 45 minutes. The treadmill group will do warm-up, children's treadmill exercises, and cooled down for 45 minutes.
Settings and conduct
All stages of this research will be carried out from sample selection to data collection at Kahrizak Rehabilitation Center in Alborz province in the academic year 98-97.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Diagnosis of mentally retarded disorder of educational type (IQ score between 50 and 70)
2. Female gender
3. Age range from 8 to 11 years
4- Being matched in terms of motor development
Intervention groups
A game that included a variety of puzzles will be presented to the computer game group for 45 minutes. The brailletonik team will perform exercises such as warm-up, use of coding, use of six squares, and cooling over 45 minutes. The treadmill group will do warm-up, children's treadmill exercises, and cooled down for 45 minutes.
Main outcome variables
executive functions, social and motor skills of mentally retarded children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190802044406N1
Registration date:2020-01-16, 1398/10/26
Registration timing:retrospective
Last update:2020-01-16, 1398/10/26
Update count:0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Manizhe Ghassemi
Name of organization / entity
Khurazmi university of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 5014
Email address
std_ghassemi.m93@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Brailletonik exercises, treadmill and computer games on executive functions, motor and social skills of mentally retarded children
Public title
The effect of Brailletonik exercises, treadmill and computer games on executive functions, motor and social skills
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Educable Mental Disability (IQ score between 50 and 70)
Female gender
Age range from 8 to 11 years
Peer in terms of motor development
Exclusion criteria:
Diagnosis of any illness or mental and physical disorder (other than mental retardation) that may affect research results, such as the diagnosis of head trauma or symptoms of psychosis.
Age
From 8 years old to 11 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be based on randomized block design with block size 4 (using table of random permutations) and assignment ratio of 1: 1. To ensure that the assignment to each group will be kept confidential, after randomization, participants' codes will be covered by closed envelopes by a person who that unaware of the purpose of study. Until the intervention of the researcher and the participant, he or she will do not know in which group he will be placed. Subjects will be randomly divided into four groups of eight (8 in the Brailltonic group, 8 in the treadmill group, 8 in the computer game group, and 8 in the control group).
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 Tarbiat Modarres University
Street address
Jalal Ale Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.MODARES.REC.1398.025
Health conditions studied
1
Description of health condition studied
Mental retardation
ICD-10 code
F70
ICD-10 code description
Mild mental retardation
Primary outcomes
1
Description
Executive functions
Timepoint
At baseline and 60 days later
Method of measurement
stroop
2
Description
Motor skills
Timepoint
At baseline and 60 days later
Method of measurement
Continuous Performance Test
3
Description
social skill
Timepoint
At baseline and 60 days later
Method of measurement
Vineland Adaptive Behavior Scale
Secondary outcomes
empty
Intervention groups
1
Description
In this group, Brailletonic exercises will be used for intervention. Brighton exercises such as warm-up, coding, using six squares, and cooling will be performed for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker.
Category
Rehabilitation
2
Description
In this group, treadmill exercises will be used for intervention. The group Ventures warm-ups, treadmill training, and cooling down for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker.
Category
Rehabilitation
3
Description
In this group, the intervention will be a computer game. Computer gaming is a type of interactive entertainment performed by an electronic device equipped with a processor or micro controller. These types of games based on the style of play and graphics are divided into different forms, such as educational, racing, sports, etc. In this group, the game will be adapted from a puzzle game of type Farm and Castles 1.2 8.5473.21-2 for 45 minutes.
Category
Rehabilitation
4
Description
The control group will received no intervention and its members will be performed the same routine procedure as the center.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Rehabilitation Center
Full name of responsible person
Manizhe Ghasemi
Street address
Mohammad Shahr, end of Golestanak street, at the beginning of Esfahani street
City
Mohammadshahr
Province
Alborz
Postal code
31845-167
Phone
+98 26 3630 9171
Fax
+98 26 3630 1859
Email
Kahraj@kahrizak.com
Web page address
http://kahrizak.com/contact-us/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khurazmi university of Tehran
Full name of responsible person
Manizhe Ghasemi
Street address
Khurazmi university
City
Karaj
Province
Alborz
Postal code
15719-14911
Phone
+98 21 8832 9222
Fax
+98 21 8832 9222
Email
info@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه خوارزمی
Proportion provided by this source
10
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kharazmi University of Tehran
Full name of responsible person
Manizhe Ghasemi
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
Kharazmi University
City
Karaj
Province
Alborz
Postal code
31979-37551
Phone
+98 26 3457 5014
Fax
+98 26 3457 5014
Email
std-Ghasemi.m93@khu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University of Tehran
Full name of responsible person
Manizhe Ghasemi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
Kharazmi University
City
Karaj
Province
Alborz
Postal code
31979-37551
Phone
+98 26 3455 0702
Fax
+98 26 3455 0702
Email
std-ghassemi.m93@khu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University of Tehran
Full name of responsible person
Manizhe Ghasemi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
Kharazmi University
City
Karaj
Province
Alborz
Postal code
31979-37551
Phone
+98 26 3455 0702
Fax
+98 26 3455 0702
Email
std-Ghassemi.m93@khu.ac.ir
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
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