Determination of the Effect of Shofer video game on Visual-Motor Coordination in Hearing Damaged Children
Design
Clinical trial with control group, no blind, randomized
Settings and conduct
Ahvaz , school for children with special needs, preschool
Participants/Inclusion and exclusion criteria
Children with hearing impairment in preschool degree in a school for children with special needs
Intervention groups
The experimental group performed a computer game with two separate laptops for 5 weeks, twice a week (Saturday and Tuesday) and 45 minutes each time.
The control group did not receive any intervention.
Main outcome variables
Eye and hand coordination; clean shape of the field; understanding shape stability; clean atmosphere in space; understanding spatial relationships; correct answer; error of negligence; committing error; reaction time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140618018150N3
Registration date:2018-06-23, 1397/04/02
Registration timing:retrospective
Last update:2018-06-23, 1397/04/02
Update count:0
Registration date
2018-06-23, 1397/04/02
Registrant information
Name
Rita Rezaee
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 33064
Email address
ritarezaee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-03-06, 1396/12/15
Trial completion date
empty
Scientific title
The Effect of Shofer Video Game on Visual-Motor Coordination in Hearing Impaired Children
Public title
Effect of video games on visual-motor coordination
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Studying at advanced level in preparation
The lack of learning difficulty
The lack of medical problems that prevent research
The child's willingness to participate in the intervention
Parental Satisfaction
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Actual sample size reached:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be assigned to experimental and control groups based on the randomized blocking method with 4 individuals per block and the randomized pattern A B A B B A B A A B B A A B B.
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 Shiraz University of Medical Sciences
Street address
6th Floor, Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SUMS.REC.1396.178
Health conditions studied
1
Description of health condition studied
Visual-motor coordination
ICD-10 code
R27.9
ICD-10 code description
Unspecified lack of coordination
Primary outcomes
1
Description
Visual perception
Timepoint
Before and after intervention
Method of measurement
Frostig Developmental Test of Visual Perception
2
Description
attention
Timepoint
Before and after intervention
Method of measurement
Continuous Performance Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive game interventions for 10 sessions, 2 sessions per week, 45 minutes per session, Individually
Category
Rehabilitation
2
Description
Control group: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali's school
Full name of responsible person
Zahra Norouzi Tabrizi Nejad
Street address
Primary school of Imam Ali, Sina Blvd, Phase 2 of Padadshahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6187784331
Phone
+98 61 3559 4347
Email
zahra.tab92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rita Rezaee
Street address
6th Floor, Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2884
Fax
+98 71 3235 6996
Email
ritarezaee@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Norouzi Tabrizi Nejad
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Diamond Building, Alley 29, Three Palestine Roads and Mulla Sadra Four Way, Qasraldasht Street
City
Shiraz
Province
Fars
Postal code
7133654361
Phone
+98 71 3234 0774
Email
zahra.tab92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rita Rezaee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Diamond Building, Alley 29, Three Palestine Roads and Mulla Sadra Four Way, Qasraldasht Street
City
Shiraz
Province
Fars
Postal code
7133654361
Phone
+98 71 3234 0774
Email
ritarezaee@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Norouzi Tabrizi Nejad
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Diamond Building, Alley 29, Three Palestine Roads and Mulla Sadra Four Way, Qasraldasht Street
City
Shiraz
Province
Fars
Postal code
7133654361
Phone
+98 71 3234 0774
Email
zahra.tab92@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information, visual motor function before and after intervention
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
Use of the data for the study and further research is permitted.
From where data/document is obtainable
Email: zahra.tab92@gmail.com
What processes are involved for a request to access data/document
Send an email to the responsible person for entering the information and explaining the reason for requesting information
Comments
It will be available through republished academic journals.