Protocol summary

Study aim
Study the effect of online visual games on balance, visual perception, and oculomotor skills of children with developmental dyslexia during Covid -19 pandemic
Design
The interventions will be designed and made by Niloufar Chamani (Master of Sciences student in Occupational Therapy) as computer games and, will be provided to the intervention group online.
Settings and conduct
All assessments will be performed at Tehran University of Medical Sciences, Faculty of Rehabilitation, and as much as possible in the same conditions and environment for all participants. Interventions will be provided to the intervention group as web-based online computer games at home and, no intervention will be done in the control group. Blinding will be done only for the people who are in charge of evaluation and these people are not informed about the grouping of participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: developmental dyslexia diagnosis, NEMA scores below average, having normal IQ (equal to or above 85), age between 7 to 11 years (first-grade child should be at least In the second quarter of the academic year), and being fluent in Persian. Exclusion criteria: any neurological disorders, attention deficit hyperactivity disorder, or sensory visual impairment
Intervention groups
This study includes two groups: intervention and control. Online computer games will provide to the intervention group for one month and, the control group will not receive any intervention in this study.
Main outcome variables
Creating a product to improve visual skills, may easily be available to these children as an effective treatment, would be applicable as an available method to help treat these children as quickly and easily as possible, The findings of this study can be used for other related studies in the future.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210925052568N1
Registration date: 2021-11-16, 1400/08/25
Registration timing: registered_while_recruiting

Last update: 2021-11-16, 1400/08/25
Update count: 0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Niloufar Chamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 4030
Email address
nchamani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2021-12-01, 1400/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of online visual games on balance, visual perception, and oculomotor skills of children with developmental dyslexia during Covid -19 pandemic
Public title
Study the effect of online visual games on balance, visual perception and, oculomotor skills of children with developmental dyslexia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of Developmental dyslexia NEMA scores are lower than average Have a normal IQ (equal to or above 85) Age between 7 and 11 years (first grader must be at least in the second quarter of the school year) Fluency in Persian
Exclusion criteria:
Existence of any neurological disorder, attention deficit hyperactivity disorder or visual sensory impairment
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is the random allocation rule. This method represents a large block for the total sample size, which is 50 people, which randomly assigns 25 children with developmental dyslexia (DD) in the intervention group and the rest of the children with DD are in the control group. The number is assigned and the numbers are written on paper and packaged in exactly the same way. These numbers are placed in a container and then the numbers are randomly removed from the container without replacement and the created sequence is recorded. The first 25 children are in the intervention group and the rest are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluators including a psychologist, an occupational therapist, and an audiologist. They perform all assessments, including TVPS-R, PBS, VNG, Wechsler Child Scale (WISC-IV), and reading and dyslexia (NMA) tests. Evaluators will not be aware of whether individuals are in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of school of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Unit 2, no 3, Haghighat alley, Aram st, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515759966
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.TUMS.FNM.REC.1400.142

Health conditions studied

1

Description of health condition studied
developmental dyslexia
ICD-10 code
R48.0
ICD-10 code description
Dyslexia and alexia

Primary outcomes

1

Description
visual perception skills
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Test of Visual Perception Skills-Revised

2

Description
oculomotor skills
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Videonystagmography

3

Description
postural balance skills
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Pediatric Balance Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The interventions will be performed in 15 sessions on a daily basis for a month and for 30 minutes a day. The interventions will be designed and made by Niloufar Chamani (Master student of Occupational Therapy) in the form of computer games and will be provided to the intervention group in the form of online computer games for one month. Computer games will be designed and made using visual perception training cards and eye movement exercises.
Category
Rehabilitation

2

Description
Control group: Does not receive any intervention in this study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Niloufar Chamani
Street address
Corner of Safialishah, pich -e- Shemiran, Enghelab AV.
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 6586
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmadreza Khatoonabadi
Street address
Corner of Safialishah, pich -e- Shemiran, Enghelab AV.
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
khatoonabadi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Niloufar Chamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 2, no 3, Haghighat alley, Aram st, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515759966
Phone
+98 81 3822 4030
Email
n.chamani72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niloufar Chamani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 2, no 3, Haghighat alley, Aram st, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515759966
Phone
+98 81 3822 4030
Email
n.chamani72@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niloufar Chamani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 2, no 3, Haghighat alley, Aram st, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515759966
Phone
+98 81 3822 4030
Email
n.chamani72@gmail.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
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
Loading...