the aim of the present research was to analyze the effect of eye exercises with and without active movements on motor skills in children with amblyopia.
Design
A randomized controlled clinical trial, 4 Amblyopia children with parallel groups, randomized, Triple blind
Settings and conduct
At first, general descriptions of the type of interventions were given to the subjects and their parents, and the parents of the children signed informed consent to participate in the study. Then, all subjects in the four groups received visual perception and motor skills as pre-test. Each of the experimental groups underwent individually designed 30-minute sessions of individually designed 3-minute sessions for four weeks. The control group subjects performed their daily activities and did not perform any specific exercise. All subjects took post-test two days after the last training session. It should be noted that the intervention, pre-test and post-test groups were trained in a part of a gym equipped for this purpose. Subjects did not know the interventions group exercises and that the subjects in the four groups had no knowledge of the type of exercises and how to perform them in other groups; the principal investigator selected one Individual examiners and practitioners were blinded to each group and data analyst by providing statistical corrections through predefined codes.
Participants/Inclusion and exclusion criteria
A group of 40 children aged 5-8 years with amblyopia
Intervention groups
Three groups: eye exercises without active movements, eye exercises with active movements (ocular, ocular and manual, and displacement), and control(They did their daily activities and did not do any of the interventions).
Main outcome variables
motor skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045425N1
Registration date:2019-12-27, 1398/10/06
Registration timing:retrospective
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Mohammad Reza Shahabi Kaseb
Name of organization / entity
Hakim sabzevari university
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 4160
Email address
mr.shahabi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-12-31, 1396/10/10
Actual recruitment end date
2018-01-30, 1396/11/10
Trial completion date
2018-01-30, 1396/11/10
Scientific title
The effect of eye exercises with and without active movements on motor skills in children with amblyopia
Public title
The effect of eye exercises on children with amblyopia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with amblyopia (caused by refractive errors)
Exclusion criteria:
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned to one of four groups by simple random method (ball and bowl). The groups were randomly assigned to experimental and control groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
Attendees at different times to intervene
Supplementary Description: Before the subjects were included in the study, a general introduction to the research objectives for the subject and their parents was made. So they knew the whole point. Subjects were present at the training site at different times to observe the “independence of observations”.
Using an evaluator that was not part of the research group
Use statistics expert
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Sabzevar
Before the intervention and two days after the last training session (after the intervention)
Method of measurement
Lincoln Oseretsky's test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First. Exercise-Free Vision Training Group (Exercise Vision-Free Bodybuilding). The subjects in this group sat in a stationary and immobilized position and performed dynamic sharpening exercises, field-based perception, depth-perception, and eye-tracking using movement only. The eyes did. Subjects performed three 30-minute sessions of exercise for four weeks each week.
Category
Prevention
2
Description
Intervention group: Second. The group with active low vision exercises consisted of hands-on visual exercises (visual-manual exercises). Field perception, depth perception, and visual pursuit were performed with hand movement. Subjects performed three 30-minute sessions of exercise for four weeks each week.
Category
Prevention
3
Description
Intervention group: Third. High-intensity, active-motion visual exercises that included whole-body visual training (visual-movement exercises). Subjects performed visual-displacement exercises, dynamic sharpening exercises, field form perception, depth perception, and visual pursuit along with whole-body displacement. Subjects performed three 30-minute sessions of exercise for four weeks each week.
Category
Prevention
4
Description
Control group: The control group subjects did their daily activities and did not perform any extra exercises. Only participated in pre-test and post-test
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بهزیستی
Full name of responsible person
Marziee Kasraee far
Street address
Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 4160
Email
mr.shahabi@hsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Sabzevar University
Full name of responsible person
Ahmad Farzaneh Kord
Street address
Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2762
Email
mr.shahabi@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevar 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
Hakim Sabzevari University
Full name of responsible person
Mohammad Reza Shahabi Kaseb
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Behavior
Street address
Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 4160
Email
mr.shahabi@hsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hakim Sabzevar University
Full name of responsible person
Mohammad Reza Shahabi Kaseb
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Behavior
Street address
Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 4160
Email
mr.shahabi@hsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hakim Sabzevar University
Full name of responsible person
Mohammad Reza Sahabi Kaseb
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi
City
Sbzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 4160
Email
mr.shahabi@hsu.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
Motor skills scores can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
participants
Under which criteria data/document could be used
Data and documentation are available for use in welfare centers.
From where data/document is obtainable
Apply to mr.shahabi@hsu.ac.ir
What processes are involved for a request to access data/document
Results will be announced a week after the application is submitted