Effect of Computerized Visual Games on Handwriting, Visual Perception and Visual Motor Integration in the Children with Spastic Cerebral Palsy in the second and third grades of elementary schools.
The effect of computerized visual games on handwriting, visual perception skills and visual-motor integration in children with spastic cerebral palsy in second and third grades of elementary school.
Design
A clinical trial with a control group, parallel groups, one-strain blind, randomized, on 30 children. A www.sealedenvelope.com site will be used for randomization.
Settings and conduct
The study population is spastic cerebral palsy.
Interventions are in the field of handwriting, visual perception and motor visual integrity.
Interventions in occupational therapy clinics or exceptional schools in Tehran.
Interventions will be computeized visual games ( 20 sessions . Interventions are for individual children. Games will be played on the computer and the child will play these games with the mouse in a quiet environment).
After the end of interventions, final evaluation and then data analysis will be carried out.
The study is a blind type that will be a blind statistical analyzer. The data will be entered by the researcher and the statistical analyzer who does not know the participants will perform these analyses.)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with spastic cerebral palsy diagnosed by pediatric neuroscience
Exit Criteria: People who do not want to participate in the study at any stage of the study
Intervention groups
one of the intervention groups will receive visual perception game. The other intervention group will receive visual-motor integration play, and the third group, as the control group, will not receive any of these games.
Effect of Computerized Visual Games on Handwriting, Visual Perception and Visual Motor Integration in the Children with Spastic Cerebral Palsy in the second and third grades of elementary schools.
Public title
The Effect of Computer Vision Games on Handwriting, Visual Perception and Visual Motor Integrity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with cerebral palsy participating, second and third grade of primary school
Children diagnosed with spastic cerebral palsy by pediatric neuroscience specialty
Children in the gross movement classification system (GMFCS E&R) at levels I, II, III
Children in manual abilities classification system (MACS) at levels I, II, III
Children have the ability to write with pencil
Children with cognitive scores above 70
Children who do not achieve complete scores according to legibility criteria according to Persian Handwriting Test (PHAT)
Children who have difficulty in the Visual Perception Skills Test (TVPS-R), i.e. obtain scores below the defined average
Children who do not achieve complete scores by age in the Visual-Motor Integrity Test (DTVMI)
Exclusion criteria:
Children with modified visual acuity with glasses less than 0.7 in close vision
Children with obvious eye deviation (strabismus)
Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months
Age
From 8 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, restricted randomization method and random allocation method will be used. Children will be divided into three groups after meeting the inclusion criteria by random allocation law.
For randomization, the method of sealed envelopes will be used. After determining the sample size (30 people), 10 envelopes will be allocated to group a, and 10 envelopes will be allocated to group b ,and 10 envelopes will be allocated to group c.
Then these envelopes are moved completely to ensure that they are not in order. Then it will be placed in a container and based on the list of study participants, an envelope will be assigned to each of them, and finally it will be determined which group each participant belongs to.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that all conditions are specified in the consent form, in this study, after grouping, participants will fully understand which group they are in (for the intervention groups, computer games will be provided and no intervention will be provided for the control group) so it is not possible for the participants to blind and in this study only the data analyzers will be blind. To have the possibility of a blind side. In this study, the principal investigator will conduct preliminary assessments as well as post-intervention interventions and evaluations and is aware of the whole study process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran Medical Sciences Girls' Dormitory, north kargar. amir abad. tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.057
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
handwriting
Timepoint
Before the study and after the end of the study (the interval between pre-test and post-test will be 10 weeks)
Method of measurement
Persian Handwriting Assessment Tool (PHAT)
Secondary outcomes
1
Description
Visual-motor integrity
Timepoint
Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test)
Method of measurement
the Beery Bactenica visual Motor Integrity Development Test
2
Description
visual percetion
Timepoint
Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test)
Method of measurement
Visual Perception Skills Test TVPS-R
3
Description
Cognitive Ability
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
With Sparkle Form
4
Description
Gross Motor Function
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
Gross Movement Classification System GMFCS
5
Description
Ability of the hand
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
Manual Ability Classification System MACS
6
Description
Visual acuity
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
With the Snellen Vision Chart
Intervention groups
1
Description
The first intervention group: In this group consisting of 10 children, visual perception computer games will be presented for 20 sessions. This visual perception game is related to the skills associated with visual perception and involves steps from easy to hard. Visual Perception Games: A series of cards drawn from training books designed as games. These cards have been suggested by occupational therapists, optometrists, educators, learning specialists and other health professionals and their goal is to practice the skills of shape recognition from context, visual recognition, visual stability, visual perfection, visual sequence memory, visual-spatial relationships and visual memory in people who need to improve these skills. In this game, visual perception will be determined for the child at each session and the child will play this game on a computer belonging to the researcher and, in case of error, will receive the necessary guidance from the therapist. These games will be played for 45 minutes each. There will be 2 sessions per week, and after 10 weeks, these 20 sessions will be completed.
Category
Rehabilitation
2
Description
The second intervention group: In this group, which consists of 10 children with cerebral palsy, visual and motor computer games will be presented for 20 sessions.It is designed with German software model (Cog Pack) and consists of 9 different parts with the aim of training visual-motor integration skills. The names of these games are: Sight-Motion, UFO, Ball, Star Fall, Labyrinth, Split Boards and Cakes, Routing and Mirror, each of which has different difficulty levels. In each session, a certain number of these steps are considered. Each session will last 45 minutes. Games on the computer will be played by the child. 2 sessions per week and a total of 10 weeks of interventions will be performed.
Category
Rehabilitation
3
Description
Control group: In this group of 10 children with cerebral palsy, no intervention will be provided.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasti occupational clinic
Full name of responsible person
Mehdi Bigham
Street address
Sattar Khan. Baqer Khan Street. No. 92.
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
Haami occupational clinic
Full name of responsible person
Ghodrat khavari
Street address
Pasdaran. Daoud Eslami Street.Corner of West Gulzar
East 14th Alley, West Ferdows Blvd., Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
6
Recruitment center
Name of recruitment center
Haji Babaei Exceptional School
Full name of responsible person
mr mahmoodi
Street address
kazane St Yari Street
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
7
Recruitment center
Name of recruitment center
Imam Reza Exceptional School
Full name of responsible person
mrs. abbasi
Street address
Yakhji Abad Neighborhood - Rezvan, Tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran. Amir Abad St. North Kargar Street. Tehran Medical Sciences Girls' Dormitory
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.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
1
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
Aida Kazemnazhand Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Girls' Dormitory of Tehran University of Medical Sciences, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Province
Tehran
Postal code
5539955975
Phone
+98 21 8670 5503
Email
a-kazemnazhand@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Kazemnazhand Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Girls' Dormitory of Tehran University of Medical Sciences, Noth Kargar Ave, Amir Abad, Teharn city
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8670 5503
Email
a-kazemnazhand@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Kazemnazhand Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Girls' Dormitory of Tehran University of Medical Sciences, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8670 5503
Email
a-kazemnazhand@razi.tums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the study is completed, this data can be published in the form of a spss, if the judges or researchers ask our study group.
When the data will become available and for how long
We will probably be able to access this data up to a year after the results are published.
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
To investigate the relationship between variables
From where data/document is obtainable
Researcher of this study: Aida Kazemnazhand Asl. by email: a-kazemnazhand@razi.tums.ac.ir
What processes are involved for a request to access data/document
First, email a message to the researcher about the purpose of using the data, along with enough information from the name and address of the researcher. In case of checking the cases and making sure of the maral, it will be sent in a short period of time.