Investigating the efficacy of mixed training regimen of verbal working memory and visuo-motor activity on verbal working memory, postural control and reading skills in persian dyslexic children, aged 6 to 12 years
Investigating the efficacy of mixed training regimen of verbal working memory and visuo-motor activity on verbal working memory, postural control and reading skills in persian dyslexic children, aged 6 to 12 years.
Design
A Comparative double-blind clinical trial (phase-II) with experiment and control groups.also, the assessments will be done before and after treatment
Pre-test→ Treatment: 4w,3d/w,30-45 min/d→ Post-test
Settings and conduct
This is the first study applying the mixed training regimen of VWM and visuo-motor activity in dyslexic children, aged 6 to 12 years old. Participants will be recruited from governmental primary schools and rehabilitation centers. They will be divided into tow groups as intervention and control. participants and data analyzer will be blinded as double-blinded study. After pre-treatment assessment and treatment (4 w, 3 d/w, 30-45 min/d) we will do the post-treatment assessments.
Participants/Inclusion and exclusion criteria
Dyslexic children; 6-12 years old; Native farsi language- unilingual; Multi-centers in Tehran city; Moderate socioeconomic level; Right-handed; Normal or corrected visual ability; Normal hearing ability; No history of head injuries and symptoms of brain damage; No history of psychiatric disorders; Full- IQ scores above 85; Without ADHD; Do not use drugs that may affect attention
Intervention groups
ٍSubjects in experiment group will receive the mixed training regimen of verbal working memory and visuo-motor activity. also, subjects in control groups will receive the training regimen of verbal working memory.
Main outcome variables
ْThe function of VWM; the function of postural control; the function of word reading; the function of wordchain; the function of rhyming; the function of text comprehension; the function of phoneme deletion; the function of non-word reading; the function of semantic categories; the full IQ score; ADHD; age; study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037953N1
Registration date:2018-02-08, 1396/11/19
Registration timing:prospective
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Mehdi Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 1194
Email address
ergotherapist.ramezani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of mixed training regimen of verbal working memory and visuo-motor activity on verbal working memory, postural control and reading skills in persian dyslexic children, aged 6 to 12 years
Public title
Investigating the efficacy of mixed training regimen of verbal working memory in dyslexic children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing dyslexia by WISC IV
Aged 6-12 y
Students of Schools in Tehran and the moderate socioeconomic status
Right-handed
Normal or corrected to normal visual acuity
Normal hearing status
No history of head injury
No history of psychiatric disorders
Full IQ score greater than 85
Without co morbidity with ADHD
Persian monolingual
Do not using of druges affect on attention
Exclusion criteria:
Not attending in pretest assessment and training sessions
Participation in training sessions Less than 75% of all sessions/ less than 9 sessions out of 12 sessions
Not attending in post-test assessment sessions
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the available samples based on the inclusion criteria, Individuals are randomly (coin throwing method) divided into two groups, experiment (EG) and active control (CG).
Head of the coin, EG (10-20).
Tail of the coin, CG (10-20).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded study, blinding will be applied to all participants and outcome assessment.
Blinding of participants is possible. They will not know in which group they have been placed. Although, parent will know in which group their child has been placed. After finishing the treatment period, the data will be analyzed by a blinded statistician who will receive coded data. He/she will not know who is participating in which group.
Placebo
Not used
Assignment
Parallel
Other design features
Training regimen will be done by self-manufactured trainer robot for 4 weeks, 3 times a week, 30 to 45 minutes in every sessions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC 1396.31977
Health conditions studied
1
Description of health condition studied
Developmental dyslexia or specific reading disorder
ICD-10 code
F81.0
ICD-10 code description
Specific reading disorder
Primary outcomes
1
Description
Verbal working memory
Timepoint
Before and after treatment, 4-5 weeks.
Method of measurement
Forward and backward digit span
Secondary outcomes
1
Description
Postural control
Timepoint
Before and after treatment-4 to 5 weeks
Method of measurement
Cop data of force platform tool
2
Description
Reading Skills
Timepoint
Before and after treatment-4 to 5 weeks
Method of measurement
Scores of reading skills native battery sub tests
3
Description
Changes in functional connectivity of VI and Crus I lobules of the cerebellum
Timepoint
Before and after treatment-4 to 5 weeks
Method of measurement
Resting-state fMRI
Intervention groups
1
Description
Intervention group: participants in this group will receive the mixed training regimen of verbal working memory and visual-motor activity: presenting the word; decomposition of the word to it’s letters/ moving of the platform; repetition of the previous step by Active movements of the child; retrieving the letters of the word.
Category
Treatment - Devices
2
Description
Control group: participants in this group will receive the training of verbal working memory: presenting the word; decomposition of the word to it’s letters; retrieving the letters of the word.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Governmental primary schools
Full name of responsible person
Government
Street address
Unknown
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.ac.ir
2
Recruitment center
Name of recruitment center
Rehabilitation centers
Full name of responsible person
Unknown
Street address
Unknown
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Malakouti
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14665354
Phone
+98 21 81631
Fax
+98 21 81631
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.ac.ir
Grant name
no
Grant code / Reference number
خیر
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehdi Ramezani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14665354
Phone
+98 21 81631
Fax
+98 21 81631
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Ramezani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14665354
Phone
+98 21 3340 1194
Fax
+98 21 3340 1194
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Ramezani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14665354
Phone
+98 21 81631
Fax
+98 21 81631
Email
ergotherapist.ramezani@gmail.com
Web page address
https://www.iums.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
age
score of full IQ
sex
scores of verbal working memory
scores of postural control parameters
changes of functional connectivity
scores of reading subtests
When the data will become available and for how long
6 month after publication of papers
To whom data/document is available
active researchers
Under which criteria data/document could be used
scientific using
From where data/document is obtainable
electronic post address
What processes are involved for a request to access data/document