This study examines the effects of fine motor learning and changes in the motor, linguistic and cognitive systems of children with mental disabilities.
Design
Randomized Clinical trials, Double-blind, Random and hidden
Settings and conduct
This study will be conducted at Najaf Abad Mehr Rehabilitation Center in Isfahan. Children will be divided into intervention and control groups.
Health workers (therapist, speech therapist, and psychologist) who evaluate the initial and final evaluation will also not be aware of the allocation of any children in the groups and will be required to accurately assess all the children participating (case and control) and The final allocation of these children will be done by the trainer. After the end of the interventions, the initial and final information of both groups will be collected by the educational instructor and the statistics expert will be presented for analysis and comparison of the results of the two groups.
Participants/Inclusion and exclusion criteria
The child is a Persian language and speaks only in Persian at home.
The language age of the child is at the stage of the emerging or progress of the language.
The child is a person with educable intellectual disabilities on the basis of an IQ of 50 to 70.
Intervention groups
In this study, children will be divided into intervention and control groups, which will receive the routine care center of the center as usual and in the intervention group, in addition to rehabilitation services, will receive special training in subtle motor skills based on the HOMA educational protocol and In the end, the results of the evaluations will be compared between the two groups.
Main outcome variables
Language skills, Gross and fine motor skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190309042983N1
Registration date:2019-04-30, 1398/02/10
Registration timing:registered_while_recruiting
Last update:2019-04-30, 1398/02/10
Update count:0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Ehsan Hemmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 3434
Email address
hemmati.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Fine Motor Training on Language and Motor Skills in Children with Intellectual Disabilities
Public title
The effect of Fine Motor Training on linguistic and motor skills
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child is a person with educable intellectual disabilities on the basis of an IQ of 50 to 70, and the Vineland Social Maturity Scale.
The language age of the child is at the stage of the emerging or progress of the language, which is determined by the form of the PANA profile.
The child is a Persian language and speaks only in Persian at home, which is based on the Persian language of the child's question of parents.
The child's parents have literacy skills that can read and respond to checklist, which is obtained through parenting questions.
According to a parent's report, the child has no hearing impairment.
According to the parents of children who are blind or severely visually impaired is not.
Exclusion criteria:
If the examinations (pre-test or post-test) occupational therapy, speech therapy or psychology for children has not been done.
The child's parents did not respond to more than half of the checklists questions.
The child has autism diagnosis, which, if suspected, is evaluated by a psychiatrist.
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, case and control groups will be randomized through the stratified randomization so that in addition to the same sample size, variables such as IQ, linguistic and motor skills should be the same in the two groups. The results and final differences between the two groups can be understood as the effect of interventions in the case group. After applying these layers, homogeneous individuals in each layer will be randomly assigned to one of the case and control groups based on random numbers.
Hiding in this study will be done by an instructor. Speech therapist, occupational therapist, psychologist and even parents of these children will be unaware of being or not taking each child in the case and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: From the parents, all participants (both case and control groups) received written consent for participation in the study, but consent will be made that the participating children will be randomly divided into two groups and only one intervention group, mean your baby will have 50 percent chance of receiving an intervention.
The main researcher (Ehsan Hemmati) is not involved in sampling, and his colleague will conduct linguistic assessments. Health workers (therapist, speech therapist, and psychologist) who evaluate the initial and final evaluation will also not be aware of the allocation of any children in the groups and will be required to accurately assess all the children participating (case and control) and The final allocation of these children will be done by the trainer. After the end of the interventions, the initial and final information of both groups was collected by the educational instructor and the statistics expert will be presented for analysis and comparison of the results of the two groups (without specifying the case group from the control).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University Medical Sciences, Hemmat freeway, next to Milad tower, Tehran
City
Tehran
Province
Tehran
Postal code
1135617713
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.IUMS.REC.1397.1163
Health conditions studied
1
Description of health condition studied
Intellectual Disabilities
ICD-10 code
F70
ICD-10 code description
Mild intellectual disabilities
Primary outcomes
1
Description
the language skills and gross and fine motor skills
Timepoint
At the beginning of the study and the end of the intervention
Method of measurement
Through questionnaires, checklists and record sample and speech analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the educational protocol of drawing (Homa design) as an intervention for fine motor training to the children of the intervention group is used. This protocol, which is designed to measure the ability of visual arts for people with special needs, determines the ability to draw these children. In this intervention, each child is trained individually, two sessions per week for six months. This intervention has been designed in five main attributes, including understanding the shape, understanding positioning, understanding the size, drawing power and the precision in drawing that is necessary for painting, which is arranged in 15 columns and in a single page. To run this test, the instructor will ask the child to draw the same box as the test form in the blank box of the same page and then score the child according to the scoring criterion. According to the score, the child will be placed in one of the six levels of the test, and according to his level, he will start specific training. The A level test is all about Blatter, and the person is able to draw complicated subjects with fit and perfect composition. Level B includes intricate topics with low detail, C level, simple threads with wide color surfaces with distinct and large detail, D level, simple threads with wide color surfaces with distinct, large and small detail, E Simple threads with wide color surfaces with distinct layouts, without the details, and level F, include lines, dots, and sprays of simple colors and incomplete levels. In this plan, sub-classes B to F is assigned classed exercises to obtain the ability to perform exercises. These exercises include point-related, line-related, color-related, and related-level exercises.
Category
Rehabilitation
2
Description
Control group: Routine care=
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr rehabilitation center
Full name of responsible person
Alireza Aghaz
Street address
No. 31, Mehran Ave., Ghods St., Najaf Abad Town.
City
Najaf Abad
Province
Isfehan
Postal code
8514868414
Phone
+98 31 4274 7402
Email
Aghaz93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ehsan Hemmati
Street address
No. 13, 30tir Ave., Hafez Blvd
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 51 3881 3434
Email
hemmati.e@iums.ac.ir
Grant name
Grant code / Reference number
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
Ehsan Hemmati
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
No. 13, 30tir Ave., Hafez Blvd
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 51 3881 3434
Fax
Email
hemmati.e@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad-Taghi Joghataei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran university of medical sciences, Hemmat Blvd.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
joghataei@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ehsan Hemmati
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
NO, 13, 30tir Ave, Hafez Street
City
Tehran
Province
Tehran
Postal code
1135617713
Phone
+98 21 3881 3434
Email
hemmati.e@iums.ac.ir
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
Not applicable
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