The Effect of Cognitive Orientation to daily Occupational Performance (CO-OP) Approach in improving handwriting performance of children with specific learning disorder 8-12 years old
Determining the effectiveness of the cognitive orientation to daily occupational performance approach (CO-OP) in the handwriting of children with specific learning disabilities aged 8 to 12 years, such as dyslexia and dysgraphia
Design
Randomised, parallel group trial design of 15 samples in each group with blinded outcome assessment. Random allocation was centralised and computerised with block randomization with both boys and girls in each group.
Settings and conduct
The intervention in both groups is carried out in ten sessions by a common therapist in 40 minutes, and for checking the results of the interventions, an evaluator who is blind to the people in the groups and the process of the interventions evaluates the results.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with specific learning disabilities such as dyslexia and dysgraphia
8-12 years old
Children who have been diagnosed with a learning disorder based on the patient's profile by a psychiatrist and those who study in schools or learning disorder centers.
Do not have visual and auditory processing problems
Do not have another medical diagnosis such as autism spectrum disorder
Exclusion criteria:
If the participants have already received the co-op approach
If the family or the child does not want to collaborate for any reason.
Intervention groups
In the intervention group, CO-OP is implemented, and the control group receives typical interventions in occupational therapy (perceptual-motor interventions most used by occupational therapists in studies are visual-motor integration (VMI) interventions).
Main outcome variables
Legibility in dictation and copy; speed in copy; occupational performance; executive functions; reading skills
General information
Reason for update
Acronym
CO-OP
IRCT registration information
IRCT registration number:IRCT20240822062837N1
Registration date:2024-09-05, 1403/06/15
Registration timing:prospective
Last update:2024-09-05, 1403/06/15
Update count:0
Registration date
2024-09-05, 1403/06/15
Registrant information
Name
Sara Zamiran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 520 1519
Email address
sarazamiran@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Orientation to daily Occupational Performance (CO-OP) Approach in improving handwriting performance of children with specific learning disorder 8-12 years old
Public title
The Effect of Cognitive Orientation to daily Occupational Performance (CO-OP) Approach in improving handwriting performance of children with specific learning disorder 8-12 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with specific learning disabilities such as dyslexia and dysgraphia
8-12 years old
Children who have been diagnosed with a learning disorder based on the patient's profile by a psychiatrist and those who study in schools or learning disorder centers.
Do not have visual and auditory processing problems
Do not have another medical diagnosis such as autism spectrum disorder.
Exclusion criteria:
If the participants have already received the co-op approach
If the family or the child does not want to collaborate for any reason.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating the samples to the control and intervention groups is by random allocation and using the block randomization method, in which there are boys and girls in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, both intervention and control groups have a common therapist who is aware of the intervention process, and both groups have a common evaluator who is blind to the process of the intervention and the people in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2024-08-18, 1403/05/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.201
Health conditions studied
1
Description of health condition studied
Specific learning disorder
ICD-10 code
F81
ICD-10 code description
Specific developmental disorders of scholastic skills
Primary outcomes
1
Description
Legibility in dictation and copy; speed in copy; occupational performance;
Timepoint
The beginning and the end of the intervention
Method of measurement
Legibility and speed is measured by "Persian Handwriting Assessment Tool"; occupational performance is measured by "Canadian Model of Occupational Performance" and "Performance Quality Rating Scale".
Secondary outcomes
1
Description
Executive functions; reading skill
Timepoint
The beginning and the end of the intervention.
Method of measurement
executive functions is measured by "Behavioral rating inventory of executive function". reading skill is measured by "KHANA".
Intervention groups
1
Description
Intervention group: The intervention group will receive the Co-op cognitive approach for 10 sessions of 40 minutes. These sessions are held once a week and last for 10 weeks. between sessions, students get homeworks to do till the next session.
Category
Rehabilitation
2
Description
Control group: The selected intervention for the control group is a perceptual-motor approach called visual-motor integration. This intervention is implemented according to the established protocol of 10 sessions of 40 minutes and continues for 10 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
SBMU School of Rehabilitation Sciences
Full name of responsible person
Sara zamiran
Street address
SBMU School of Rehabilitation Sciences, across from Buali hospital, Damavand street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
saraazamiran@gmail.om
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zerghi
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Zamiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, across from Buali hospital, Damavand street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 918 520 1519
Fax
Email
sarazamiran@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Zamiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, across from Buali hospital, Damavand street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 918 520 1519
Fax
Email
sarazamiran@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Zamiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, across from Buali hospital, Damavand street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 918 520 1519
Fax
Email
sarazamiran@sbmu.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
Data about primary and secondary outcome measures; statical analysis of outcomes and the study protocol
When the data will become available and for how long
Available after publishing the results
To whom data/document is available
Researchers and therapists
Under which criteria data/document could be used
Using the study protocol for use in the clinic as a new approach and other similar researches
From where data/document is obtainable
First author: saraazamiran@gmail.com
What processes are involved for a request to access data/document
The information will be available by the first author or the corresponding author within one week after sending the email.