The comparison of the effectiveness of sensory-motor integration and cognitive rehabilitation on executive functions (attention, working memory and inhibition), fine motor skills, and reading of slow learner students
Determining effectiveness of sensory-motor integration and cognitive rehabilitation on executive functions, fine motor skills and reading of slow learner students
Design
A clinical trial with a controlled group & 2 experimental groups, single-blind, randomized, Phase 3, conducted on 15 slow learner students for each group. Using SPSS software for analysis
Settings and conduct
After determining the samples and placing them in two intervention groups and a control group, 14 individual sessions are conducted for each member of each intervention group at the Rezvan Center for Students with Special Learning Disabilities (the researcher's workplace) in Sari. Given the random placement of the samples in each group, members of each group are only provided with information related to the rehabilitation method related to their group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Attendance at primary school except first grade, having a slow learning intelligence
Exclusion criteria: Having a comorbid disorder, concurrent rehabilitation
Intervention groups
The samples are randomly placed into 3 groups (two experimental groups and one control group) and the relevant rehabilitation training packages are given to each member of the three groups over 14 sessions.
Main outcome variables
Improving the quality of life of slow learner students and their families; Developing effective education programs for slow learner students in schools and centers for Specific Learning Disabilities; Preventing long-term social and behavioral problems of slow learner students; Strengthening and facilitating relationships between students and peers and educational staff with slow learner students in schools
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250306064948N1
Registration date:2025-05-06, 1404/02/16
Registration timing:prospective
Last update:2025-05-06, 1404/02/16
Update count:0
Registration date
2025-05-06, 1404/02/16
Registrant information
Name
MARYAM FAZELMASAELI
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Country
Iran (Islamic Republic of)
Phone
+98 11 3370 1579
Email address
maryamfazelmasaeli@au.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-21, 1404/02/31
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of sensory-motor integration and cognitive rehabilitation on executive functions (attention, working memory and inhibition), fine motor skills, and reading of slow learner students
Public title
The comparison of the effectiveness of sensory-motor integration and cognitive rehabilitation on slow learner students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Attendance in primary education except for the first grade
Having a borderline intellectual functioning
Exclusion criteria:
Having potential comorbid disorders
Receiving simultaneous rehabilitation
Age
From 8 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population includes all borderline intellectual functioning students in Sari. The sampling method is purposive; the sample consists of elementary school students (except for first grade) in the 2024–2025 academic year in Sari. These students may have a record in the SANAD system, a school referral letter, or may have visited the city's Special Learning Disability Centers at their parents' request. From this group, 45 students will be selected using a purposive sampling method. After administering specialized tests, they will be randomly assigned to three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the placement of participants in each of the three groups is random, only the rehabilitation method used in each group will be explained.
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 – Ahvaz Branch
Street address
Faculty of Nursing and Midwifery, Ahvaz Branch, Islamic Azad University, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Approval date
2025-01-03, 1403/10/14
Ethics committee reference number
IR.IAU.AHVAZ.REC.1403.377
Health conditions studied
1
Description of health condition studied
Weaknesses in Executive Functions (Attention, Working Memory, Inhibition) of Slow Learner Students, Weaknesses in Fine Motor Skills of Slow Learner Students, Weaknesses in Reading Skills of Slow Learner Students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Executive Functions (attention, working memory ,inhibition) of slow learner students
Timepoint
Measuring Executive Functions (Attention, Working Memory, Inhibition) of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups
Method of measurement
Measurement of Executive Functions (Attention with the Stroop Test, Working Memory with the WMTB-C Test, Inhibition with the Go-No Go Test)
2
Description
Fine motor skills of slow learner students
Timepoint
Measuring Fine Motor Skills of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups
Method of measurement
Measurement of Fine Motor Skills with the Bruininks-Oseretsky Test
3
Description
Reading of slow learner students
Timepoint
Measuring Reading of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups
Method of measurement
Measurement of Reading Skills with the Nema Reading Test.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group with Sensory- Motor Integration Method: 15 eligible subjects were randomly assigned to this group and provided with a sensory - motor integration training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions.
Category
Rehabilitation
2
Description
The second intervention group with Cognitive Rehabilitation Method: 15 eligible subjects were randomly assigned to this group and provided with a cognitive rehabilitation training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions.
Category
Rehabilitation
3
Description
Control group: without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rezvan Center for Students with Specific Learning Disabilities
Full name of responsible person
Maryam Fazel Masaeli
Street address
Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway
City
Sari
Province
Mazandaran
Postal code
4816964434
Phone
+98 11 3321 6156
Email
maryamfm49@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University- Ahvaz Branch
Full name of responsible person
Marzieh Talebzadeh Shoushtari
Street address
Ahvaz Branch, Islamic Azad University, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Phone
+98 916 619 4772
Email
talebzadehmarzieh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University- Ahvaz Branch
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
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Maryam Fazel Masaeli
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway
City
Sari
Province
Mazandaran
Postal code
4816964434
Phone
+98 11 3321 6156
Email
Maryamfm49@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Maryam Fazel Masaeli
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway
City
Sari
Province
Mazandaran
Postal code
4816964434
Phone
+98 11 3321 6156
Email
Maryamfm49@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Maryam Fazel Masaeli
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway
City
Sari
Province
Mazandaran
Postal code
4816964434
Phone
+98 11 3321 6156
Email
Maryamfm49@gmail.com
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
All data is potentially shareable after anonymizing individuals
When the data will become available and for how long
The access period begins 6 months after the publication of the results
To whom data/document is available
All researchers working in academic and scientific institutions, specialists in psychology with fields related to the research topic, students, and researchers in this area
Under which criteria data/document could be used
The results and data of the research will be presented to improve the living and educational conditions of slow learner students
From where data/document is obtainable
Specialized websites, reputable related journals, and the researcher's email address
What processes are involved for a request to access data/document
After the completion of the research, final presentation of the results, and defense, the information will be published and, depending on the time required for publication, it will be accessible from related credible sources