- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723092
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
July 23, 2026 updated by: Merve Keskin, Medipol University
This randomized controlled trial will evaluate the effects of a structured, task-focused occupational therapy program delivered in the school environment on handwriting performance, fine motor skills, visual-motor integration, and academic performance in primary school children.
Second- and third-grade students identified as being at risk for handwriting and manual dexterity difficulties will be randomly assigned to an intervention group or a control group.
The intervention group will receive a 10-week school-based occupational therapy program consisting of two 30-minute sessions per week, for a total of 20 sessions.
The control group will continue routine classroom activities without therapist-led occupational therapy.
Handwriting, manual dexterity, visual-motor integration, visual perception, and motor coordination will be assessed at baseline and after the intervention.
Academic grades will also be recorded, and individualized goal attainment will be evaluated in the intervention group.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- Güngören Yahya Çavuş Primary School
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Contact:
- Merve Keskin, MSc
- Phone Number: +90 5375825256
- Email: mervekeskiin98@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between 7 and 9 years of age
- Being enrolled in the second or third grade
- Demonstrating basic literacy skills
- Being identified as high risk for handwriting and/or manual dexterity difficulties based on standardized assessments and teacher observations
- Being expected to maintain regular school attendance throughout the study period
- Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- A diagnosed neurodevelopmental disorder, including autism spectrum disorder or attention-deficit/hyperactivity disorder
- Significant visual or hearing impairment
- An orthopedic or neurological condition affecting the upper extremity
- Current receipt of occupational therapy or special education services
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Task-Focused Occupational Therapy
Participants will receive a 10-week structured task-focused school-based occupational therapy program delivered twice weekly in 30-minute sessions, for a total of 20 sessions.
The program will target handwriting performance, fine motor skills, visual-motor integration, visual perception, and motor coordination.
|
The intervention consists of a 10-week structured task-focused occupational therapy program delivered in the school environment.
Participants will receive two 30-minute sessions per week, for a total of 20 sessions.
The program will include task-oriented activities targeting handwriting performance, fine motor skills, manual dexterity, visual-motor integration, visual perception, and motor coordination.
|
|
No Intervention: Routine Classroom Activities
Participants will continue their routine classroom activities and teacher-assigned homework during the 10-week study period and will not receive therapist-led occupational therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Handwriting Performance Assessed by the Minnesota Handwriting Test
Time Frame: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Handwriting performance will be assessed using the Turkish version of the Minnesota Handwriting Test (MHT).
The test includes 34 letters arranged in seven words and evaluates handwriting completion time, legibility, form, alignment, spacing, and size.
Completion time is recorded in seconds, with shorter times indicating faster performance.
Quality parameters are scored up to 34 points, with higher scores indicating better handwriting quality.
Change from baseline to post-intervention will be compared between the intervention and control groups.
|
Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test
Time Frame: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Manual dexterity will be assessed using the Minnesota Manual Dexterity Test (MMDT).
Completion times for the placing and turning tasks will be recorded in seconds.
Shorter completion times indicate better manual dexterity.
|
Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
|
Change in Visual-Motor Performance Assessed by the Beery VMI
Time Frame: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Visual-motor performance will be assessed using the Beery-Buktenica Developmental Test of Visual-Motor Integration.
Outcomes will include the Visual-Motor Integration total score, Visual Perception subtest score, and Motor Coordination subtest score.
Scores will be interpreted according to age-based normative values, with higher scores indicating better performance.
|
Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
|
Change in Academic Performance
Time Frame: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Academic performance will be evaluated using official school grades in Turkish Language, Mathematics, and Life Sciences.
Grades range from 1 to 4, with higher grades indicating better academic performance.
|
Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling
Time Frame: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Goal Attainment Scaling will be administered only to participants in the intervention group.
Individualized SMART goals will be rated on a five-point scale ranging from -2 to +2, where -2 represents performance much lower than expected, 0 represents the expected level of achievement, and +2 represents performance much higher than expected.
Higher scores indicate greater goal attainment.
|
Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 27, 2026
Primary Completion (Estimated)
October 12, 2026
Study Completion (Estimated)
October 12, 2026
Study Registration Dates
First Submitted
July 20, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 23, 2026
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IMU-OT-STFOT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.