NCT07723092

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2026

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 20, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

School-Based Occupational TherapyTask-Focused Occupational TherapyHandwritingFine Motor SkillsVisual-Motor IntegrationAcademic PerformancePrimary School Children

Outcome Measures

Primary Outcomes (1)

  • Change in Handwriting Performance Assessed by the Minnesota Handwriting Test

    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 Outcomes (3)

  • Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test

    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

    Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)

  • Change in Academic Performance

    Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)

Other Outcomes (1)

  • Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling

    Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)

Study Arms (2)

Structured Task-Focused Occupational Therapy

EXPERIMENTAL

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.

Behavioral: Structured Task-Focused Occupational Therapy Program

Routine Classroom Activities

NO INTERVENTION

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.

Interventions

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.

Structured Task-Focused Occupational Therapy

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Güngören Yahya Çavuş Primary School

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Occupational Therapy, Istanbul Medipol University

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

July 27, 2026

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

October 12, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations