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- Klinische proef NCT07723092
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
23 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Istanbul
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Istanbul, Istanbul, Turkije (Türkiye)
- Güngören Yahya Çavuş Primary School
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Contact:
- Merve Keskin, MSc
- Telefoonnummer: +90 5375825256
- E-mail: mervekeskiin98@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Geen tussenkomst: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Handwriting Performance Assessed by the Minnesota Handwriting Test
Tijdsspanne: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test
Tijdsspanne: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Change in Visual-Motor Performance Assessed by the Beery VMI
Tijdsspanne: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Change in Academic Performance
Tijdsspanne: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling
Tijdsspanne: Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
27 juli 2026
Primaire voltooiing (Geschat)
12 oktober 2026
Studie voltooiing (Geschat)
12 oktober 2026
Studieregistratiedata
Eerst ingediend
20 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 juli 2026
Eerst geplaatst (Werkelijk)
23 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
23 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- IMU-OT-STFOT-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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