- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07723092
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
23. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye)
- Güngören Yahya Çavuş Primary School
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Kontakt:
- Merve Keskin, MSc
- Telefonnummer: +90 5375825256
- E-mail: mervekeskiin98@gmail.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
|
Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Handwriting Performance Assessed by the Minnesota Handwriting Test
Tidsramme: 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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
27. juli 2026
Primær færdiggørelse (Anslået)
12. oktober 2026
Studieafslutning (Anslået)
12. oktober 2026
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IMU-OT-STFOT-2026-01
Plan for individuelle deltagerdata (IPD)
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