- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07723092
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
23 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Istanbul
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Istanbul, Istanbul, Turkiet (Türkiye)
- Güngören Yahya Çavuş Primary School
-
Kontakt:
- Merve Keskin, MSc
- Telefonnummer: +90 5375825256
- E-post: mervekeskiin98@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Handwriting Performance Assessed by the Minnesota Handwriting Test
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test
Tidsram: 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
Tidsram: 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.
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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
Tidsram: 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.
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Baseline and within 1 week after completion of the 10-week intervention (up to Week 11)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
27 juli 2026
Primärt slutförande (Beräknad)
12 oktober 2026
Avslutad studie (Beräknad)
12 oktober 2026
Studieregistreringsdatum
Först inskickad
20 juli 2026
Först inskickad som uppfyllde QC-kriterierna
20 juli 2026
Första postat (Faktisk)
23 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IMU-OT-STFOT-2026-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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