- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07723092
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
23 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
24
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Istanbul
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Istanbul, Istanbul, Turquie (Türkiye)
- Güngören Yahya Çavuş Primary School
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Contact:
- Merve Keskin, MSc
- Numéro de téléphone: +90 5375825256
- E-mail: mervekeskiin98@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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|
Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Handwriting Performance Assessed by the Minnesota Handwriting Test
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Manual Dexterity Assessed by the Minnesota Manual Dexterity Test
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Individualized Goal Attainment Assessed by Goal Attainment Scaling
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
27 juillet 2026
Achèvement primaire (Estimé)
12 octobre 2026
Achèvement de l'étude (Estimé)
12 octobre 2026
Dates d'inscription aux études
Première soumission
20 juillet 2026
Première soumission répondant aux critères de contrôle qualité
20 juillet 2026
Première publication (Réel)
23 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IMU-OT-STFOT-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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