Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
Study NCT ID:
NCT06871566
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI-Supported Occupational Therapy for Handwriting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single blind'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minnesota Handwriting Assessment', 'timeFrame': 'Two assessments, one week before the intervention and one week after the intervention was completed', 'description': '(MHA) assesses six categories of handwriting, including legibility, form, alignment, size, spacing and writing speed. The MHA consists of words that include all letters of the Turkish alphabet at least once and consist of 34 letters in total, and can be understood by children at the primary school level 23. In the test application, children copy this word sequence written on the paper to the marked line immediately below. In the scoring phase, the length of 1/16 inch (0.15 cm) is taken as a basis and all deviations, proportions between letters and within letters are evaluated by measuring this length with a ruler. The lowest score in each category of the MHA is 0 and the highest score is 34 24.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artifical intellegence', 'occupational therapy', 'developmental coordination disorders', 'handwriting', 'rehabilitation'], 'conditions': ['Occupational Therapy']}, 'descriptionModule': {'briefSummary': 'Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).\n\nMethod: A randomized controlled trial was conducted with 42 children aged 8-12 years, identified as being at risk for DCD using the Developmental Coordination Disorder Questionnaire (DCDQ). Participants were randomized into an intervention group (n=21) and a control group (n=21). The intervention group received an AI-supported occupational therapy program twice weekly for 8 weeks. Handwriting performance was assessed pre- and post-intervention using the Minnesota Handwriting Assessment (MHA).\n\nKeywords: artificial intelligence, occupational'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. being between the ages of 8-12 years\n2. being at risk for DCD according to the Developmental Coordination Disorder Questionnaire (DCDQ)\n3. having the ability to understand the questionnaires\n4. continuing formal education\n5. having similar motor skill performance (having similar results from the Bruininks-Oseretsky Motor Proficiency Test 2 Brief Form (BOT2-BF)) and having similar visual perception level (having similar results from the Motor-Free Visual Perception Test-3(MVPT-3)\n\nExclusion Criteria:\n\n(1) having another neurodevelopmental, orthopedic and chronic problem (2) continuing any rehabilitation program\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06871566', 'briefTitle': 'AI-Supported Occupational Therapy for Handwriting', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Artificial Intelligence-Supported Occupational Therapy Program on Handwriting Skills in Children at Risk for Developmental Coordination Disorder: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024-242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Children at Risk for Developmental Coordination Disorder', 'interventionNames': ['Other: Artificial Intelligence-Supported Occupational Therapy Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Children at Risk for Developmental Coordination Disorder'}], 'interventions': [{'name': 'Artificial Intelligence-Supported Occupational Therapy Program', 'type': 'OTHER', 'description': 'The AI-supported occupational therapy program was individually implemented by an occupational therapist over 8 weeks, with 2 sessions per week, each lasting 45 minutes. A touchscreen tablet, touch pen, and external camera were utilized during the sessions. At the beginning of the program, technological devices and artificial intelligence tools were introduced to the children. For the goals and detailed intervention program of the 8-week schedule', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Güleser Güney Yılmaz', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Occupational Therapist', 'investigatorFullName': 'Güleser Güney Yılmaz', 'investigatorAffiliation': 'Hacettepe University'}}}}