Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT05217394
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-25', 'size': 119346, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-26T21:00', 'hasProtocol': True}, {'date': '2021-10-01', 'size': 168980, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-25T21:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Print Tool', 'timeFrame': '2 weeks', 'description': 'Handwriting assessment'}], 'secondaryOutcomes': [{'measure': 'Test of Visual Perceptual Skills-4', 'timeFrame': '2 weeks', 'description': 'Visual perceptual skills assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['handwriting', 'intervention', 'effectiveness', 'children', 'study protocol', 'clustered randomized controlled trial'], 'conditions': ['Difficulty Writing']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children.\n\nMethod:\n\nForty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine years, will be assigned to the experimental and control groups.\n\nParticipants will receive a total of 10-week sessions, including training, intervention, and outcome measures.\n\nThe experimental group will receive the developed OTHIG during handwriting skills intervention. Meanwhile, the control group will receive conventional interventions which not exposed to the OTHIG.\n\nThis study is expected to provide evidence for the effectiveness of using the developed OTHIG to OTs in delivering their services, targeting children struggling with handwriting skills.', 'detailedDescription': 'The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the centers into the treatment and control groups.\n\nA total of 10 centers will be involved in this study.\n\nThe clustering of all ten centers will allocate randomly into the treatment and control groups based on submitting the consent letter to the researcher and after an assessment of TPT and TVPS-4 are conducted.\n\nTen early interventions have similar characteristics such as (1) hiring graduated occupational therapists from recognized universities in Malaysia, (2) having occupational therapists working daily at the centre, (3) having children aged five to nine years who receive OTs intervention.\n\nThis randomization will be allocated based on the list of the centers that give an early submission of a signed consent form. The randomization will be carried out with a mechanism that neither the researcher nor children or center owners will know which group of intervention they will be assigned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between five and nine years\n* engaged in OTs intervention either in an individual or group session.\n\nExclusion Criteria:\n\n* refuse to participate in the study\n* fail to comply with the whole intervention process during the study\n* present severe sensory problems\n* present poor behavior during intervention'}, 'identificationModule': {'nctId': 'NCT05217394', 'briefTitle': 'Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial', 'orgStudyIdInfo': {'id': 'FRGS/1/2020/SSI0/UKM/03/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OTHIG', 'description': 'Occupational Therapy Handwriting Intervention Guideline - this is the experimental guideline to be tested in this study.\n\nSection C: Intervention for Handwriting Readiness Skills\n\n* Handwriting development\n* Pre-writing skills\n* Gross motor skills activities\n* Fine motor skills activities\n* Motor visual skills activities Section D: Intervention for Handwriting Skills\n* Handwriting tools\n* Pencil grasp\n* Posture and position\n* Hand dominance\n* Writing capitals, lowercase, and numbers\n* Handwriting speed Section E: Handwriting Intervention Module\n* Session 1: Development of Handwriting Skills Activities\n* Session 2: Pre-writing Skills Activities\n* Session 3: Gross and Fine Motor Skills Activities\n* Session 4: Writing Capital Letters\n* Session 5: Writing Lowercase Letters\n* Session 6: Writing Numbers', 'interventionNames': ['Other: OTHIG']}, {'type': 'NO_INTERVENTION', 'label': 'NOTi', 'description': 'Natural Occupational Therapy Intervention - this means, the participants in this group are not exposed to the OTHIG. They receive natural OT intervention without exposure to the OTHIG.\n\nThe natural OT intervention includes:\n\nGross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring.\n\nIt will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia.\n\nThe natural OT intervention includes:\n\nGross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring.\n\nIt will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia.'}], 'interventions': [{'name': 'OTHIG', 'type': 'OTHER', 'description': 'Occupational Therapy Handwriting Intervention Guideline', 'armGroupLabels': ['OTHIG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Jitra', 'state': 'Kedah', 'country': 'Malaysia', 'facility': 'Kiddie Care Centre', 'geoPoint': {'lat': 6.26812, 'lon': 100.42167}}, {'zip': '62150', 'city': 'Putrajaya', 'state': 'PU', 'country': 'Malaysia', 'facility': 'Ryan Special Needs Rehabilitation Centre', 'geoPoint': {'lat': 2.93527, 'lon': 101.69112}}, {'city': 'Bangi', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Excel Qhalif Playgroup Centre', 'geoPoint': {'lat': 2.9, 'lon': 101.78333}}, {'city': 'Shah Alam', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Kizzu Kids Centre', 'geoPoint': {'lat': 3.08507, 'lon': 101.53281}}], 'overallOfficials': [{'name': 'Masne Kadar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Health Sciences, UKM'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'October 2021 until September 2022', 'ipdSharing': 'YES', 'description': 'All data collected will be shared among researchers', 'accessCriteria': 'Study protocol will be shared with all researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Education, Malaysia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}