Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT05010993
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2021-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Czech Norms of Selected Standardized Tests
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'results from the Nine Hole Peg Test', 'timeFrame': '10 minutes', 'description': 'time in seconds and hundreds of seconds'}, {'measure': 'results from the Purdue Pegboard Test', 'timeFrame': '25 minutes', 'description': 'number of parts put in the Pegboard according to the rules'}, {'measure': 'results from the Box and Block Test', 'timeFrame': '30 minutes', 'description': 'number of transported blocks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['standardized test', 'occupational therapy', 'fine motor skills', 'Nine Hole Peg Test', 'Purdue Pegboard Test', 'Box and Block Test', 'Czech language', 'norms', 'healthy population'], 'conditions': ['Motor Activity']}, 'descriptionModule': {'briefSummary': 'The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.', 'detailedDescription': 'The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.\n\nThe Czech updated manuals for those tests were made by back-translation method and updated for unification of recommended three trials of each subtest administration and interpretation of tested individuals performance.\n\nAt least 540 individuals (20-65 years old) will be tested by the updated Czech manuals till the end of 2023 by those three tests. The Czech norms will be established from acquired data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Czech healthy men and women', 'genderDescription': 'based on self-representation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Czech language as a mother tongue\n* age from 20 to 65 years\n\nExclusion Criteria:\n\n* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs\n* use of drugs affecting attention\n* vision impairment uncorrectable with glasses\n* severe hearing loss\n* inability to understand instructions\n* inability to read or write\n* inability to complete testing\n* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague'}, 'identificationModule': {'nctId': 'NCT05010993', 'briefTitle': 'Establishing Czech Norms of Selected Standardized Tests', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Establishing Czech Norms of Selected Standardized Tests for Use in Rehabilitation and Upper Limbs Functional Evaluation', 'orgStudyIdInfo': {'id': 'EK-1340.14/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Czech healthy people', 'description': 'Czech healthy men and women will be asked to fill in a questionnaire. Then they will be tested by the Nine Hole Peg Test, the Purdue Pegboard Test and the Box and Block Test.', 'interventionNames': ['Diagnostic Test: Nine Hole Peg Test', 'Diagnostic Test: Purdue Pegboard Test', 'Diagnostic Test: Box and Block Test']}], 'interventions': [{'name': 'Nine Hole Peg Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each person will be tested by the Nine Hole Peg Test (3 attempts per subtest)', 'armGroupLabels': ['Czech healthy people']}, {'name': 'Purdue Pegboard Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each person will be tested by the Purdue Pegboard Test (3 attempts per subtest)', 'armGroupLabels': ['Czech healthy people']}, {'name': 'Box and Block Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each person will be tested by the Box and Block Test (3 attempts per subtest)', 'armGroupLabels': ['Czech healthy people']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Kateřina Rybářová, Mgr.', 'role': 'CONTACT', 'email': 'katerina.rybarova@lf1.cuni.cz', 'phone': '224968517'}], 'facility': 'Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Kateřina Rybářová, Mgr.', 'role': 'CONTACT', 'email': 'katerina.rybarova@lf1.cuni.cz', 'phone': '224968517'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mgr. Kateřina Rybářová (Master in Occupational Therapy)', 'investigatorFullName': 'Kateřina Rybářová', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}