Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 7:47 AM
Study NCT ID:
NCT06622460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-02
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VET Evaluation: Healthy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Threshold from the Virtual Eggs Test (VET)', 'timeFrame': 'First Session (Test)', 'description': "This refers to the grip strength threshold required to avoid breaking fragile objects during the test. The VET measures the participant's ability to regulate grip strength and dexterity, with the threshold ranging from 1 to 20. Lower numbers indicate that less force is needed to break the object, reflecting greater control over fine motor skills"}, {'measure': 'Threshold from the Virtual Eggs Test (VET)', 'timeFrame': 'Second Session (Re-Test)', 'description': "This refers to the grip strength threshold required to avoid breaking fragile objects during the test. The VET measures the participant's ability to regulate grip strength and dexterity, with the threshold ranging from 1 to 20. Lower numbers indicate that less force is needed to break the object, reflecting greater control over fine motor skills"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The study involving healthy participants aims to validate the Virtual Eggs Test (VET) as a tool for measuring hand dexterity and grip force control. This part of the study focuses on determining the test's reliability and validity in a population without motor impairments. Healthy participants will perform the VET using both their dominant and non-dominant hands across two sessions. The purpose is to establish baseline performance metrics for comparison with stroke patients and to assess the test's usability in clinical settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 85 years.\n* No motor deficits.\n* Adequate cognitive and language abilities to understand the experiment and follow instructions.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Significant visual or oculomotor impairments.\n* Comorbidities or disabilities that may interfere with the study, such as multiple sclerosis, Parkinson's disease, or muscle tone disorders.\n* Cardiopulmonary or circulatory pathologies.\n* Pregnancy or breastfeeding.\n* Psychiatric comorbidities.\n* Difficulty understanding the Italian language.\n* Lack of cooperation.\n* Consumption of alcohol or diuretics before the test"}, 'identificationModule': {'nctId': 'NCT06622460', 'acronym': 'VET_Healthy', 'briefTitle': 'VET Evaluation: Healthy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Experimental Evaluation of the Virtual Eggs Test on Healthy Participants', 'orgStudyIdInfo': {'id': 'VirtualEggTest_Healthy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Hand Control Group (HHC Group)', 'description': 'The Healthy Hand Control Group (HHC Group) consists of participants without motor impairments, selected to establish baseline data for hand dexterity and grip strength using the Virtual Eggs Test (VET).', 'interventionNames': ['Other: Hand Dexterity Assessment']}], 'interventions': [{'name': 'Hand Dexterity Assessment', 'type': 'OTHER', 'description': 'to evaluate the reliability and sensitivity of the VET in healthy. Their performance helps define normal thresholds and behaviors in grip force modulation and manual dexterity.', 'armGroupLabels': ['Healthy Hand Control Group (HHC Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50143', 'city': 'Florence', 'state': 'Florence', 'country': 'Italy', 'facility': 'Fondazione Don Carlo Gnocchi ONLUS', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scuola Superiore Sant'Anna di Pisa', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francesca Cecchi', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}