Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-12 @ 11:26 AM
Study NCT ID:
NCT06522802
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2024-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Wearing a Mask for Balance and Reaction Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional reach test', 'timeFrame': 'baseline-5 hours later', 'description': 'Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task. As we know that this test measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.'}], 'secondaryOutcomes': [{'measure': 'COP displacement', 'timeFrame': 'baseline-5 hours later', 'description': 'Displacement of the center of pressure (COP) and center of gravity (COG) a: COP ML displacement. Distance of the inflection point from a stationary baseline. b: Maximum ML separation. Maximum distance between the COP and COG. Source publication.'}, {'measure': 'BlazePod evaluation', 'timeFrame': 'baseline-5 hours later', 'description': 'A new technology (BlazePod™) that measures response time (RT) is currently on the market and has been used by strength and conditioning professionals.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reaction Time', 'Balance']}, 'descriptionModule': {'briefSummary': "A mask is a protective equipment that covers the mouth and nose and is routinely used in workplaces, public transport and other communal settings preventing harmful particles, dust, droplets, bacteria, viruses, fog, gas, smoke and steam from entering the respiratory system. However, wearing a mask may impair the visual field, potentially affecting balance and reaction time. The investigators' aim is to determine whether the use of masks affects people's balance and reactions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be healthy\n\nExclusion Criteria:\n\n* present or previous balance disorder'}, 'identificationModule': {'nctId': 'NCT06522802', 'briefTitle': 'The Effect of Wearing a Mask for Balance and Reaction Time', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Does Wearing a Mask Affect Balance and Reaction Time?', 'orgStudyIdInfo': {'id': '10840098-772.02-E.43565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation Arm', 'description': 'Only one group evaluated', 'interventionNames': ['Diagnostic Test: balance tests, reaction time evaluation']}], 'interventions': [{'name': 'balance tests, reaction time evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Only 3 tests were applied to participants', 'armGroupLabels': ['Evaluation Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, MSc, PhD', 'investigatorFullName': 'yasin yildirim', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}