Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT01862393
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2013-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2013-05-17', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Torque', 'timeFrame': 'During 4 seconds of electrical stimulation', 'description': 'Torque will be measured using an isokinetic dynamometer. Torque will be registered in Newton meter \\[N.m\\]'}], 'secondaryOutcomes': [{'measure': 'Discomfort', 'timeFrame': 'During 6 seconds of electrical stimulation', 'description': 'Discomfort will be measured using a 10 cm visual analogue scale (VAS) ranging from zero (no discomfort) to 10 (worst discomfort imaginable).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electrical stimulation', 'torque'], 'conditions': ['Torque', 'Pain Perception']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sedentary healthy university students.\n\nExclusion Criteria:\n\n* history of knee surgery or injury,\n* musculoskeletal, cardiovascular or neurological disease including impaired sensation.'}, 'identificationModule': {'nctId': 'NCT01862393', 'briefTitle': 'Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'The Influence of Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris', 'orgStudyIdInfo': {'id': 'CAAE - 0081.0.186.000-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '400 microseconds', 'description': 'Electrically-induced torque generated with stimulus phase duration set at 400 microseconds.', 'interventionNames': ['Device: 400 microseconds']}, {'type': 'EXPERIMENTAL', 'label': '700 microseconds', 'description': 'Electrically-induced torque generated with stimulus phase duration set at 700 microseconds.', 'interventionNames': ['Device: 700 microseconds']}, {'type': 'EXPERIMENTAL', 'label': '1000 microseconds', 'description': 'Electrically-induced torque generated with stimulus phase duration set at 1000 microseconds.', 'interventionNames': ['Device: 1000 microseconds']}], 'interventions': [{'name': '400 microseconds', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds', 'armGroupLabels': ['400 microseconds']}, {'name': '700 microseconds', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds', 'armGroupLabels': ['700 microseconds']}, {'name': '1000 microseconds', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds', 'armGroupLabels': ['1000 microseconds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03071-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Cidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Richard E Liebano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Cidade de Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Eloin Liebano', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}