Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-01-20 @ 5:27 PM
Study NCT ID:
NCT02043106
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle activity', 'timeFrame': 'up to 2 months after experiment', 'description': 'Muscle activity will be measured by electromyography equipment (two electrodes placed on the muscle belly) and then the outcome measures will be the description of both the timing (relative to task onset) and magintude of muscle activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': "Participants will be asked to complete three different tests (standing, stepping and assisted walking) and will experience three different experimental conditions during each test. The three conditions are types of vibratory plantar cutaneous stimulation, which include no vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory stimulation. In the first condition, participants will experience no stimulation applied to any part of the body. In the second condition, a submaximal vibratory stimulus will be delivered at 90% of the participant's threshold to the surface of the foot. In the third condition, a supramaximal vibratory stimulus will be delivered at three times the participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is positive then this protocol will also be presented in incomplete spinal cord injuried participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no spinal cord injury\n\nExclusion Criteria:\n\n* any musculoskeletal or neurological disease that affects movement or balance'}, 'identificationModule': {'nctId': 'NCT02043106', 'briefTitle': 'Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?', 'organization': {'class': 'OTHER', 'fullName': 'Wilfrid Laurier University'}, 'officialTitle': 'Plantar Cutaneous Stimulation Used to Elicit Muscle Activity in Individuals With Incomplete Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'MC_SCIPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'spinal cord injury', 'description': 'Individuals who have sustained an incomplete spinal cord injury', 'interventionNames': ['Other: plantar vibration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-spinal cord injury', 'description': 'Individuals who have not sustained a spinal cord injury', 'interventionNames': ['Other: plantar vibration']}], 'interventions': [{'name': 'plantar vibration', 'type': 'OTHER', 'armGroupLabels': ['non-spinal cord injury', 'spinal cord injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3C5', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Biomechanics Lab, Wilfrid Laurier University', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Stephen D Perry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wilfrid Laurier University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wilfrid Laurier University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoicate Professor', 'investigatorFullName': 'Dr. Stephen Perry', 'investigatorAffiliation': 'Wilfrid Laurier University'}}}}