Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT02694666
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real life falls', 'timeFrame': 'Up to 12 months', 'description': 'Real life falls are monitored for 12 months.'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale test', 'timeFrame': 'Up to 12 months', 'description': 'This test is used to assess the body balance skill in healthy elderly.'}, {'measure': 'Slip-related falls on treadmill', 'timeFrame': 'Up to 12 months', 'description': 'Participants will be exposed to unexpected slips during walking on a treadmill.'}, {'measure': 'Functional mobility', 'timeFrame': 'Up to 12 months', 'description': 'Functional mobility is measured by using the Timed-Up-and-Go test.'}, {'measure': 'Sensation', 'timeFrame': 'Up to 12 months', 'description': 'Sensation is measured by nylon monofilaments kit.'}, {'measure': 'Muscle strength', 'timeFrame': 'Up to 12 months', 'description': "Lower-limb joints' muscle strengths are evaluated by an isokinetic dynamometer."}, {'measure': 'Range of motion', 'timeFrame': 'Up to 12 months', 'description': 'The range of motion of the lower limb joints are assessed by a goniometer.'}, {'measure': 'Bone density', 'timeFrame': 'Up to 12 months', 'description': 'The bone density of the heel bone is assessed by a bone ultrasonometer.'}, {'measure': 'Multiple Sclerosis Functional Composite score', 'timeFrame': 'Up to 12 months', 'description': 'The Multiple Sclerosis Functional Composite score, which indicates the disability level in people with multiple sclerosis, is measured'}, {'measure': 'Equiscale balance test', 'timeFrame': 'Up to 12 months', 'description': 'This balance test is applied to individuals with multiple sclerosis to evaluate their body balance skill.'}, {'measure': 'Symbol Digit Modalities test', 'timeFrame': 'Up to 12 months', 'description': "This test measures participants' attention and information processing speed and efficiency."}, {'measure': 'Selective Reminding test', 'timeFrame': 'Up to 12 months', 'description': "This instrument assesses participants' verbal learning and memory capacity."}, {'measure': 'Behavior Rating Inventory of Executive Function', 'timeFrame': 'Up to 12 months', 'description': "This test is used to gauge one's everyday behaviors associated with specific domains of the executive functions."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Falls Prevention']}, 'referencesModule': {'references': [{'pmid': '36781617', 'type': 'DERIVED', 'citation': 'Yang F, Su X, Sanchez MC, Hackney ME, Butler AJ. Vibration training reducing falls in community-living older adults: a pilot randomized controlled trial. Aging Clin Exp Res. 2023 Apr;35(4):803-814. doi: 10.1007/s40520-023-02362-6. Epub 2023 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate the effects of controlled whole-body vibration training on reducing the likelihood of falls among healthy population and people with multiple sclerosis. (NOTE: research not covered by sponsored funding)', 'detailedDescription': 'For each population, the participants will be randomized into two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor healthy population:\n\n* Aged between 18 and 75\n* No known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment\n\nFor people with multiple sclerosis\n\n* Self-reported multiple sclerosis and confirmed by the physician\n* No significant relapse within the past 8 weeks\n* To be able to walk independently a length of 25 feet\n* Score on Patient Determined Disease Step \\< 7\n\nExclusion Criteria:\n\n* Subjects use any sedative of any type.\n* The heel bone density is less than -2.0'}, 'identificationModule': {'nctId': 'NCT02694666', 'briefTitle': 'Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Georgia State University'}, 'officialTitle': 'Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '514810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vibration training group', 'description': 'The vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device', 'interventionNames': ['Other: Controlled whole-body vibration training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo training group', 'description': 'The placebo group will receive 8-week placebo training on the Galileo Med L device', 'interventionNames': ['Other: Controlled whole-body vibration training']}], 'interventions': [{'name': 'Controlled whole-body vibration training', 'type': 'OTHER', 'otherNames': ['Vibration therapy; vibration training'], 'description': 'The intervention is an 8-week program', 'armGroupLabels': ['Placebo training group', 'Vibration training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia State University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Feng Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Feng Yang, PhD', 'investigatorAffiliation': 'Georgia State University'}}}}