Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 6:48 AM
Study NCT ID:
NCT01822704
Status:
UNKNOWN
Last Update Posted:
2013-04-04
First Post:
2013-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Vibration in Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-01', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isometric knee muscle strength', 'timeFrame': 'Week 0'}, {'measure': 'Isometric knee muscle strength', 'timeFrame': 'week 10'}], 'secondaryOutcomes': [{'measure': 'Eccentric knee muscle strength at a velocity of 60 degrees per second', 'timeFrame': 'Week 0'}, {'measure': 'Eccentric knee muscle strength at a velocity of 60 degrees per second', 'timeFrame': 'week 10'}, {'measure': 'Concentric knee muscle strength at a velocity of 60 degrees per second', 'timeFrame': 'week 0'}, {'measure': 'Concentric knee muscle strength at a velocity of 60 degrees per second', 'timeFrame': 'week 10'}, {'measure': 'Distance walked in the Six Minute Walk Test', 'timeFrame': 'week 0'}, {'measure': 'Distance walked in the Six Minute Walk Test', 'timeFrame': 'week 10'}, {'measure': 'Average oxygen consumption rate during the Six Minute Walk Test', 'timeFrame': 'week 0'}, {'measure': 'Average oxygen consumption rate during the Six Minute Walk Test', 'timeFrame': 'week 10'}, {'measure': 'Time taken to complete the Timed Up and Go Test', 'timeFrame': 'week 0'}, {'measure': 'Time taken to complete the Timed Up and Go Test', 'timeFrame': 'week 10'}, {'measure': 'Time taken to complete the Five-times-sit-to-stand test', 'timeFrame': 'week 0'}, {'measure': 'Time taken to complete the Five-times-sit-to-stand test', 'timeFrame': 'week 10'}, {'measure': 'Distance reached in the Functional Reach test', 'timeFrame': 'Week 0'}, {'measure': 'Distance reached in the Functional Reach test', 'timeFrame': 'week 10'}, {'measure': 'Balance score as measured by the Mini-Balance Evaluation Systems Test', 'timeFrame': 'week 0'}, {'measure': 'Balance score as measured by the Mini-Balance Evaluation Systems Test', 'timeFrame': 'week 10'}, {'measure': 'Walking ability as measured by the Functional Ambulation Category', 'timeFrame': 'week 0'}, {'measure': 'Walking ability as measured by the Functional Ambulation Category', 'timeFrame': 'week 10'}, {'measure': 'Balance confidence scores as measured by the Activities-specific Balance Confidence Scale', 'timeFrame': 'week 0'}, {'measure': 'Balance confidence scores as measured by the Activities-specific Balance Confidence Scale', 'timeFrame': 'week 10'}, {'measure': 'Quality of life score as measured by the 12-item Short Form Health Survey', 'timeFrame': 'week 0'}, {'measure': 'Quality of life score as measured by the 12-item Short Form Health Survey', 'timeFrame': 'week 10'}, {'measure': 'Level of activity participation as measured by the Frenchay Activities Index', 'timeFrame': 'week 0'}, {'measure': 'Level of activity participation as measured by the Frenchay Activities Index', 'timeFrame': 'Week 10'}, {'measure': 'Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors', 'timeFrame': 'week 0'}, {'measure': 'Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors', 'timeFrame': 'week 10'}, {'measure': 'Ankle spasticity score as measured by the Modified Ashworth Scale', 'timeFrame': 'week 0'}, {'measure': 'Ankle spasticity score as measured by the Modified Ashworth Scale', 'timeFrame': 'week 10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Exercise', 'Rehabilitation', 'Vibration'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '22330025', 'type': 'BACKGROUND', 'citation': 'Lau RW, Yip SP, Pang MY. Whole-body vibration has no effect on neuromotor function and falls in chronic stroke. Med Sci Sports Exerc. 2012 Aug;44(8):1409-18. doi: 10.1249/MSS.0b013e31824e4f8c.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of a hemispheric stroke\n* chronic stroke (onset of 6 months or more)\n* aged 18 years or older\n* medically stable\n* able to stand for at least 1 minute with hand support\n* Abbreviated Mental Test score at 6 or more\n* Chedoke McMaster Stroke Assessment leg or foot score less than 7 points\n\nExclusion Criteria:\n\n* recurrent stroke\n* brainstem or cerebellar stroke\n* other neurological conditions\n* significant musculoskeletal conditions (e.g. amputations)\n* vestibular disorders\n* peripheral vascular disease\n* other serious illnesses\n* other contraindications to exercise.'}, 'identificationModule': {'nctId': 'NCT01822704', 'briefTitle': 'Whole Body Vibration in Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy', 'orgStudyIdInfo': {'id': 'HSEARS20130209001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.', 'interventionNames': ['Behavioral: Leg exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Low intensity vibration', 'description': 'This group will receive three 45-minute whole body vibration training sessions for 10 consecutive weeks. The vibration will be of low intensity (frequency: 20 Hertz, amplitude: 1mm).', 'interventionNames': ['Device: Low intensity whole body vibration', 'Behavioral: Leg exercises']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity vibration', 'description': 'This group will receive three 45-minute whole body vibration training sessions per week for 10 consecutive weeks.The vibration will be of higher intensity than the low intensity vibration group (frequency: 30 Hertz, amplitude: 1mm).', 'interventionNames': ['Device: High intensity whole body vibration', 'Behavioral: Leg exercises']}], 'interventions': [{'name': 'Low intensity whole body vibration', 'type': 'DEVICE', 'armGroupLabels': ['Low intensity vibration']}, {'name': 'High intensity whole body vibration', 'type': 'DEVICE', 'armGroupLabels': ['High intensity vibration']}, {'name': 'Leg exercises', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control', 'High intensity vibration', 'Low intensity vibration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hung Hom', 'state': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Alan Liao, MPT', 'role': 'CONTACT', 'email': 'lr-liao@126.com', 'phone': '852-2766-4845'}, {'name': 'Marco Y Pang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.30715, 'lon': 114.18532}}], 'centralContacts': [{'name': 'Marco YC Pang, PhD', 'role': 'CONTACT', 'email': 'Marco.Pang@polyu.edu.hk', 'phone': '852-2766-7156'}], 'overallOfficials': [{'name': 'Marco YC Pang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marco Yiu-Chung Pang', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}