Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 10:46 AM
Study NCT ID:
NCT03982251
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Whole Body Vibration in People With Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-09', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-06-09', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone resorption marker', 'timeFrame': 'pre-test (week 0)', 'description': 'Serum level of aminoterminal crosslinked telopeptide'}, {'measure': 'bone resorption marker', 'timeFrame': 'post-test (week8)', 'description': 'Serum level of aminoterminal crosslinked telopeptide'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Test', 'timeFrame': 'pre-test (week 0)', 'description': 'endurance test'}, {'measure': 'Six Minute Walk Test', 'timeFrame': 'post-test (week8)', 'description': 'endurance Test'}, {'measure': 'Gait velocity', 'timeFrame': 'pre-test (week 0)', 'description': '10-meter walking test'}, {'measure': 'Gait velocity', 'timeFrame': 'post-test (week8)', 'description': '10-meter walking test'}, {'measure': 'Spasticity', 'timeFrame': 'pre-test (week 0)', 'description': 'H-reflex on tibial nerve and modified ashworth scale'}, {'measure': 'Spasticity', 'timeFrame': 'post-test (week8)', 'description': 'H-reflex on tibial nerve and modified ashworth scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vibration', 'bone', 'mucle', 'cerebrovascular accident', 'rehabilitation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.\n\nIt is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function.', 'detailedDescription': 'Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.\n\nIt is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function in people with chronic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a diagnosis of stroke\n2. stroke onset \\>6 months\n3. \\>18 years of age\n4. able to walk for short distance independently with or without walking aid\n5. able to understand simple verbal commands\n\nExclusion Criteria:\n\n1. neurological conditions other than stroke\n2. significant musculoskeletal conditions (e.g. amputations)\n3. metal implants in the lower extremity\n4. previous fracture of the lower extremity\n5. are currently taking bone resorption inhibitors or were taking the same before stroke.\n6. significant peripheral vascular disease\n7. vestibular disorders\n8. pregnancy\n9. Other serious illnesses that preclude the person from participating in the study'}, 'identificationModule': {'nctId': 'NCT03982251', 'briefTitle': 'The Effects of Whole Body Vibration in People With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'The Effects of Whole Body Vibration Training With Different Frequencies on Bone Health and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'HSEARS20140226001-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High frequency whole body vibration', 'description': 'This group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz.', 'interventionNames': ['Procedure: High frequency whole body vibration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low frequency whole body vibration', 'description': 'This group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz.', 'interventionNames': ['Procedure: Low frequency whole body vibration']}], 'interventions': [{'name': 'High frequency whole body vibration', 'type': 'PROCEDURE', 'otherNames': ['Whole body vibration therapy (30Hz)'], 'description': '1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz', 'armGroupLabels': ['High frequency whole body vibration']}, {'name': 'Low frequency whole body vibration', 'type': 'PROCEDURE', 'otherNames': ['Whole body vibration therapy (20Hz)'], 'description': '1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz', 'armGroupLabels': ['low frequency whole body vibration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], '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': 'Professor', 'investigatorFullName': 'Marco Yiu-Chung Pang', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}