Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03963258
Status:
UNKNOWN
Last Update Posted:
2019-07-02
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-01', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'upper-extremity Fugl-Meyer Scale', 'timeFrame': 'After the 3-week intervention period', 'description': 'the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability'}, {'measure': 'Wolf Motor Function Test', 'timeFrame': 'After the 3-week intervention period', 'description': 'participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.'}, {'measure': 'Surface electromyography', 'timeFrame': 'After the 3-week intervention period', 'description': 'Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whole-Body vibration', 'Stroke', 'Hemiplegia', 'upper extremity', 'Rehabilitation training', 'Muscular surface EMG', 'Vibration training'], 'conditions': ['Rehabilitation', 'Stroke', 'Hemiplegia', 'Physical Therapy Modalities', 'Electromyography', 'Upper Extremity', 'Recovery of Function', 'Vibration']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* After unilateral stroke 1 to 6 months\n* An ischemic or hemorrhagic poststroke hemiplegia\n* No cognitive impairment\n* Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms\n* No excessive pain in the more affected upper extremity\n* All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation\n\nExclusion Criteria:\n\n* Unsteadiness\n* Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors\n* Contraindications to general vibration training exist\n* Combined with other diseases causing upper limb dysfunction'}, 'identificationModule': {'nctId': 'NCT03963258', 'briefTitle': 'Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia', 'orgStudyIdInfo': {'id': 'IRB00006761-M2018112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Over a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning', 'interventionNames': ['Other: conventional upper limb training']}, {'type': 'EXPERIMENTAL', 'label': 'whole-body vibration group', 'description': 'Subjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period', 'interventionNames': ['Device: whole-body vibration training']}], 'interventions': [{'name': 'whole-body vibration training', 'type': 'DEVICE', 'otherNames': ['vibration training'], 'description': 'The subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board', 'armGroupLabels': ['whole-body vibration group']}, {'name': 'conventional upper limb training', 'type': 'OTHER', 'description': 'compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'No State Or Province', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongbo Li, bachelor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking Univercity Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'mouwang zhou, master', 'role': 'CONTACT', 'email': 'zhoumouwang@163.com', 'phone': '13910092892'}, {'name': 'hongbo Li, bachelor', 'role': 'CONTACT', 'email': '1184455890@qq.com', 'phone': '17778025997'}], 'overallOfficials': [{'name': 'mouwang zhou, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Rehabilitation Medicine , Principal Investigator, Clinical Professor', 'investigatorFullName': 'Mouwang Zhou', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}