Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT01037894
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2009-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], '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': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-10', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glasgow Outcome Scale Extended', 'timeFrame': 'Six week'}], 'secondaryOutcomes': [{'measure': 'Functional Independence Measure (FIM) score', 'timeFrame': 'Six week'}, {'measure': 'Modified Aschoff Score', 'timeFrame': 'Six week'}, {'measure': 'Neurocognitive State Examination(NCSE)score', 'timeFrame': 'Six week'}, {'measure': 'Motor scores of upper limb and lower limb with Fugl-Meyer Scale', 'timeFrame': 'six week'}, {'measure': 'Modified Functional Ambulation Category (MFAC)', 'timeFrame': 'Six week'}, {'measure': 'Modified Rivermead Mobility Index (MRMI)', 'timeFrame': 'Six week'}, {'measure': 'Barthel Index', 'timeFrame': 'Six week'}, {'measure': 'Modified Rankin Scale', 'timeFrame': 'Six week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acupuncture,Intracerebral hemorrhage, Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.', 'detailedDescription': 'The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).\n\nPrimary outcome measures:\n\nClinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.\n\nSecondary outcome measures:\n\nModified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient inclusion Criteria:\n\n1. Patients after acute hemorrhagic stroke;\n2. Within the first month after acute presentation;\n3. Premorbid mobility level: Independent Indoor or Outdoor Walker;\n4. Co-operative and willing to comply with the rehabilitation program;\n\nPatient exclusion Criteria:\n\n1. Cardiac Pacemaker;\n2. Patient who is apprehensive to acupuncture;\n3. Clotting abnormality;\n4. Poor local skin conditions.'}, 'identificationModule': {'nctId': 'NCT01037894', 'briefTitle': 'Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?', 'orgStudyIdInfo': {'id': 'GW003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Acupuncture and conventional rehabilitation', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Conventional rehabilitation only', 'interventionNames': ['Procedure: Conventional rehabilitation']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.', 'armGroupLabels': ['Acupuncture']}, {'name': 'Conventional rehabilitation', 'type': 'PROCEDURE', 'description': 'In-patient physiotherapy, occupational therapy and speech therapy.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'George KC Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Neurosurgery, CUHK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (Clinical)', 'investigatorFullName': 'George KC Wong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}