Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02802956
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program
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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Impact Scale(SIS)', 'timeFrame': 'one year', 'description': 'quality of life measure'}], 'secondaryOutcomes': [{'measure': 'Postural Assessment Scale for Stroke patients(PASS)', 'timeFrame': 'one year', 'description': 'motor performance measure'}, {'measure': 'Action Research Arm Test(ARAT)', 'timeFrame': 'one year', 'description': 'motor performance measure'}, {'measure': 'Fugl-Meyer Assessment(FMA)', 'timeFrame': 'one year', 'description': 'motor performance measure'}, {'measure': 'self-rated abilities for health practice scale', 'timeFrame': 'one year', 'description': 'self-efficacy factors measure'}, {'measure': 'WHO Quality of Life-BREF (Taiwan version)', 'timeFrame': 'one year', 'description': 'quality of life measure'}, {'measure': 'Taiwan Instrumental Activities of Daily Living(TIADL)', 'timeFrame': 'one year', 'description': 'self-care ability measure'}, {'measure': 'Barthel Index', 'timeFrame': 'one year', 'description': 'self-care ability measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Life participation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke', 'detailedDescription': 'The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with stroke after 6 months.\n* Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must \\>20.\n\nExclusion Criteria:\n\n* Clinical diagnosis of Dementia or Psychosis.\n* Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases.\n* Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation.\n* Could not communication with others.\n* Foreigner.'}, 'identificationModule': {'nctId': 'NCT02802956', 'briefTitle': 'A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'National Taiwan University Hospital, Taiwan', 'orgStudyIdInfo': {'id': '201509087RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Daily Life Promotion Program', 'interventionNames': ['Other: Daily Life Promotion Program']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'general rehabilitation treatment', 'interventionNames': ['Other: general rehabilitation treatment']}], 'interventions': [{'name': 'Daily Life Promotion Program', 'type': 'OTHER', 'description': 'Daily Life Promotion Program', 'armGroupLabels': ['intervention group']}, {'name': 'general rehabilitation treatment', 'type': 'OTHER', 'description': 'general rehabilitation treatment', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'test3', 'city': 'Taipei', 'state': 'Test2', 'country': 'Taiwan', 'contacts': [{'name': 'Yang Yi-Jiun, BS', 'role': 'CONTACT', 'email': 'yangyijiun@yahoo.com.tw', 'phone': '886-2-23123456', 'phoneExt': '67313'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'I MING HSIAO', 'role': 'CONTACT', 'email': 'skipbeat227@gmail.com', 'phone': '886-2-23123456*70420'}, {'name': 'Yi-Jiun Yang', 'role': 'CONTACT', 'email': 'skipbeat227@gmail.com', 'phone': '886-2-23123456*66763'}], 'overallOfficials': [{'name': 'I MING HSIAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}