Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-29 @ 10:00 AM
Study NCT ID:
NCT01721668
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2012-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': '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': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2012-11-01', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in performance on Action Research Arm Test', 'timeFrame': 'Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up', 'description': 'Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.'}, {'measure': 'Change in performance on Chedoke Arm and Hand Inventory', 'timeFrame': 'Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up', 'description': 'Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.'}, {'measure': 'Change in status on Stroke Impact Scale', 'timeFrame': 'Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up', 'description': 'Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.'}], 'secondaryOutcomes': [{'measure': 'Brain structure', 'timeFrame': 'Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up', 'description': 'Structural MRI'}, {'measure': 'Brain Function', 'timeFrame': 'Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up', 'description': 'Brain functions related to sensory and motor systems assessed by MEG'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke', 'Upper Extremity Paresis']}, 'descriptionModule': {'briefSummary': 'Improving arm and hand function after stroke has been difficult to achieve within the rehabilitation service provided in the acute stage often due to the limited resource in health care. While spontaneous recovery plateaus after 6 months, the prolonged disability affects quality of life and social participation in stroke survivors. This study is aimed at improving chronic motor impairment arm and hand impairment by providing the intervention with intensive training schedule. This study will compare two types of rehabilitation intervention using a randomized controlled trial. Measurements also will be taken on various brain functions non-invasively to help discover how each of the intervention strategies works differently to repair the brain.', 'detailedDescription': 'After unilateral stroke, incomplete recovery of arm and hand movement is common and its long-lasting negative effects include increased care giving costs and overall reduced quality of life. Recent evidence suggests that a novel behavioral intervention could improve motor functions in sub-acute patients with added benefits in cognitive and brain functions. However few studies have addressed whether chronic stage patients can also benefit from the intervention and how brain plasticity works over the course of rehabilitation. This study will investigate the benefits of two types of intervention methods that are extendable for community-based intervention services in the future. It also will examine changes in integrity of motions before and after the intervention. Further comparisons between brain functions and structure will be made using magnetoencephalography (MEG) and magnetic resonance imaging (MRI), non-invasively. These behavioural and physiological measures will inform the mechanisms of stroke recovery and training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* post-acute stroke patients with unilateral first-time MCA stroke sustained . (more than 6 months ago prior to the enrolment to the study).\n* Patients' residual motor impairments in the affected hand and arm should be greater than stage 3 on the Chedoke McMaster scale.\n\nExclusion Criteria:\n\n* Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory loss in the paretic hand, severe language-communication disability, posture problems, involuntary movements, high-blood pressure, depression or other psychological disorders, metal in body that interferes with MEG and MRI measurements."}, 'identificationModule': {'nctId': 'NCT01721668', 'briefTitle': 'Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)', 'organization': {'class': 'OTHER', 'fullName': 'Baycrest'}, 'officialTitle': 'Examination of Therapeutic Intervention Methods on the Brain Recovery', 'orgStudyIdInfo': {'id': 'REB1213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSR - Music Supported Rehabilitation', 'description': 'Behavioral: Music Supported Rehabilitation', 'interventionNames': ['Behavioral: Music Supported Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CU/ET', 'description': 'Experimental: CU/ET (Conventional Upper Extremity Therapy)', 'interventionNames': ['Behavioral: Conventional Upper Extremity Therapy']}], 'interventions': [{'name': 'Music Supported Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.', 'armGroupLabels': ['MSR - Music Supported Rehabilitation']}, {'name': 'Conventional Upper Extremity Therapy', 'type': 'BEHAVIORAL', 'description': '-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.', 'armGroupLabels': ['CU/ET']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6A2E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Baycrest Centre for Geriatric Care', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Deirdre R Dawson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baycrest'}, {'name': 'Bernhard Ross, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baycrest'}, {'name': 'Takako Fujioka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baycrest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute', 'investigatorFullName': 'Dr. Deirdre Dawson', 'investigatorAffiliation': 'Baycrest'}}}}