Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT00849303
Status:
UNKNOWN
Last Update Posted:
2009-02-23
First Post:
2009-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Rehabilitation Study in Acute 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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-20', 'studyFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2009-02-20', 'lastUpdatePostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ambulatory Category', 'timeFrame': '4 measures during six months'}, {'measure': 'Barthel Index', 'timeFrame': '4 measures during 6 months'}], 'secondaryOutcomes': [{'measure': "10 meters's walking speed", 'timeFrame': '4 measures during 6 months'}, {'measure': "6 minutes' walking distance", 'timeFrame': '4 measures during 6 months'}, {'measure': 'Berg Balance Scale', 'timeFrame': '4 measures during 6 months'}, {'measure': 'Functional Status Questionnaire', 'timeFrame': '4 measures during 6 months'}, {'measure': 'Geriatric Depression Scale -15', 'timeFrame': '4 measures during 6 months'}, {'measure': 'Beck Depression Intervention modified by Raitasalo', 'timeFrame': '4 measures during 6 months'}, {'measure': 'Modified Motor Assessment Scale', 'timeFrame': '4 measures during 6 months'}, {'measure': 'Postural sway by Good Balance', 'timeFrame': '3-4 measures during 6 months'}, {'measure': 'spatio-temporal gait analysis by GaitRite', 'timeFrame': '3-4 measures during 6 months'}, {'measure': 'WHOQOF-BREF', 'timeFrame': "at end and at 6 months' follow-up"}, {'measure': 'TMS responses (MT,MEPs,SP,SICI)', 'timeFrame': '4 measures during 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'rehabilitation', 'gait', 'timing', 'transcranial magnetic stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2)\n* time since onset of stroke no more than 10 days\n* Functional Ambulatory Category (FAC) 0-3\n* voluntary movement in the leg of the affected side\n* Barthel Index (BI) 25-75 points- no unstable cardiovascular disease\n* Body Mass Index (BMI) \\<32\n* no severe malposition of joints\n* no severe cognitive or communicative disorders\n* no other health-related or social barriers to participate intensive rehabilitation\n\nExclusion Criteria:\n\n* ICH, or MRS \\>2\n* time since onset of stroke more than 10 days\n* FAC \\>3\n* no voluntary movement in the leg of the affected side\n* BI \\<25 or \\>75\n* severe malposition of joints\n* severe cognitive or communicative disorders'}, 'identificationModule': {'nctId': 'NCT00849303', 'briefTitle': 'Multicenter Rehabilitation Study in Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Jyvaskyla'}, 'officialTitle': 'Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '5772765'}, 'secondaryIdInfos': [{'id': 'Academy of Finland 114291'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'earlier gait-oriented rehabilitation', 'description': 'Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.', 'interventionNames': ['Other: gait-oriented rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'later gait-oriented rehabilitation', 'description': 'Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.', 'interventionNames': ['Other: gait-oriented rehabilitation']}], 'interventions': [{'name': 'gait-oriented rehabilitation', 'type': 'OTHER', 'description': 'Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts within 10 days since stroke onset.', 'armGroupLabels': ['earlier gait-oriented rehabilitation']}, {'name': 'gait-oriented rehabilitation', 'type': 'OTHER', 'description': 'Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts five weeks after stroke onset.', 'armGroupLabels': ['later gait-oriented rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Jyväskylä', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'facility': 'Middle Finland central hospital and Kinkomaa hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '70211', 'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '71130', 'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'facility': 'Brain Research and Rehabilitation Center Neuron', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '33520', 'city': 'Tampere', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'facility': 'Tampere university hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Sinikka H Peurala, PhD, PT', 'role': 'CONTACT', 'email': 'sinikka.h.peurala@jyu.fi', 'phone': '+358 14 260 2196'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jyvaskyla', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northern Savo Hospital District', 'class': 'OTHER'}, {'name': 'Academy of Finland', 'class': 'OTHER'}, {'name': 'Brain Research and Rehabilitation Center Neuron (grant # 1/2009)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Sinikka H Peurala, Post doctoral researcher', 'oldOrganization': 'University of Jyväskylä/Department of Health Sciences/Finnish Centre for Interdisciplinary Gerontology'}}}}