Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00832351
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Akershus Early Mobilisation in Stroke Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'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': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome', 'timeFrame': '3 month'}], 'secondaryOutcomes': [{'measure': 'Neurological deficits', 'timeFrame': '3 month', 'description': 'NIHSS'}, {'measure': 'Morbidity', 'timeFrame': '3 month'}, {'measure': 'Complications', 'timeFrame': '3 month'}, {'measure': 'Cognitive function', 'timeFrame': '3 month', 'description': 'MMSE'}, {'measure': 'Emotional function', 'timeFrame': '3 month', 'description': 'HAD'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Brain infarction', 'Intracerebral hemorrhage', 'Early Mobilisation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Treatment in stroke units compared with treatment in general medical wards reduces the odds of being dead or disabled. Little is known about which components of acute stroke care that is responsible for this benefit.\n\nEarly mobilisation is one of the features of stroke unit care. In Scandinavia, any intervention aimed to reduce the time to the first out of bed episode has been focused in order to prevent complications.\n\nHowever, therapeutic interventions for cerebral revascularisation and a more intensive unit approach for observation may postpone mobilisation. The aim of the present study is to identify whether early mobilisation (\\< 24 hours after admittance to hospital)reduce disability and mortality compared with mobilisation after 24 hours.\n\nThe study is a prospective, randomised controlled study with blinded assessment at the end of follow up. Patients admitted to the Stroke Unit, Akershus University Hospital less than 24 hours after stroke during 2009 - 2011 are screened for recruitment. Patients are randomly assigned to either mobilisation out of bed within 24 hours from admittance to hospital or mobilisation after 24 hours. Except early contra late mobilisation all patients receive standard stroke unit care.\n\nPatients with modified Rankin Scale 0 and 1, patients with a secondary intracerebral hemorrhage, patients receiving thrombolysis or patients requiring palliative care are excluded.\n\nAll patients are assessed at admittance, discharge and 3 months poststroke. Investigations at admittance include standard blood sample, CT/MRI scan, EKG and ultrasound of carotid arteries.\n\nMain outcome is mortality and disability 3 months poststroke. Secondary outcome measures are neurological deficits (NIH), morbidity, complications, cognitive function reflected by Mini Mental State Examination and emotional function (Hospital Anxiety and Depression scale) .\n\nResults from this study may add important knowledge about how and when to start mobilisation of patients with acute stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)\n\nExclusion Criteria:\n\n* admitted to hospital more than 24 hours after stroke onset\n* mRS 0 and 1\n* mRS 5\n* patients requiring palliative care\n* secondary/traumatic intracerebral hemorrhage\n* pregnancy\n* i.v./i.a. thrombolysis'}, 'identificationModule': {'nctId': 'NCT00832351', 'acronym': 'AKEMIS', 'briefTitle': 'Akershus Early Mobilisation in Stroke Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome', 'orgStudyIdInfo': {'id': '1.2006.322 (REK)'}, 'secondaryIdInfos': [{'id': '04/01666-22 (NSD)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Early mobilisation within 24 hours after admittance to hospital', 'interventionNames': ['Procedure: Mobilisation']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Mobilisation after 24 but within 48 hours from admittance to hospital'}], 'interventions': [{'name': 'Mobilisation', 'type': 'PROCEDURE', 'description': 'Mobilisation', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Department of Neurology, Akershus University Hospital'}], 'overallOfficials': [{'name': 'Ole Morten Rønning, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neurology, Akershus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antje Sundseth', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}