Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 12:21 PM
Study NCT ID:
NCT01694992
Status:
UNKNOWN
Last Update Posted:
2012-09-27
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Early Rehabilitation in Acute Ischemic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-09-25', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability', 'timeFrame': 'three months', 'description': 'Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.'}], 'secondaryOutcomes': [{'measure': 'Minimum or no Disability', 'timeFrame': 'three months', 'description': 'Measured by the modified Ranking Scale with score of 0 to 1.'}, {'measure': 'Independence in activities of daily living', 'timeFrame': 'three months', 'description': 'Measured by the modified Barthel Index, where score \\< 75 indicate dependence and score \\> 75 is independence.'}, {'measure': 'Long of stay at hospital', 'timeFrame': 'three month', 'description': 'Number of days in hospital'}, {'measure': 'Death', 'timeFrame': 'three month', 'description': 'Determined by a blinded review of the clinical details by the investigators.'}, {'measure': 'Incidence of complications', 'timeFrame': 'three month', 'description': 'Number of complications (pneumonia and deep vein thrombosis) at three month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Early Ambulation', 'Rehabilitation', 'Physical Therapy', 'Randomized controlled trial'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34695300', 'type': 'DERIVED', 'citation': 'Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first 48 hours of onset of symptoms.\n* Patients older than 18 years.\n* Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and RR below 25 bpm).\n* Patients are able to react to verbal commands even without being fully alert (Glasgow Scale above 8).\n* Prior Rankin until 3\n* Motor deficit and / or coordination measured by the NIHSS\n\nExclusion Criteria:\n\n* Patients with clinical and / or hemodynamic instability\n* Patients with hemorrhagic stroke or TIA (transient ischemic attack).\n* Patients with progressive neurological disease and acute coronary disease and / or unstable.'}, 'identificationModule': {'nctId': 'NCT01694992', 'acronym': 'VERIS-Brazil', 'briefTitle': 'Very Early Rehabilitation in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA', 'orgStudyIdInfo': {'id': '11.0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early mobilization', 'description': 'The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).', 'interventionNames': ['Other: Early mobilization']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The Control Group will follow within the routines of the hospital as is usually done.'}], 'interventions': [{'name': 'Early mobilization', 'type': 'OTHER', 'otherNames': ['Early Physiotherapy Program'], 'description': 'The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).', 'armGroupLabels': ['Early mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Simone RP Gobbato, Physiotherapist', 'role': 'CONTACT', 'email': 'sissipoletto@hotmail.com', 'phone': '55 51 9982 3387'}, {'name': 'Sheila CO Martins, Physician', 'role': 'CONTACT', 'email': 'scmartins@hcpa.ufrgs.br', 'phone': '55 51 9962 8467'}, {'name': 'Simone RP Gobbato, Physiotherapist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre (Hospital)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Simone RP Gobbato, Physiotherapist', 'role': 'CONTACT', 'email': 'sissipoletto@hotmail.com', 'phone': '55 51 9982 3387'}, {'name': 'Sheila CO Martins, Physician', 'role': 'CONTACT', 'email': 'scmartins@hcpa.ufrgs.br', 'phone': '55 51 9962 8467'}], 'overallOfficials': [{'name': 'Sheila CO Martins, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre (Hospital)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}