Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-04-23 @ 11:25 AM
Study NCT ID:
NCT02718534
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2016-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071939', 'term': 'Stroke Rehabilitation'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-03', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was a favourable outcome at 3 months after stroke, measured with the Fugl-Meyer motor function score.', 'timeFrame': '90 days', 'description': 'Fugl-Meyer score'}], 'secondaryOutcomes': [{'measure': 'The primary outcome was a favourable outcome at 3 months after stroke, measured with Modified Rankin Scale score.', 'timeFrame': '90 days', 'description': 'Modified Rankin Scale score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Time of First Rehabilitation Therapy']}, 'referencesModule': {'references': [{'pmid': '25892679', 'type': 'BACKGROUND', 'citation': 'AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.'}, {'pmid': '33736542', 'type': 'DERIVED', 'citation': 'Wang F, Zhang S, Zhou F, Zhao M, Zhao H. Early physical rehabilitation therapy between 24 and 48 h following acute ischemic stroke onset: a randomized controlled trial. Disabil Rehabil. 2022 Jul;44(15):3967-3972. doi: 10.1080/09638288.2021.1897168. Epub 2021 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy took place within 48h with therapy took place after 48h for patients with stroke (modified Rankin Scale Score 3-4).', 'detailedDescription': 'Early rehabilitation after stroke is thought to contribute to the effects of stroke-unit care. However, time of initial rehabilitation therapy is poorly defined and not underpinned by strong evidence in patients with stroke (modified Rankin Scale Score 3-4). The investigators do this parallel-group, single-blind, randomized controlled trial in shengjing hospital of China Medical University. Participants (aged≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who meet physiological criteria are randomly assigned (1:1), to receive usual stroke therapy. Treatment with recombinant tissue plasminogen activator is allowed. Randomisation is stratified by study site and stroke severity. The primary outcome was a outcome 3 months after stroke, defined as a modified Rankin Scale score of 3-4. The investigators do analysis on an intention-to-treat basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients were diagnosed acute stroke within 24h onset. Head CT or MRI scans were confirmed the diagnosed.\n2. The age was from 18 to 75 years old.\n3. Temperature ≤38.0℃，Pulse rate 60-100bpm，Respiratory rate≤24 bpm，systolic blood pressure≤220mmHg.\n4. Glasgow score: 9-14.\n5. Acute Physiology and Chronic Health Evaluation(APACHE Ⅱ)score: ≤17.\n6. National Institutes of Health Stroke Scale (NIHSS)score: \\<16. (Upper and lower extremity motor function item score\\<8).\n7. Modified Rankin Scale score:3-4.\n8. There were no serious diseases before, such as heart, liver, kidney and lung diseases.\n9. Patients themselves or their nominated representative sign the informed consent form.\n\nExclusion Criteria:\n\n1. There were unstable vital sign. There were serious organic dysfunction (heart, liver, kidney or lung).\n2. Patients with transient ischemic attack.\n3. Patients with subarachnoid haemorrhage.\n4. Patients with haemorrhage were documented immediate surgery.\n5. Pregnancy patients with stroke.\n6. During the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).'}, 'identificationModule': {'nctId': 'NCT02718534', 'acronym': 'ERTAS', 'briefTitle': 'Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Effectiveness and Safeness of Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ERTAS'}, 'secondaryIdInfos': [{'id': 'LNCCC-D12-2015', 'type': 'OTHER_GRANT', 'domain': 'Health and family planning commission of Liaoning Province. China.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERTAS-1', 'description': 'first limb rehabilitation therapy took place within 48h for patients with acute stroke (modified Rankin Scale Score 3-4)', 'interventionNames': ['Behavioral: stroke rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERTAS-2', 'description': 'first limb rehabilitation therapy took place after 48h for patients with acute stroke (modified Rankin Scale Score 3-4)', 'interventionNames': ['Behavioral: stroke rehabilitation']}], 'interventions': [{'name': 'stroke rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Physical rehabilitation exercise between 24 and 48 hours and after 48 hours', 'armGroupLabels': ['ERTAS-1', 'ERTAS-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Hongyu Zhao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'deputy director of emergency department', 'investigatorFullName': 'Hongyu Zhao', 'investigatorAffiliation': 'Shengjing Hospital'}}}}