Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-17 @ 1:00 AM
Study NCT ID:
NCT02292251
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2014-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Enhance Motor Acute Recovery With Intensive Training After 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2014-11-08', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Upper Extremity (FM-UE)', 'timeFrame': 'from baseline to day 3 post-training', 'description': 'Change in arm impairment, measured by FM-UE'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer Upper Extremity (FM-UE)', 'timeFrame': 'from baseline to day 90 post-training', 'description': 'Change in arm impairment, measured by FM-UE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Transcranial direct current stimulation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '33745372', 'type': 'DERIVED', 'citation': 'Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.'}, {'pmid': '33175411', 'type': 'DERIVED', 'citation': 'Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age over 21 years\n2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks\n3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)\n4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.\n5. Ability to give informed consent and understand the tasks involved.\n\nExclusion Criteria:\n\n1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.\n2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.\n3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.\n4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.\n5. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).\n6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.\n7. Participation in another upper extremity rehabilitative therapy study during the study period.\n8. Terminal illness\n9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments."}, 'identificationModule': {'nctId': 'NCT02292251', 'acronym': 'SMARTS2', 'briefTitle': 'Study to Enhance Motor Acute Recovery With Intensive Training After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Study to Enhance Motor Acute Recovery With Intensive Training After Stroke', 'orgStudyIdInfo': {'id': 'IRB00047647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Device-assisted therapy', 'description': '30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation', 'interventionNames': ['Behavioral: Device-assisted therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapy-based occupational therapy', 'description': '30 hours of conventional occupational therapy that emphasizes task-oriented training.', 'interventionNames': ['Behavioral: Therapy-based occupational therapy']}], 'interventions': [{'name': 'Device-assisted therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Device-assisted therapy']}, {'name': 'Therapy-based occupational therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Therapy-based occupational therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'John W. Krakauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'James S McDonnell Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}