Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04054102
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2019-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute 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': ['PARTICIPANT'], 'maskingDescription': 'Participant does not know the allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of kinematic data during scale for the assessment and rating of ataxia', 'timeFrame': 'Change from baseline at 4 weeks after baseline', 'description': 'kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)'}], 'secondaryOutcomes': [{'measure': 'kinematic data during scale for the assessment', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline', 'description': 'kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)'}, {'measure': 'Fugl-Meyer Assessment - upper extremity', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline', 'description': 'indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment'}, {'measure': 'Wolf Motor Function Test', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline', 'description': 'an activity indicator, has 15 items for testing functional ability'}, {'measure': 'Motor activity log', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline', 'description': 'Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.'}, {'measure': 'Action reach arm test', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline', 'description': 'to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'transcranial direct current stimulation', 'upper extremity rehabilitation robot'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegic patients secondary to first cerebrovascular accidents\n* Onset ≤ 6 months\n* Fugl-Meyer Assessment score ≥ 19\n* Cognitively intact enough to understand and follow the instructions from the investigator\n\nExclusion Criteria:\n\n* Severe upper extremity pain that could interfere with rehabilitation therapy\n* Neurological disorders other than stroke that can cause motor deficits\n* Uncontrolled severe medical conditions.'}, 'identificationModule': {'nctId': 'NCT04054102', 'briefTitle': 'Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Rehabilitation Center, Seoul, Korea'}, 'officialTitle': 'Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Reaching Function of Upper Extremity Among Subjects With Subacute Stroke', 'orgStudyIdInfo': {'id': 'NRC-2018-01-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot and tDCS on-line', 'description': 'Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot', 'interventionNames': ['Other: Robot and tDCS on-line']}, {'type': 'SHAM_COMPARATOR', 'label': 'Robot and sham tDCS', 'description': 'Combined sham tDCS and upper extremity rehabilitation robot', 'interventionNames': ['Other: Robot and sham tDCS']}], 'interventions': [{'name': 'Robot and tDCS on-line', 'type': 'OTHER', 'otherNames': ['Robot used in this study is Armeo spring'], 'description': 'Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks', 'armGroupLabels': ['Robot and tDCS on-line']}, {'name': 'Robot and sham tDCS', 'type': 'OTHER', 'otherNames': ['Robot used in this study is Armeo spring'], 'description': 'Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks', 'armGroupLabels': ['Robot and sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '142884', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon-Ho Shin, MS', 'role': 'CONTACT'}, {'name': 'Joon-Ho Shin, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joon-Ho Shin, MS', 'role': 'CONTACT', 'email': 'asfreelyas@gmail.com', 'phone': '82-2-901-1884'}], 'overallOfficials': [{'name': 'Joon-Ho Shin, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Rehabilitation Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Team manager', 'investigatorFullName': 'Joon-Ho Shin', 'investigatorAffiliation': 'National Rehabilitation Center, Seoul, Korea'}}}}