Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-04 @ 3:40 PM
Study NCT ID:
NCT02029651
Status:
UNKNOWN
Last Update Posted:
2015-04-14
First Post:
2014-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-14', 'releaseDate': '2016-02-16'}, {'resetDate': '2016-06-01', 'releaseDate': '2016-04-26'}], 'estimatedResultsFirstSubmitDate': '2016-02-16'}}, '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': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2014-01-01', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-meyer assessment_upper extremity', 'timeFrame': 'Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention'}], 'secondaryOutcomes': [{'measure': 'Fugl-meyer assessment_upper extremity', 'timeFrame': 'Baseline, after 10th intervention, after 20th intervention, 1 month after intervention'}, {'measure': 'Jebsen hand function test', 'timeFrame': 'Baseline, after 10th intervention, after 20th intervention, 1 month after intervention'}, {'measure': 'Purdue pegboard', 'timeFrame': 'Baseline, after 10th intervention, after 20th intervention, 1 month after intervention'}, {'measure': 'Stroke impact scale', 'timeFrame': 'Baseline, after 20th intervention'}, {'measure': 'Modified Ashworth scale of affected upper extremity', 'timeFrame': 'Baseline, after 20th intervention'}, {'measure': 'Medical research council scale of muscle strength of affected upper extremity', 'timeFrame': 'Baseline,after 20th intervention'}, {'measure': 'Satisfaction about intervention', 'timeFrame': 'after 20th intervention', 'description': 'only for the participants of E-glove intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Hand', 'Rehabilitation', 'Game'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '26911438', 'type': 'DERIVED', 'citation': 'Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegic stroke patients\n* Medical research council scale \\>= 2 of finger or wrist flexor/extensor\n* Medical research council scale \\>= 2 of elbow pronation/supination\n\nExclusion Criteria:\n\n* Bilateral weakness of upper extremities\n* Uncontrolled medical or surgical illness\n* Predisposing psychological or neurological disorders\n* Severe aphasia unable to communicate\n* Severe cognitive impairment not to cooperate\n* Severe pain impeding upper extremity rehabilitation'}, 'identificationModule': {'nctId': 'NCT02029651', 'briefTitle': 'Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Rehabilitation Center, Seoul, Korea'}, 'officialTitle': 'Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NRC-2013-04-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-glove system', 'description': 'E-glove rehabilitation system for upper extremity', 'interventionNames': ['Device: E-glove system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional occupational therapy', 'description': 'conventional occupational therapy', 'interventionNames': ['Procedure: Conventional occupational therapy']}], 'interventions': [{'name': 'E-glove system', 'type': 'DEVICE', 'description': 'Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke', 'armGroupLabels': ['E-glove system']}, {'name': 'Conventional occupational therapy', 'type': 'PROCEDURE', 'description': 'conventional occupational therapy', 'armGroupLabels': ['Conventional occupational therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '142884', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joon-Ho Shin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Rehabilitation Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Trade, Industry & Energy, Republic of Korea', 'class': 'OTHER_GOV'}, {'name': 'National IT Industry Promotion Agency, Republic of Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manager', 'investigatorFullName': 'Joon-Ho Shin', 'investigatorAffiliation': 'National Rehabilitation Center, Seoul, Korea'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-16', 'type': 'RELEASE'}, {'date': '2016-03-14', 'type': 'RESET'}, {'date': '2016-04-26', 'type': 'RELEASE'}, {'date': '2016-06-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Joon-Ho Shin, Manager, National Rehabilitation Center, Seoul, Korea'}}}}