Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT02592759
Status:
TERMINATED
Last Update Posted:
2019-10-01
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'The trial was prematurely terminated due to slow recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-28', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment of Upper Extremity change', 'timeFrame': 'Change from baseline points at 2 weeks and 6 weeks', 'description': 'Evaluation tool for upper extremity function'}], 'secondaryOutcomes': [{'measure': 'Brunnström stage change', 'timeFrame': 'Change from baseline stage at 2 weeks and 6 weeks', 'description': 'Evaluation tool for recovery'}, {'measure': 'Modified Barthel Index change', 'timeFrame': 'Change from baseline points at 2 weeks and 6 weeks', 'description': 'Evaluation tool for the level of active daily living'}, {'measure': 'Care Burden Scale change', 'timeFrame': 'Change from baseline points at 2 weeks and 6 weeks', 'description': 'Evaluation tool to measure the care burden'}, {'measure': 'Hand power change', 'timeFrame': 'Change from baseline power at 2 weeks and 6 weeks', 'description': 'Hand power using hand-held dynamometer'}, {'measure': 'Jebsen Hand function Test change', 'timeFrame': 'Change from baseline points at 2 weeks and 6 weeks', 'description': 'Evaluation tool for upper extremity function'}, {'measure': 'Box and Block Test change', 'timeFrame': 'Change from baseline points at 2 weeks and 6 weeks', 'description': 'Evaluation tool for upper extremity function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke', 'Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '33240205', 'type': 'DERIVED', 'citation': 'Kang MG, Yun SJ, Lee SY, Oh BM, Lee HH, Lee SU, Seo HG. Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial. Front Neurol. 2020 Nov 9;11:580393. doi: 10.3389/fneur.2020.580393. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.', 'detailedDescription': 'This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)\n* 72 hours \\~ 3 months after stroke\n* Upper extremity hemiplegia with Brunnström stage 2-5.\n* The patients can sit to receive treatment for at least 1 hour\n\nExclusion Criteria:\n\n* The patients cannot perform occupational treatments because of severe hemineglect or hemianopia\n* Contracture due to severe limitation of motion\n* Upper extremity spasticity in the wrist and fingers with modified Ashworth scale \\> 2 points\n* Fugl-Meyer Assessment-Wrist \\& Hand score \\>= 21 points\n* moderate to severe cognitive dysfunction \\< MMSE 18 points\n* Severe aphasia\n* The patients who has been diagnosed as malignant tumor'}, 'identificationModule': {'nctId': 'NCT02592759', 'briefTitle': 'Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke', 'orgStudyIdInfo': {'id': '16-2015-74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart Glove Group', 'description': 'The subjects will be treated with conventional occupational therapy for 30 minutes and smart glove treatment for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.', 'interventionNames': ['Device: Smart Glove Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Homework group', 'description': 'The subjects will be treated with conventional occupational therapy for 30 minutes and upper extremity rehabilitation homework which means the self training at bedside, for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.'}], 'interventions': [{'name': 'Smart Glove Treatment', 'type': 'DEVICE', 'description': 'Smart glove is digital motion-based treatment device for stroke rehabilitation. The stroke patients wear this glove and hand motion is displayed on the computer monitor. They play games with this glove and are motivated to rehabilitation treatment because of fun.', 'armGroupLabels': ['Smart Glove Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Shi-Uk Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shi-Uk Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}