Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-28 @ 11:31 AM
Study NCT ID:
NCT01815905
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of U-Health Service in Stroke Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013070', 'term': 'Speech Therapy'}], 'ancestors': [{'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EuroQol(EQ-5D)', 'timeFrame': '4weeks', 'description': 'measurement of health outcome'}], 'primaryOutcomes': [{'measure': 'Fugl-Meyer upper extremity scale', 'timeFrame': '4weeks', 'description': 'upper extremity function test'}, {'measure': 'short form K-FAST (Korean version of Frenchay Aphasia Screening)', 'timeFrame': '4weeks', 'description': 'speech function screening test'}], 'secondaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': '4weeks', 'description': 'hand power measurement'}, {'measure': 'K-WAB(Korean version-the Western Aphasia Battery)', 'timeFrame': '4weeks', 'description': 'speech evaluation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Provides mobile programs for occupational and speech therapy to patients with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke confirmed by brain imaging study\n* Impairment in upper extremity function or speech\n* native speaker of Korean\n\nExclusion Criteria:\n\n* previous history of aphasia\n* psychiatric or psychotic problem\n* severe cognitive dysfunction\n* severe hearing or visual loss\n* cannot sit with devices'}, 'identificationModule': {'nctId': 'NCT01815905', 'briefTitle': 'Effect of U-Health Service in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia', 'orgStudyIdInfo': {'id': 'B-1206/160-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional therapy', 'description': 'Traditional rehabilitation therapy', 'interventionNames': ['Other: Traditional rehabilitation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile program', 'description': 'Mobile program for occupational and speech therapy', 'interventionNames': ['Other: Mobile program for occupational and speech therapy']}], 'interventions': [{'name': 'Mobile program for occupational and speech therapy', 'type': 'OTHER', 'armGroupLabels': ['Mobile program']}, {'name': 'Traditional rehabilitation therapy', 'type': 'OTHER', 'armGroupLabels': ['Traditional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Nam-Jong Paik, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'KT Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nam-Jong Paik', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}