Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-05 @ 12:58 PM
Study NCT ID:
NCT03282734
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2017-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Exercise Program With Smart Rehabilitation System
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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2017-09-10', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go test', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of balance and gait function'}], 'secondaryOutcomes': [{'measure': 'Tinetti Performance Oriented Mobility Assessment', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of balance and gait function'}, {'measure': 'Berg Balance scale', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of balance'}, {'measure': 'Korean-Geriatric Depression Scale- Short Form', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of mood'}, {'measure': 'EQ-5D', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of quality of life'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of fall risk'}, {'measure': 'Korean version of Physical Activity Scale for the Elderly', 'timeFrame': 'Change from baseline Timed Up and Go test at 4 weeks', 'description': 'Assessment of physical activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.', 'detailedDescription': 'The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult stroke patients (more than 18 years old)\n* less than 6 months after stroke onset\n* discharged to home or the plan to discharge to home less than 3 days\n* independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)\n\nExclusion Criteria:\n\n* Advanced liver, kidney, cardiac, or pulmonary disease\n* A terminal medical diagnosis consistent with survival \\< 1 year)\n* Pre-existing and active major neurological disease\n* Pre-existing and active major psychiatric disease\n* Severe language disorders\n* Severe cognitive disorders (10 or less than 10 in K-MMSE)'}, 'identificationModule': {'nctId': 'NCT03282734', 'acronym': 'Smart-Rehab', 'briefTitle': 'Home-based Exercise Program With Smart Rehabilitation System', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients', 'orgStudyIdInfo': {'id': '2017-07-072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The smart rehab group', 'description': 'Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks', 'interventionNames': ['Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'Conventional home rehabilitation exercise education for 4 weeks', 'interventionNames': ['Other: Conventional home rehabilitation exercise']}], 'interventions': [{'name': 'Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)', 'type': 'OTHER', 'description': 'Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks', 'armGroupLabels': ['The smart rehab group']}, {'name': 'Conventional home rehabilitation exercise', 'type': 'OTHER', 'description': 'Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks', 'armGroupLabels': ['The control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Won Hyuk Chang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}