Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-11 @ 2:23 AM
Study NCT ID:
NCT03698357
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Balance-based Exercise in Persons With 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Berg Balance Scale (BBS)', 'timeFrame': 'Measurement before and after intervention ( week 0 and at the end of week 4) in both groups', 'description': 'Participants perform a series of 14 functional balance tasks, such as maintaining a quiet stance, sitting-to-stand, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.'}], 'secondaryOutcomes': [{'measure': 'Change of Time Up Go test (TUG)', 'timeFrame': 'Measurement before and after intervention ( week 0 and at the end of week 4) in both groups', 'description': 'The TUG test is a quick, reliable, valid, and accurate method commonly used to test dynamic stability and functional mobility. In the test, participants stand up from a 46-cm-high armchair with back support, walk straight for 3 m, turn around, walk back to the chair, and sit down as quickly and safely as possible.'}, {'measure': 'Change of Modified Falls Efficacy Scale (MFES)', 'timeFrame': 'Measurement before and after intervention ( week 0 and at the end of week 4) in both groups', 'description': 'The MFES is a 14-item rating scale questionnaire that contains the original 10-activity Falls Efficacy Scale and 4 additional activities. It is used to assess confidence of not falling while performing daily activities.'}, {'measure': 'Change of Motricity Index (MI)', 'timeFrame': 'Measurement before and after intervention ( week 0 and at the end of week 4) in both groups', 'description': 'The MI reflects general muscle strength in persons with stroke.'}, {'measure': 'Change of Functional Ambulation Category (FAC)', 'timeFrame': 'Measurement before and after intervention ( week 0 and at the end of week 4) in both groups', 'description': 'The FAC is based on the required level of assistance during walking in individuals with stroke.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interactive video balance-based exercise', 'conventional physiotherapy'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '33902646', 'type': 'DERIVED', 'citation': 'Chen SC, Lin CH, Su SW, Chang YT, Lai CH. Feasibility and effect of interactive telerehabilitation on balance in individuals with chronic stroke: a pilot study. J Neuroeng Rehabil. 2021 Apr 26;18(1):71. doi: 10.1186/s12984-021-00866-8.'}]}, 'descriptionModule': {'briefSummary': 'This study is to compare the effects of Interactive video balance-based exercise (IVBE) intervention and conventional rehabilitation on the balance and functional performance in stroke survivors. Fifteen participants will receive Interactive video balance-based exercise, while the other half will receive conventional rehabilitation.', 'detailedDescription': 'Thirty individuals with stroke are recruited and allocated to 2 groups in this study. Fifteen participants in group A will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks. Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks. Time up go test (TUG), Berg Balance Scale (BBS), Modified Falls Efficacy Scale (MFES), Motricity Index (MI), Functional Ambulation Category (FAC) were assessed before and after intervention in both groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients present with unilateral hemiplegia caused by a first-ever stroke\n2. cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score\\>=23)\n3. medical and psychological condition stable\n\nExclusion Criteria:\n\n1. patients having severe spasticity (Modified Ashworth scale \\> 3)\n2. severe hearing or eye problem\n3. intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation"}, 'identificationModule': {'nctId': 'NCT03698357', 'briefTitle': 'Video Balance-based Exercise in Persons With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Hospital'}, 'officialTitle': 'Effect of Interactive Video Balance-based Exercise in Persons With Stroke', 'orgStudyIdInfo': {'id': 'N201708024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive video balance-based exercise', 'description': 'Fifteen participants in group A will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks.', 'interventionNames': ['Behavioral: interactive video balance-based exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional physiotherapy', 'description': 'Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks.', 'interventionNames': ['Behavioral: Conventional physiotherapy']}], 'interventions': [{'name': 'interactive video balance-based exercise', 'type': 'BEHAVIORAL', 'description': 'Interactive video balance-based exercise :10 minutes of warm up exercise, 30 minutes of Interactive video balance-based exercise and 5 minutes of cool down exercise.', 'armGroupLabels': ['Interactive video balance-based exercise']}, {'name': 'Conventional physiotherapy', 'type': 'BEHAVIORAL', 'description': 'conventional physiotherapy: 10 minutes of warm up exercise, 30 minutes conventional physiotherapy and 5 minutes of cool down exercise. Conventional physiotherapy contains rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on.', 'armGroupLabels': ['Conventional physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical university Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chien-Hung Lai, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lai chien hung', 'investigatorAffiliation': 'Taipei Medical University Hospital'}}}}