Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT04399759
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2020-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Instrumental Activities of Daily Living Approach in Home Environment for Patients 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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.'}, {'measure': 'Balance computerized adaptive testing', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.'}, {'measure': 'Mini Mental State Examination', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.'}, {'measure': 'Participation Measure-3 Domains ,4 Dimensions', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.'}, {'measure': 'Canadian Occupational Performance Measure', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.'}, {'measure': 'Barthel Index (BI) -based Supplementary Scales', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.'}, {'measure': 'Frenchay Activities Index', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Frenchay Activities Index is a measure of instrumental activities of daily living for use with patients recovering from stroke. The score ranges is 0 to 45. A higher score indicates better instrumental activities of daily living.'}, {'measure': 'Lawnton Instrumental Activities of Daily Living', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Lawnton Instrumental Activities of Daily Living assesses instrumental activities of daily living.The score ranges is 0 to 8. A higher score indicates better instrumental activities of daily living.'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Stroke Impact Scale assesses other dimensions of health-related quality of life: emotion, communication, memory and thinking, and social role function.The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.'}, {'measure': 'Stroke Self-Efficacy Questionnaire', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.'}, {'measure': 'Kingston Caregiver Stress Scale', 'timeFrame': 'Baseline to 6 weeks', 'description': 'The Kingston Caregiver Stress Scale is a self-report scale measuring caregiver stress. The score ranges is 10 to 50. A higher score indicates greater stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Activities of Daily Living', 'Home Care Services'], 'conditions': ['Stroke', 'Activities of Daily Living']}, 'referencesModule': {'references': [{'pmid': '35349186', 'type': 'DERIVED', 'citation': 'Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study was to conduct a randomized clinical trial. Implement instrumental daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of A-IADL on stroke patients' movement, cognition, social participation, daily life function and quality of life.", 'detailedDescription': 'Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer Assessment, Balance computerized adaptive testing, Mini Mental State Examination, Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure, Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and Kingston Caregiver Stress Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 20 years\n* Diagnosis of stroke\n* The modified Rankin Scale : 2\\~4\n* Keep sitting for half an hour by himself/herself\n* Follow instructions\n* Willing to sign the subject's consent\n\nExclusion Criteria:\n\n* Diagnosis of dementia\n* History of orthopedic diseases or peripheral nerve injury"}, 'identificationModule': {'nctId': 'NCT04399759', 'briefTitle': 'Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke', 'orgStudyIdInfo': {'id': 'CTH-108-2-5-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-IADL Group', 'description': 'Approach-Instrumental Activities of Daily Living in home', 'interventionNames': ['Behavioral: Approach-Instrumental Activities of Daily Living']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Home health education', 'interventionNames': ['Behavioral: Home health education']}], 'interventions': [{'name': 'Approach-Instrumental Activities of Daily Living', 'type': 'BEHAVIORAL', 'description': 'Individualized instrumental activities of daily living training', 'armGroupLabels': ['A-IADL Group']}, {'name': 'Home health education', 'type': 'BEHAVIORAL', 'description': 'Individualized home health education', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '231403', 'city': 'New Taipei City', 'state': 'Xindian Dist', 'country': 'Taiwan', 'facility': 'Cardinal Tien Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'En-Chi Chiu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taipei University of Nursing and Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'En-Chi Chiu', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}