Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT03665220
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Two Home Ergonomics Programmes in Post-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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks", 'timeFrame': 'Twelve weeks', 'description': 'The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score \\<70 points was assigned.'}, {'measure': "Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks", 'timeFrame': 'Twenty four weeks', 'description': 'The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score \\<70 points was assigned.'}], 'secondaryOutcomes': [{'measure': 'Change from the Older Americans Resources and Services (OARS) scale at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.'}, {'measure': 'Change from the Older Americans Resources and Services (OARS) scale at 24 weeks', 'timeFrame': 'Twenty four weeks', 'description': 'Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.', 'detailedDescription': "For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke diagnosed 6-24 months previously\n* aged over 18 years\n* ability to speak and understand Portuguese.\n\nExclusion Criteria:\n\n* severe cognitive deficit\n* severe aphasia\n* other associated neurological disease\n* musculoskeletal pathology\n* drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT03665220', 'briefTitle': 'Effects of Two Home Ergonomics Programmes in Post-stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': "Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial", 'orgStudyIdInfo': {'id': 'Rehab in post-stroke patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ergonomic adjustment group', 'description': "Ergonomic intervention program at home for post-stroke patients. The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form.", 'interventionNames': ['Other: Ergonomic adjustments']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesiotherapy + ergonomics group', 'description': 'A Kinesiotherapy plus ergonomic adjustments program for post-stroke patients. This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).', 'interventionNames': ['Other: Kinesiotherapy plus ergonomic adjustments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthcare education', 'description': 'A conservative intervention program for post-stroke patients', 'interventionNames': ['Other: Healthcare education']}], 'interventions': [{'name': 'Ergonomic adjustments', 'type': 'OTHER', 'description': "The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form .", 'armGroupLabels': ['Ergonomic adjustment group']}, {'name': 'Kinesiotherapy plus ergonomic adjustments', 'type': 'OTHER', 'description': 'This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).', 'armGroupLabels': ['Kinesiotherapy + ergonomics group']}, {'name': 'Healthcare education', 'type': 'OTHER', 'description': 'This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.', 'armGroupLabels': ['Healthcare education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18007', 'city': 'Granada', 'country': 'Spain', 'facility': 'José Manuel Pérez Mármol', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'José Manuel Pérez Mármol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physiotherapy. Faculty of Health Sciences, University of Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'José Manuel Pérez Mármol', 'investigatorAffiliation': 'Universidad de Granada'}}}}