Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT04285957
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interrater reliability', 'timeFrame': '1 year', 'description': 'Intraclass Correlation Coefficient \\>=0,70'}, {'measure': 'Internal consistency (FAI)', 'timeFrame': '1 year', 'description': "Cronbach's alpha\\>=0,70"}, {'measure': 'concurrent validity of FAI against SIP', 'timeFrame': '1 year', 'description': "Spearman's coefficient \\>=0.25-0.50"}, {'measure': 'concurrent validity of WHC against RMI', 'timeFrame': '1 year', 'description': "Spearman's coefficient \\>=0.25-0.50"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['participation', 'Frenchay Activity Index', 'Walking Handicap Classification', 'Stroke Rehabilitation'], 'conditions': ['Stroke Sequelae']}, 'descriptionModule': {'briefSummary': 'This study is aimed at providing an Italian version of two assessment tools for participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC) by a standardized translation and transcultural validation protocol. The protocol includes a pre-test of the Italian version on ten patients, a final revision, and a validation on a sample of 60 stroke patients.', 'detailedDescription': 'This study is aimed at providing an Italian version of two tools to assess participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC). These tools have been recently indicated for the assessment of participation in Stroke patients by the Italian Association of Physical and Rehabilitation Medicine (Minimal Stroke Assessment Protocol - PMIC2); they are currently used in Italian research and clinical settings, but no official translation exists. The process requires a standardized translation protocol, including forward and backward translation, using a multistep revision structure, to ensure conceptual and semantic equivalence. The validation process includes a pilot evaluation of on 10 individuals post-stroke admitted to the Neurological Rehabilitation Unit, Foundation Don Gnocchi Scientific Institute, and a validation on a sample of 60 stroke patients including reliability, internal consistency and concurrent validity assessment of the translated version against the Sickness Impact Profile (SIP) - Italian version and the Rivermead Mobility Index (RMI) - Italian version, respectively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pre-test: 10 consecutively recruited post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute.Inclusion and exclusion criteria listed in the dedicated section.\n\nValidation: 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institue.Inclusion and exclusion criteria listed in the dedicated section. If the following are present: visual and / or hearing disorders; cognitive decline (MMSE \\<21) and/or severe aphasia, which would limit the patients' understanding of and the reliable answering to the two assessment tools, the interview shall be carried out with a proxy", 'healthyVolunteers': False, 'eligibilityCriteria': "Pre-test: consecutive recruitment of 10 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute.\n\nInclusion criteria:\n\n* age 18-90;\n* stroke occurred within 3 months from enrollment;\n* clinical stability (SIC = 0).\n\nExclusion criteria:\n\n* stroke recurrence;\n* visual and / or hearing disorders;\n* cognitive decline (MMSE \\<21) and/or severe aphasia, which would limit the the patients' understanding of and the reliable answering to the two assessment tools\n\nValidation: recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute-\n\nInclusion criteria:\n\n* age 18-90,\n* stroke occurred within 8 months from enrollment;\n* clinical stability (SIC = 0).\n\nCriteria for carrying out the interview with a proxy. If a proxy is not available, the patient is excluded:\n\n* visual and / or hearing disorders;\n* cognitive decline (MMSE \\<21) and/or severe aphasia, which would limit the patients' understanding of and the reliable answering to the two assessment tools."}, 'identificationModule': {'nctId': 'NCT04285957', 'acronym': 'FAIWHC', 'briefTitle': 'Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Italian Translation and Transcultural Validation of Two Assessment Tools for Participation in Stroke Survivors: the Frenchay Activity Index and the Walking Handicap Classification (FAIWHC)', 'orgStudyIdInfo': {'id': 'FAIWHC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-test Group', 'description': "Consecutive recruitment of 10 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute.\n\nInclusion criteria: age 18-90, stroke occurred within 3 months from enrollment; clinical stability (SIC = 0). The exclusion criteria are: stroke recurrence; visual and / or hearing disorders; cognitive decline (MMSE \\<21) and/or severe aphasia, which would limit the the patients' understanding of and the reliable answering to the two assessment tools", 'interventionNames': ['Other: Questionnaire administration pre test']}, {'label': 'Validation Group', 'description': "Recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute.Inclusion criteria: age 18-90, stroke occurred within 8 months from enrollment; clinical stability (SIC = 0). If the following criteria are present: visual and / or hearing disorders; cognitive decline (MMSE \\<21) and/or severe aphasia, which would limit the patients' understanding of and the reliable answering to the two assessment tools, the interview shall be carried out with a proxy", 'interventionNames': ['Other: Questionnaire administration - validation']}], 'interventions': [{'name': 'Questionnaire administration pre test', 'type': 'OTHER', 'otherNames': ['Questionnaire administration - validation'], 'description': 'Pre-test:\n\nTwo expert physicians/physical therapist shall be involved in the questionnaire administration (A/B). The questionnaires shall be randomly administered to the patients by one operator at T0 the same test shall be readministered after 1-2 weeks by another operator (T1), blind to the first assessment; the second operator shall also administer the additional measures (SIP and RMI);', 'armGroupLabels': ['pre-test Group']}, {'name': 'Questionnaire administration - validation', 'type': 'OTHER', 'description': 'Validation Two expert physicians shall be involved in the questionnaire administration (A/B). The questionnaires shall be randomly administered to the patients by one operator at T0 the same test shall be readministered after 1-2 weeks by another operator (T1), blind to the first assessment; the second operator shall also administer the additional measures (SIP and RMI); In case the patient is unable to be interviewed due to aphasia cognitive or sensorial problems, a proxy would be interviewed both at T0 and at T1 (the same proxy would be interviewed both times)', 'armGroupLabels': ['Validation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50143', 'city': 'Florence', 'country': 'Italy', 'facility': 'Fondazione don Gnocchi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Francesca Cecchi, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione don Carlo Gnocchi IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}