Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke
NCT ID: NCT04285957
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2020-09-15
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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pre-test Group
Consecutive recruitment of 10 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 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
Questionnaire administration pre test
Pre-test:
Two 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);
Validation Group
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
Questionnaire administration - validation
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)
Interventions
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Questionnaire administration pre test
Pre-test:
Two 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);
Questionnaire administration - validation
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* stroke occurred within 3 months from enrollment;
* clinical stability (SIC = 0).
* age 18-90,
* stroke occurred within 8 months from enrollment;
* clinical stability (SIC = 0).
Criteria for carrying out the interview with a proxy. If a proxy is not available, the patient is excluded:
* 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.
Exclusion Criteria
* 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
Validation: recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute-
18 Years
90 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Francesca Cecchi, Md
Role: PRINCIPAL_INVESTIGATOR
Fondazione don Carlo Gnocchi IRCCS
Locations
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Fondazione don Gnocchi
Florence, , Italy
Countries
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Other Identifiers
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FAIWHC
Identifier Type: -
Identifier Source: org_study_id
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