Stroke SequelaeFAIWHCNCT04285957
Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke
An observational study of Stroke Sequelae, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Questionnaire administration pre test and Questionnaire administration - validation
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2020to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. Validation: 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
Who may be able to join
- age 18-90;
- 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).
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- 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.
Who cannot join
- 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
- Validation: recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Italian Translation and Transcultural Validation of Two Assessment Tools for Participation in Stroke Survivors: the Frenchay Activity Index and the Walking Handicap Classification (FAIWHC)
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.
Read the detailed description
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
- Conditions
- Stroke Sequelae
- Being tested
- Questionnaire administration pre test, Questionnaire administration - validation
- Keywords
- participation, Frenchay Activity Index, Walking Handicap Classification, Stroke Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administration pre testOther
Also called Questionnaire administration - validation
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 - validationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire administration pre test | |
| 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 Receives: Other: Questionnaire administration - validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater reliability
Intraclass Correlation Coefficient >=0,70
Measured: 1 year
Internal consistency (FAI)
Cronbach's alpha>=0,70
Measured: 1 year
concurrent validity of FAI against SIP
Spearman's coefficient >=0.25-0.50
Measured: 1 year
concurrent validity of WHC against RMI
Spearman's coefficient >=0.25-0.50
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start15 Sep 2020
- Primary completion14 Sep 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Cecchi, Md, Principal investigator, Fondazione don Carlo Gnocchi IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285957
- Sponsor's protocol ID
- FAIWHC
- Acronym
- FAIWHC
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2020
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Translation and Transcultural Validation of Two Assessment Tools for Participation in Stroke Survivors: the Frenchay Activity Index and the Walking Handicap Classification (FAIWHC)
- ClinicalTrials.gov ID
- NCT04285957
- Acronym / sponsor ID
- FAIWHC / FAIWHC
- Conditions
- Stroke Sequelae
- Keywords
- participation, Frenchay Activity Index, Walking Handicap Classification, Stroke Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-test Group | – | Other: Questionnaire administration pre testConsecutive 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 |
| Validation Group | – | Other: Questionnaire administration - validationRecruitment 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. Validation: 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
Key inclusion criteria (9 listed)
- age 18-90;
- stroke occurred within 3 months from enrollment;
- clinical stability (SIC = 0).
- age 18-90,
- stroke occurred within 8 months from enrollment;
Key exclusion criteria (4 listed)
- 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
- Validation: recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administration pre testAlso: Questionnaire administration - validationPre-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); | Other | pre-test Group |
| Questionnaire administration - validationValidation 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 | Validation Group |
Primary outcome
Interrater reliability
Time frame: 1 year
Intraclass Correlation Coefficient >=0,70
Internal consistency (FAI)
Time frame: 1 year
Cronbach's alpha>=0,70
concurrent validity of FAI against SIP
Time frame: 1 year
Spearman's coefficient >=0.25-0.50
concurrent validity of WHC against RMI
Time frame: 1 year
Spearman's coefficient >=0.25-0.50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Cecchi, Md principal investigator
Fondazione don Carlo Gnocchi IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Sequelae, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater reliability (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.