Clinical trial NCT04285957: Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Sequelae
Keywords: participation
Frenchay Activity Index
Walking Handicap Classification
Stroke Rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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

Eligibility criteria: Pre-test: 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).

Exclusion criteria:

* 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-

Inclusion criteria:

* 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.

Primary outcomes:
measure: Interrater reliability
timeFrame: 1 year
measure: Internal consistency (FAI)
timeFrame: 1 year
measure: concurrent validity of FAI against SIP
timeFrame: 1 year
measure: concurrent validity of WHC against RMI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione don Gnocchi
Study officials:
affiliation: Fondazione don Carlo Gnocchi IRCCS
name: Francesca Cecchi, Md
role: PRINCIPAL_INVESTIGATOR
References: