Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke (FAIWHC)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Stroke Sequelae

Treatments: Other: Questionnaire administration - validation; Other: Questionnaire administration pre test

Study type: Observational

Funder types: Other

Identifiers

NCT04285957

FAIWHC

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

70 participants in 2 patient groups

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. 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

Treatment:

Other: Questionnaire administration pre test

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

Treatment:

Other: Questionnaire administration - validation