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

Completed

• Conditions: Stroke Sequelae

• Registration Number: NCT04285957
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Study Start: 2020-09-15
• Primary Completion: 2021-09-14
• Study Completion: 2021-11-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Internal consistency (FAI)	1 year	Cronbach's alpha\>=0,70
Interrater reliability	1 year	Intraclass Correlation Coefficient \>=0,70
concurrent validity of FAI against SIP	1 year	Spearman's coefficient \>=0.25-0.50
concurrent validity of WHC against RMI	1 year	Spearman's coefficient \>=0.25-0.50

Trial Locations

Locations (1)

Fondazione don Gnocchi; 🇮🇹 Florence, Italy