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Clinical Trials/NCT04285957
NCT04285957
Completed
N/A

Italian Translation and Transcultural Validation of Two Assessment Tools for Participation in Stroke Survivors: the Frenchay Activity Index and the Walking Handicap Classification (FAIWHC)

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country70 target enrollmentSeptember 15, 2020
ConditionsStroke Sequelae

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke Sequelae
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
70
Locations
1
Primary Endpoint
Internal consistency (FAI)
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
November 15, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Internal consistency (FAI)

Time Frame: 1 year

Cronbach's alpha\>=0,70

Interrater reliability

Time Frame: 1 year

Intraclass Correlation Coefficient \>=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

Study Sites (1)

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