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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke Sequelae
• Intervention / Treatment: Other: Questionnaire administration pre test; Other: Questionnaire administration - validation

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Chiara Castagnoli, pt; Phone Number: 05573931; Email: ccastagnoli@dongnocchi.it
• Study Contact Backup: Name: Laura Antonucci, MD; Phone Number: 055793931; Email: lauraantonucci1@gmail.com

Study Locations

• Italy
  • Florence, Italy, 50143
    • Fondazione Don Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Questionnaire administration pre test; 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); Other Names: Questionnaire administration - validation
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	Other: Questionnaire administration - validation; 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Francesca Cecchi, Md, Fondazione Don Carlo Gnocchi IRCCS

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2020
• Primary Completion (Anticipated): September 14, 2021
• Study Completion (Anticipated): November 15, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Stroke Rehabilitation; participation; Frenchay Activity Index; Walking Handicap Classification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FAIWHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No