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

NCT04285957 | Completed

• 1 other identifier: FAIWHC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Keywords

participation; Frenchay Activity Index; Walking Handicap Classification; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

Questionnaire administration pre test OTHER

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);

Also known as: Questionnaire administration - validation

pre-test Group

Questionnaire administration - validation OTHER

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)

Validation Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age 18-90;
• stroke occurred within 3 months from enrollment;
• clinical stability (SIC = 0).

You may not qualify if:

• 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-
• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione don Gnocchi

Florence, 50143, Italy

Location

Study Officials

• Francesca Cecchi, Md

  Fondazione don Carlo Gnocchi IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 26, 2020
• Study Start: September 15, 2020
• Primary Completion: September 14, 2021
• Study Completion: November 15, 2021
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

IT (1)