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

Stroke Sequelae Clinical Trial

— FAIWHC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04285957
• Other study ID #: FAIWHC
• Status: Not yet recruiting
• Start date: September 15, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: February 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Chiara Castagnoli, pt
• Phone: 05573931
• Email: ccastagnoli[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 15, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

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);
• 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)

Locations

Country	Name	City	State
Italy	Fondazione don Gnocchi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

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