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Completed

NCT Number: NCT04285957

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

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.

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Key information

Conditions

Stroke Sequelae

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione don Gnocchi

Florence, 50143, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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);

Other names: Questionnaire administration - validation

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)

Primary outcomes

  1. Interrater reliability

    Time frame: 1 year

    Intraclass Correlation Coefficient >=0,70

  2. Internal consistency (FAI)

    Time frame: 1 year

    Cronbach's alpha>=0,70

  3. concurrent validity of FAI against SIP

    Time frame: 1 year

    Spearman's coefficient >=0.25-0.50

  4. concurrent validity of WHC against RMI

    Time frame: 1 year

    Spearman's coefficient >=0.25-0.50

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study 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)

Acronym: FAIWHC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2020
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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