Translation and Validation Fugl-Meyer in Italian Language

• Conditions: Validation Fugl Meyer Scale in Italian

• Registration Number: NCT03855618
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

The aim of the study is to carry out a transcultural translation of the Fugl-Meyer Assessment scale, both for the upper and lower limb, in Italian, and to perform a cultural validation of the translation on a group of post-stroke patients admitted to the SOR Neurological Foundation don Gnocchi ONLUS Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS).

As a research group the purpose is to translate the Fugl-Meyer Assessment scale into Italian in order to allow immediate clinical use.

Detailed Description

The Fugl-Meyer Assessment (FMA) is a specific instrument for evaluation of post-stroke patients. Introduced for the first time by Axl Fugl-Meyer and collaborators as a standardized assessment for hemiparetic patient and originally published in both English and Swedish. It represented the first quantitative assessment tool for the hemiplegic patient.

The FMA is a valid, reliable, responsive and most widely used standardized clinical scale for evaluation of the degree of sensory and motor impairment of the hemiplegic patient, and is considered to date one of the most used tools worldwide. Extensive research has shown that FMA is easy to use, does not require special equipment and has excellent validity, reliability and responsiveness, which makes this scale particularly suitable for different types of clinical settings around the world.

There are many currently translation and cultural validation studies in several languages (Danish, Norwegian, Spanish, French), but an official version validated in Italian is not available to date.

This study aims to perform and develop a transcultural validation of the FMA both for the upper and lower limbs in Italian, following a methodological approach already validated for the process of translation and cultural adaptation, including formal involvement with the University of Gothenburg, which holds the rights on the original scale.

The process of translation and cultural validation follows a standardized translation protocol, approved by the University of Goteborg which holds the rights on the official version of the scale in Swedish and in English. A phase of forward translation, revision and backward translation and final revision is planned to determine the conceptual, semantic and operational equivalence of the FMA scale.

A multistep structure is used for the revision and cultural and linguistic adaptation of the drafting.

The use of mother tongue translators, both English and Italian, and a interdisciplinary team of fiosterapists, physicians, speech therapists and neuropsychologists, with experience of Stroke rehabilitation in clinical and research fields, all employees or collaborators of IRCCS Don Carlo Gnocchi Foundation, which will review the translations.

The translated version in Italian is subsequently tested, through a pilot study, by three physiotherapists at SOR Neurological Foundation don Gnocchi ONLUS IRCCS, in order to identify lingual and conceptual inconsistencies that could influence the score, the understanding, the interpretation and the cultural equivalence of the scale.

Study Timeline

• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-02-24
• Study First Posted: 2019-02-27
• Study Start: 2019-03-15
• Primary Completion: 2019-07-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

consecutive 10 post-stroke patients in intensive rehabilitation treatment are expected, with an acute event occurring no later than 15 days from admission to the SOR Neurological Foundation don Gnocchi ONLUS IRCCS.

Exclusion Criteria

disorders of the visus and / or hearing, amputation of a limb (sup. Or inf.), cerebellar stroke; previous stroke (relapse), cognitive decline (MMSE<21).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment	1 day	Sensorimotor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28.; Higher scores represent better outcomes

Trial Locations

Locations (1)

Fondazione don Gnocchi; 🇮🇹 Firenze, Italy