Validation Fugl Meyer Scale in Italian Clinical Trial
Official title:
Translation and Validation of the Evaluation Scale Fugl-Meyer in Italian Language
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.
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.
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