Translation and Validation Fugl-Meyer in Italian Language

Официальное название

Translation and Validation of the Evaluation Scale Fugl-Meyer in Italian Language

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Fugl-Meyer Assessment [Срок оценки: 1 day]

Критерии участия

Критерии включения

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.

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Критерии исключения

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

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 1 центр

• Fondazione don Gnocchi — Florence

Публикации

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. PMID 1135616
• Barbosa NE, Forero SM, Galeano CP, Hernandez ED, Landinez NS, Sunnerhagen KS, Alt Murphy M. Translation and cultural validation of clinical observational scales - the Fugl-Meyer assessment for post stroke sensorimotor function in Colombian Spanish. Disabil Rehabil. 2019 Sep;41(19):2317-2323. doi: 10.1080/09638288.2018.1464604. Epub 2018 Apr 24. PMID 29688080
• Lundquist CB, Maribo T. The Fugl-Meyer assessment of the upper extremity: reliability, responsiveness and validity of the Danish version. Disabil Rehabil. 2017 May;39(9):934-939. doi: 10.3109/09638288.2016.1163422. Epub 2016 Apr 10. PMID 27062881
• Santisteban L, Teremetz M, Bleton JP, Baron JC, Maier MA, Lindberg PG. Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review. PLoS One. 2016 May 6;11(5):e0154792. doi: 10.1371/journal.pone.0154792. eCollection 2016. PMID 27152853
• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2 PMID 15804318
• Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28. PMID 20874835
• Schuster C, Hahn S, Ettlin T. Objectively-assessed outcome measures: a translation and cross-cultural adaptation procedure applied to the Chedoke McMaster Arm and Hand Activity Inventory (CAHAI). BMC Med Res Methodol. 2010 Nov 29;10:106. doi: 10.1186/1471-2288-10-106. PMID 21114807
• Michaelsen SM, Rocha AS, Knabben RJ, Rodrigues LP, Fernandes CG. Translation, adaptation and inter-rater reliability of the administration manual for the Fugl-Meyer assessment. Rev Bras Fisioter. 2011 Jan-Feb;15(1):80-8. PMID 21519719

Идентификаторы

NCT: NCT03855618 · Fugl-Meyer Italian

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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