Skip to content

Translation and Validation Fugl-Meyer in Italian Language

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03855618
Acronym
FMI
Enrollment
10
Registered
2019-02-27
Start date
2019-03-15
Completion date
2025-12-30
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation Fugl Meyer Scale in Italian

Keywords

Translation., Transcultural validation., Post-Stroke.

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.

Interventions

None listed

Sponsors

Göteborg University
CollaboratorOTHER
Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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). \-

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment1 daySensorimotor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28. Higher scores represent better outcomes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026