Clinical trial NCT04117997: Validation Fugl-Meyer in Italian Language (FMI)
Official title: Validation of the Evaluation Scale Fugl-Meyer in Italian Language
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Validation Fugl-Meyer Scale in Italian
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2019-10-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 individuals with stroke consecutively admitted to the neurological department at The Don Carlo Foundation, 4-9 days post-stroke. The patients will be aged between 18-90 years old.

Brief summary: The aim of the study is to perform a cultural validation of the Italian translation of the Fugl-Meyer Assessment scale for the upper and the lower limb on a group of post-stroke patients admitted to the neurological department at The Don Carlo Foundation.

The purpose is to validate the Italian translation of the Fugl-Meyer Assessment scale in order to allow immediate clinical use.

Detailed description: The Fugl-Meyer Assessment (FMA) is one of the most used and recommended assessment scales of sensorimotor function in stroke. It was introduced for the first time by Axl Fugl-Meyer and collaborators and originally published in both English and Swedish, representing the first quantitative assessment tool for the hemiplegic patient.

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

There are many currently translation and cultural validation studies of the FMA in several languages (Danish, Norwegian, Spanish, French), but an official version validated in Italian is no available to date.

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

The translated version in Italian is tested by 3 physiotherapists admitted to the neurological department at The Don Carlo Foundation, in order to identify lingual and conceptual inconsistencies that could influence the score, the understanding, the interpretation and the cultural equivalence of the scale.

Eligibility criteria: Inclusion Criteria: 70 individuals with first-ever stroke will be enrolled. Eligible subjects will be in-patients with an acute event occurred no later than 15 days from admission at the "neurological department " at the Don Carlo Gnocchi Foundation.

Exclusion Criteria:

Visual and/ or hearing deficits, amputation of the upper or lower limb, cerebellar stroke; previous strokes (relapse), cognitive decline (MMSE\<21).

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi, Firenze
Study officials:
References:
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