An observational study in Validation Fugl-Meyer Scale in Italian, sponsored by Fondazione Don Carlo Gnocchi Onlus. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational
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.
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.
Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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 (\<21).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fugl-Meyer Assessment
sensory and motor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28. Higher scores represent better outcomes
Time frame: 1 day
Plan to share: No — We haven't plan to share data.
Started Nov 2022 (actual). Primary completion is estimated for May 2025, 30 months after the start.
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