Validation of the Fugl-Meyer Assessment Scale in Italian
Validation of the Evaluation Scale Fugl-Meyer in Italian Language
This study is testing a new Italian version of a tool that helps doctors check how well stroke patients can move their arms and legs to make sure it works well in Italy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT04117997 on ClinicalTrials.gov |
What this trial studies
This study aims to culturally validate the Italian translation of the Fugl-Meyer Assessment (FMA) scale for upper and lower limb evaluation in post-stroke patients. The FMA is a widely recognized tool for assessing sensorimotor function in stroke patients, originally developed in English and Swedish. The research involves a methodological approach to ensure accurate translation and cultural adaptation, with the involvement of the University of Gothenburg. The translated scale will be tested by physiotherapists at the Don Carlo Foundation to identify any linguistic and conceptual discrepancies.
Who should consider this trial
Good fit: Ideal candidates for this study are in-patients who have experienced their first-ever stroke within the last 15 days.
Not a fit: Patients with visual or hearing deficits, cognitive decline, or those who have had previous strokes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated assessment tool for Italian-speaking clinicians to evaluate stroke patients more effectively.
How similar studies have performed: Other studies have successfully validated the Fugl-Meyer Assessment in various languages, indicating a strong precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Florence
- IRCCS Fondazione Don Carlo Gnocchi, Firenze — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Cecchi, MD
- Email: fcecchi@dongnocchi.it
- Phone: 05573931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.