Validation Fugl-Meyer in Italian Language (FMI)

Validation Fugl-Meyer Scale in Italian Clinical Trial

Official title:

Validation of the Evaluation Scale Fugl-Meyer in Italian Language

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04117997
• Other study ID #: Fugl-Meyer Italian 2
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: October 2021

Study information

• Verified date: November 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Francesca Cecchi, MD
• Phone: 05573931
• Email: fcecchi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria: 60 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).

Related Conditions & MeSH terms

• Validation Fugl-Meyer Scale in Italian

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Göteborg University

References & Publications (13)

Barbosa NE, Forero SM, Galeano CP, Hernández 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. Disabi — View Citation

Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull. 1968 Oct;70(4):213-20. — View Citation

Fugl-Meyer AR, Jääskö 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. — View Citation

Kazdin AE. Artifact, bias, and complexity of assessment: the ABCs of reliability. J Appl Behav Anal. 1977 Spring;10(1):141-50. — View Citation

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. — View Citation

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. — View Citation

Sánchez R, Echeverry J. [Validating scales used for measuring factors in medicine]. Rev Salud Publica (Bogota). 2004 Sep-Dec;6(3):302-18. Spanish. — View Citation

Santisteban L, Térémetz 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 2 — View Citation

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 — View Citation

See J, Dodakian L, Chou C, Chan V, McKenzie A, Reinkensmeyer DJ, Cramer SC. A standardized approach to the Fugl-Meyer assessment and its implications for clinical trials. Neurorehabil Neural Repair. 2013 Oct;27(8):732-41. doi: 10.1177/1545968313491000. Ep — View Citation

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 — View Citation

Svensson E. Different ranking approaches defining association and agreement measures of paired ordinal data. Stat Med. 2012 Nov 20;31(26):3104-17. doi: 10.1002/sim.5382. Epub 2012 Jun 19. — View Citation

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) Mea — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day