Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Translation and Validation Fugl-Meyer in Italian Language (FMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855618
Recruitment Status : Unknown
Verified November 2019 by Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus.
Recruitment status was:  Active, not recruiting
First Posted : February 27, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Validation Fugl Meyer Scale in Italian

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Translation and Validation of the Evaluation Scale Fugl-Meyer in Italian Language
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : July 15, 2019
Estimated Study Completion Date : December 30, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1 case group
Consecutive 10 post-stroke patients in intensive rehabilitation treatment with an acute event occurring no later than 15 days from admission to the SOR Neurological Foundation don Gnocchi ONLUS IRCCS; age 18-90. It is required to sign an informed consent to the patient's participation in the study or if unable to sign, of the proxy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fugl-Meyer Assessment [ Time Frame: 1 day ]

    Sensorimotor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28.

    Higher scores represent better outcomes



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Post-stroke patients in intensive rehabilitation treatment.
Criteria

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).

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855618


Locations
Layout table for location information
Italy
Fondazione don Gnocchi
Firenze, Italy, 50143
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Göteborg University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Francesca Cecchi, Principal Investigator, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT03855618    
Other Study ID Numbers: Fugl-Meyer Italian
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus:
Translation.
Transcultural validation.
Post-Stroke.