跳至主要内容
临床试验/NCT03855618
NCT03855618Enrolling By Invitation不适用

Translation and Validation of the Evaluation Scale Fugl-Meyer in Italian Language

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
10
试验地点
1
主要终点
Fugl-Meyer Assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • disorders of the visus and / or hearing, amputation of a limb (sup. Or inf.), cerebellar stroke; previous stroke (relapse), cognitive decline (MMSE<21).

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Cecchi

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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