跳至主要内容
临床试验/NCT04117997
NCT04117997招募中不适用

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 70 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
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 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.

详细描述

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.

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

  • 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.

排除标准

  • Visual and/ or hearing deficits, amputation of the upper or lower limb, cerebellar stroke; previous strokes (relapse), cognitive decline (MMSE<21).

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: 1 day

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

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

Dr. Francesca Cecchi

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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