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临床试验/NCT04285957
NCT04285957已完成不适用

Italian Translation and Transcultural Validation of Two Assessment Tools for Participation in Stroke Survivors: the Frenchay Activity Index and the Walking Handicap Classification (FAIWHC)

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: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Internal consistency (FAI)

研究概览

简要总结

This study is aimed at providing an Italian version of two assessment tools for participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC) by a standardized translation and transcultural validation protocol. The protocol includes a pre-test of the Italian version on ten patients, a final revision, and a validation on a sample of 60 stroke patients.

详细描述

This study is aimed at providing an Italian version of two tools to assess participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC). These tools have been recently indicated for the assessment of participation in Stroke patients by the Italian Association of Physical and Rehabilitation Medicine (Minimal Stroke Assessment Protocol - PMIC2); they are currently used in Italian research and clinical settings, but no official translation exists. The process requires a standardized translation protocol, including forward and backward translation, using a multistep revision structure, to ensure conceptual and semantic equivalence. The validation process includes a pilot evaluation of on 10 individuals post-stroke admitted to the Neurological Rehabilitation Unit, Foundation Don Gnocchi Scientific Institute, and a validation on a sample of 60 stroke patients including reliability, internal consistency and concurrent validity assessment of the translated version against the Sickness Impact Profile (SIP) - Italian version and the Rivermead Mobility Index (RMI) - Italian version, respectively

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Internal consistency (FAI)

时间窗: 1 year

Cronbach's alpha\>=0,70

Interrater reliability

时间窗: 1 year

Intraclass Correlation Coefficient \>=0,70

concurrent validity of FAI against SIP

时间窗: 1 year

Spearman's coefficient \>=0.25-0.50

concurrent validity of WHC against RMI

时间窗: 1 year

Spearman's coefficient \>=0.25-0.50

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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