NCT01092936Unknown不适用
Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
Fondazione Neureca1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2010年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Phase III: the primary outcome of phase III is to confirm factorial analysis of the Italian version against the factor structure of the English version, by each of the four sections of the scale.
研究概览
简要总结
The present study is part of an international program and deals with the translation and validation program for the Italian version of the MDS-UPDRS.
The program will be articulated in three steps:
- Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)
- Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of PD patients (approximately 10). Should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged.
- Phase III: large validation testing: this phase will involve 350 PD patients from 12-14 Italian PD centres.
The IRIS protocol deals with phase II and III of the program.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent;
- •native Italian-speaking patients or either sex;
- •patients suffering from Parkinson's disease ranging from mild to severe, based on clinical judgement;
- •presence of a native Italian-speaking caregiver.
排除标准
- •Patients with evidence of other central nervous system disorders;
- •patients with a degree of depression or dementia which may prevent and/or affect ratings.
结局指标
主要结局
Phase III: the primary outcome of phase III is to confirm factorial analysis of the Italian version against the factor structure of the English version, by each of the four sections of the scale.
时间窗: 6 months
Phase II: To test the appropriateness of the Italian translation and clear understanding of potentially cultural-sensitive items. To refine the translation, if necessary, prior to validation testing.
时间窗: 6 months
次要结局
- The secondary outcome is to determine the Differential Item Function (DIF) which will be run on items by gender, race , disease severity, education and age.(6 months)
研究者
研究点 (1)
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