Validation of the French Version of the PLSFRS Scale
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- French version of the PLSFRS scale
研究概览
简要总结
This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale
详细描述
This is a prospective study conducted in 8 French ALS centers which will enroll 80 patients with PLS. All these patients will undergo an evaluation of their functional status from the ALSFRS-r and PLSFRS scales. All patients will be evaluated at 3 time points (T0,M6 at the outpatient clinic) and at M3 remotely. The aim of the study will be to validate a trans-cultural and psychometric version of the PLSFRS available for the French PLS population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary lateral sclerosis (PLS)
- •Age over 18 years
- •Informed consent signed
- •Patients cared in a French ALS centre
排除标准
- •patients with no oral and written command of the French language
- •Patients unable to answer a questionnaire
- •Opposition to data processing
研究组 & 干预措施
Patients with a primary lateral sclerosis
干预措施: Assessment of the functional status (Other)
结局指标
主要结局
French version of the PLSFRS scale
时间窗: inclusion and 6 months
10 items with a score from 0 to 6; 2 items with a score from 0 to 4 Maximal score is 68.
次要结局
- Change Global Impression (CGI) scale(6 months)