Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 800
- 试验地点
- 18
- 主要终点
- Proportion of questionnaires with errors after self completion
研究概览
简要总结
The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.
详细描述
Two questionnaires the WELCH and the "walking impairment questionnaire" (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •French Native language
- •18 years old or older
- •Signed consent
- •Covered by the French social care system
排除标准
- •Unable to participate for administrative reasons
- •Psychiatric troubles
- •Pain at rest or critical limb ischemia
- •Unable to walk (ex: wheelchair subjects)
- •Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.
结局指标
主要结局
Proportion of questionnaires with errors after self completion
时间窗: 1 day
Analysis of first inclusion only in patients that are included multiple times over the study period. Predetermined score for the WELCH questionnaire answers \[(4 items); (4 additions \& 1 multiplication)\] and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages
次要结局
- Correlation with treadmill result(1 day)
- Facility of the scoring of the questionnaires(1 day)
- Reliability of the questionnaire(3 weeks)
- sensitivity of the WELCH to changes(1 year)
- Correlation with ankle brachial index (ABI)(1 day)