Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Validate the French version of the AMSQ self-questionnaire in a population of MS patients
研究概览
简要总结
Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.
详细描述
A specific self-questionnaire for patients with MS has recently been developed and validated in English and Dutch: "The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)". The questionnaire groups 31 items and was created from questionnaires developed for other pathologies. The Dutch team that developed this questionnaire combines biostatisticians and neurologists, experts in the development and validation of disability measurement tools.
This study aims to validate the French version of AMSQ questionnaire. This study is carried out in collaboration with the Amsterdam team, which has carried out the methodology and will conduct the statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient with MS according to the diagnostic criteria of 2010
- •Age ≥18 years
- •Patients seen in consultation at the SEP reference center in Rennes
排除标准
- •Other neurological or rheumatological pathology hindering the use of the upper limbs
- •Inability to understand
- •Major persons subject to legal protection (legal safeguards, guardianship)
- •Persons deprived of their liberty
结局指标
主要结局
Validate the French version of the AMSQ self-questionnaire in a population of MS patients
时间窗: At inclusion
Evaluate item fit of the French version of the AMSQ using the graded response model, developed by Samejima (cf. reference)
次要结局
未报告次要终点