Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Assess the prevalence of spasticity in subjects with RRMS
研究概览
简要总结
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
详细描述
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged from 21 60 years of age
- •Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- •Subjects with a diagnosis of RRMS for more than one year
- •The subject who have signed the Informed Consent
排除标准
- •Subjects with other causes of spasticity
- •Subjects with other clinical forms of MS (different from relapsing-remitting)
结局指标
主要结局
Assess the prevalence of spasticity in subjects with RRMS
时间窗: Initial visit (Day 0) to 24 months
Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
次要结局
- Evaluation of the impact of spasticity on the quality of life of subjects with RRMS(Initial visit (Day 0) to 24 months)
- Evaluation of the changes in spasticity after 24 months(Initial visit (Day 0) to 24 months)