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To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients

2013年10月13日更新者：Merck KGaA, Darmstadt, Germany

Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina

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.

研究概览

地位

完全的

条件

多发性硬化症，复发缓解

详细说明

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.

研究类型

观察性的

注册 (实际的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

阿根廷
- - Rosario、阿根廷
    - Fundacion Rosarina de Neurorehabilitacion

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects with established diagnosis of RRSM for more than one year.

描述

Inclusion Criteria:

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

Exclusion Criteria:

Subjects with other causes of spasticity
Subjects with other clinical forms of MS (different from relapsing-remitting)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Assess the prevalence of spasticity in subjects with RRMS 大体时间：Initial visit (Day 0) to 24 months	Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36	Initial visit (Day 0) to 24 months

次要结果测量

结果测量	大体时间
Evaluation of the impact of spasticity on the quality of life of subjects with RRMS 大体时间：Initial visit (Day 0) to 24 months	Initial visit (Day 0) to 24 months
Evaluation of the changes in spasticity after 24 months 大体时间：Initial visit (Day 0) to 24 months	Initial visit (Day 0) to 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck KGaA, Darmstadt, Germany

调查人员

首席研究员：Dr. Jose A. Brizuela、Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年8月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2010年3月2日

首先提交符合 QC 标准的