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临床试验/NCT00710645
NCT00710645已完成不适用

Assessment of Spasticity in MS Patients Using a Lido Workset

University of California, Davis1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2003年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Assess measure of spasticity

研究概览

简要总结

This is a single-site, pilot study. In this study, we hope to learn if the Lido Workset is a sensitive measure of limb spasticity in patients with Multiple Sclerosis (MS). The Lido Workset is a FDA approved, non-invasive device which has been used to assess motor function and spasticity. The testing will take approximately 25 minutes. Subjects will lie down on a table and have a leg attached to the Lido Workset device arm. The Lido Workset will move the leg back and forth many times at different speeds. The Lido Workset will also analyze resistance to passive (while subject is not moving or resisting movement) movement of the wrist and knee.

详细描述

The information gathered from testing individuals with spasticity due to multiple sclerosis with the Lido Workset has been important in making adjustments to the Lido Workset to show a greater degree of sensitivity in assessing varying degrees of spasticity.

Healthy control subjects will be used to compare the spasticity data of multiple sclerosis subjects with subjects with normal muscle tone to determine the sensitivity of the Lido measurements.

The testing will be performed one time for each patient and will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected subjects from both the MS subjects and control subjects. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks. This additional testing will be done in order to compare the results with the Lido data obtained at similar timepoints from the subjects enrolled in the Cannabis for Spasticity in MS study. Each subject will be given the option to participate in the extended testing or to decline.

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

入选标准

  • Must have a diagnosis of multiple sclerosis and
  • Must have some degree of spasticity or
  • Must be a healthy control subject
  • Ability to give informed consent

排除标准

  • Patients with any life-threatening or unstable clinically significant disease
  • Patients with other causes of reduced range of motion of the knee or wrist

结局指标

主要结局

Assess measure of spasticity

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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