跳至主要内容
临床试验/NCT03660098
NCT03660098已完成不适用

Mirror Box Therapy As a Treatment Option for Functional Movement Disorders

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise

研究概览

简要总结

The purpose of this study is to investigate the potential of using mirror box therapy as a therapeutic technique amongst patients with functional movement disorders. It is hypothesized that a brief, single, in-office mirror therapy session will lead to a noticeable decrease in FMD-related involuntary movements.

详细描述

Patients diagnosed with Functional Movement Disorder presenting with a unilateral or asymmetrical bilateral hand tremor will be asked to participate in a series of hand exercises with and without a mirror box. The severity of the tremor will be rated subjectively by the subject and objectively by the neurologist after hand exercises with and without the mirror box.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients diagnosed with functional movement disorder by a fellowship trained movement disorders neurologist, presenting predominantly with unilateral or asymmetrical bilateral involuntary movement in the upper extremity
  • In patients with bilateral involuntary movements, the symptoms in one arm must be minimal

排除标准

  • Patients with moderate to severe involuntary movement in both arms
  • Significant cognitive impairment that prevents proper informed consent
  • Severe involuntary movement that interferes with the use of the apparatus
  • Patients with hemiparesis or the loss of one arm due to various reasons (e.g. amputations, birth defects, etc.

结局指标

主要结局

Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise

时间窗: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year

The difference in scored movement severity in the more affected hand based on the modified s-FMDRS scale during the Unified Parkinson's Disease Rating Scale (UPDRS) exam after the exercises with vs. without the mirror box. Movements are scored by video raters on a scale of 0-3, and higher score indicates more severe movement.

次要结局

  • Change in self-perception(Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year)
  • Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise(Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Xin Yu, MD

Attending Physician

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验