Tremor Retrainer Software Application for Functional Tremor
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- mHealth Application Usability Questionnaire
研究概览
简要总结
The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:
- Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?
- Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?
详细描述
Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol.
The study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1.
For Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups.
For Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration.
For Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 years and older, any gender, any race
- •Functional tremor as defined by Espay and Lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment.
- •Access to internet and a laptop or tablet with a videocamera.
- •Informed consent obtained and signed
- •Subject understands study procedures and is able to comply with study procedures for duration of study
排除标准
- •Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor
- •Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia
- •Hearing impairment not addressed by hearing aids
- •Prior enrollment in clinical trial involving the Tremor Retrainer application
研究组 & 干预措施
Intervention Arm
All subjects will receive intervention with Tremor Retrainer smartphone application
干预措施: Tremor Retrainer Smartphone Application (Device)
结局指标
主要结局
mHealth Application Usability Questionnaire
时间窗: Study visit 3
Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability
Simplified Functional Movement Disorder Rating Scale
时间窗: Study visits 1-4
Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)
次要结局
未报告次要终点
研究者
Jordan F Garris
Principal Investigator
University of Virginia