跳至主要内容
临床试验/NCT05680961
NCT05680961进行中(未招募)不适用

Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices

Parkinson's & Movement Disorders Center of Maryland1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS

研究概览

简要总结

The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson's disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Subject is 18 years of age or older
  • Subject is able to provide informed written consent
  • Subject has been clinically diagnosed with Parkinson's Disease
  • Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described

排除标准

  • Inability to give informed consent
  • Presence of additional neurological disease aside from the diseases being studied
  • Inability to understand and follow the directions for the study

结局指标

主要结局

NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS

时间窗: Comparison will be performed upon completion of the study, approximately in 1 year.

We will compare symptom severity as predicted by NeuroRPM to UPDRS scores from clinical raters. Statistical significance will be evaluated by intraclass correlation and kappa-statistic.

次要结局

未报告次要终点

研究者

发起方
Parkinson's & Movement Disorders Center of Maryland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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