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临床试验/NCT04142528
NCT04142528Unknown不适用

ParkinPal: Patient-Centered PD Ambulatory Monitoring System

Great Lakes NeuroTechnologies Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Useability

研究概览

简要总结

This a usability study of a wearable sensor platform that utilizes a smartwatch to periodically record motion data. That data is processed in a connected smartphone and translated into symptom scores for dyskinesia, slowness, and tremor. The research subjects will use the wearable system over the course of five weeks, during which a change in therapy regimen is prescribed by the physician. Research analysis will be focused on patient and clinician experiences with the app and its reports.

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

  • Existing Patient of Collaborating Physician (David E. Riley, MD)
  • Diagnosed With Parkinson's Disease
  • Hoehn & Yahr Scale I-III
  • Ambulatory and capable of using the ParkinPal system
  • Able to understand and follow instructions regarding using the device

排除标准

  • Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.

结局指标

主要结局

Useability

时间窗: 6 weeks

Following the study, patients will complete questionnaires on their experience with the wearable system.

次要结局

  • Symptom scores(6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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