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临床试验/NCT02152319
NCT02152319已完成不适用

PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Great Lakes NeuroTechnologies Inc.2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年5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
21
试验地点
2
主要终点
Percent of subjects completing remote assessments

研究概览

简要总结

The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.

详细描述

Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
  • Be fluent in English
  • Willing and able to provide informed consent

排除标准

  • Inability to carry out study activities
  • Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
  • Subjects who have dementia, exhibited by those with a score less than 22 on the Montreal Cognitive Assessment (MoCA)
  • Subjects with deep brain stimulation (DBS)

结局指标

主要结局

Percent of subjects completing remote assessments

时间窗: 7 Months

Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.

次要结局

  • PACIC responses(7 Months)
  • Number and type of medication changes(7 Months)
  • Number of videoconferences completed(7 Months)
  • KHV Motor Scores(7 Months)
  • Percent of remote assessments completed(7 Months)
  • KHV measured fluctuations(7 Months)
  • Number of patient/clinician communications(7 Months)
  • Unified Parkinson's Disease Rating Scale (UPDRS)(7 Months)
  • PDQ-39 responses(7 Months)
  • PAM-13 responses(7 Months)
  • Number of clinic visits(7 Months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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