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临床试验/NCT05780866
NCT05780866已完成不适用

Remote Monitoring in Parkinson's Disease

Jacob E. Simmering2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Activity tracker wear rate

研究概览

简要总结

The goal of this observational study is to learn about the usefulness of physical activity measures and tremor detection using wearable devices and smartphone video to detect and evaluate disease burden in people with Parkinson's disease.

Participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task. They will wear the activity tracker for two weeks at home.

详细描述

For all groups (there is no control group):

At enrollment, the participants will complete a baseline survey that records participant sex, years since the diagnosis of Parkinson's disease, current use of levodopa medication, and whether levodopa was taken today.

Next, a research nurse from neurology will complete the Unified Parkinson's Disease Rating Scale (UPDRS) assessment. As part of this assessment, the researchers will make a video recording of Part 3 (the motor assessment) as a gold standard for comparison with the participant-recorded videos.

Next, the participant will complete the PDQ-39 (Parkinson's disease questionnaire), a 39 item questionnaire about the quality of life.

After completing the PDQ-39, the researchers will provide the participant with a camera, small tripod, and a set of written directions about how to perform the UPDRS motor assessment. The goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team. The recordings will then be converted to x, y, z landmarks using MediaPipe, running on UIowa hardware.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Activity tracker wear rate

时间窗: 14 Days

Percent of time activity tracker records a heart rate

Accuracy of computer vision assessment of motor function

时间窗: Baseline

Average difference in UPDRS score between human and computer assessments

Do step counts predict quality-of-life

时间窗: 14 Days

Regression of PDQ-39 on demographics and activity tracker step counts

次要结局

未报告次要终点

研究者

发起方
Jacob E. Simmering
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacob E. Simmering

Assistant Professor

University of Iowa

研究点 (2)

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