SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Freezing of Gait (FoG) Episodes
研究概览
简要总结
People with Parkinson's disease (PD) may experience a walking problem called freezing of gait (FoG) that can interfere with the person's ability to conduct daily activities. FoG has been described as feeling like one's feet are glued or stuck to the floor. Drug treatments for PD rarely improve FoG. Researchers have found that vibration therapy may help improve FoG. The purpose of this research study is to test the safety, tolerability, and effectiveness of using a wearable device (UG motion sensor, that is the size of a watch) that will recognize FoG and then send a signal to another small watch-like device (PDVibe3) to deliver a vibration stimuli to participant's feet. The researchers believe the vibration stimulus (which feels like a phone on vibration mode) will help reduce FoG in persons with PD. The study is open to people who have been diagnosed with Parkinson's disease, have FoG, and meet the study entry requirements.
The PDVibe3 is an investigational device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The UG motion sensor is also an investigational device.
详细描述
Usual care for PD involves taking medications to help with disease. In this study, participants will receive usual care. Participants will be asked to have taken their medication before they arrive, and to bring extra medicine with them should their next dose be due while they are at the study site.
Participants will be asked to walk on certain paths, and when the device detects a freeze in their gait, they will receive a dose of vibration to their feet. This vibration is felt differently by different people and it may feel very light or a little stronger (like a phone set to vibrate), or it may feel somewhere in between.
During the study, participants will be asked to do the following things:
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Visit the research site at VCU, one time for the study
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Complete a short cognitive exam
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Answer questions about their medical history
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Complete a few brief surveys about fatigue, balance, falls, freezing of gait, quality of life, and activities of daily living
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Complete a 10-meter walk test
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Wear the UG motion sensor (which detects FoG) on each ankle
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Wear the PDVibe3 (which provides vibration) on each ankle
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Walk five, 5-meter scenarios without vibration, and then again three more times with vibration therapy in a public setting on VCU campus. The five scenarios include:
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Walking through a narrow passage
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Walk and turn 540 degrees
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Walk toward a chair
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Walk while performing a verbal task
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Walk through a door before it closes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years,
- •Parkinson's disease (PD) diagnosed by a movement disorder specialist using UK Brain Bank criteria,
- •are able to walk independently or with a simple device (e.g., cane or walker), and
- •are observed by the research team to have PD-related FoG in at least two of the five previously described common trigger scenarios (i.e., freezing upon gait initiation, walking through tight quarters, freezing when changing directions, approaching a visual target, dual tasking, and stressful, time sensitive situations such as entering an elevator before the doors close).
- •individuals with known Parkinson plus syndrome,
- •presence of dementia (Montreal Cognitive Assessment < 21),
- •an additional disorder (not related to PD) impairing gait,
- •history of implantable cardiac device or any other implanted electronic device except DBS,
- •peripheral neuropathy (determined by use of tuning fork to check for ability to feel vibration),
- •any condition that, in the opinion of the PI, would compromise participant safety, data integrity, or data interpretation,
- •pregnancy.
排除标准
- 未提供
研究组 & 干预措施
Vibration therapy
5-meter walk scenarios with vibration therapy
干预措施: UG motion sensor with PDVibe3 (Device)
结局指标
主要结局
Number of Freezing of Gait (FoG) Episodes
时间窗: Baseline to final walk task - up to 5 hours
Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.
Duration of Freezing of Gait (FoG) Episodes.
时间窗: Baseline to final walk task - up to 5 hours
Participants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration.
次要结局
未报告次要终点