Kinesia 360 Multi-Center Parkinson's Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- % of assigned days with confirmed use
研究概览
简要总结
Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.
详细描述
This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Idiopathic Parkinson's Disease,
- •History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
- •Fluent in English
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 Montreal Cognitive Assessment (MoCa) score of 22 or less.
- •Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.
研究组 & 干预措施
Kinesia 360 Users
Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors.
干预措施: Kinesia 360 (Device)
结局指标
主要结局
% of assigned days with confirmed use
时间窗: 5 months
次要结局
- Diary measured Off time(5 months)
- On time with dyskinesia as measured by Kinesia 360(5 months)
- Off time as measured by Kinesia 360(5 months)
- PDQ-39 responses(5 months)
- Patient Activation Measure (PAM)-13 responses(5 months)
- Number of patient/investigator communications(5 months)
- Diary measured On time with dyskinesia(5 months)
- Patient Assessment for Chronic Conditions (PACIC) responses(5 months)
- Number of clinic visits(5 months)
- Unified Parkinson's disease rating scale (UPDRS)(5 months)
- Duration of time with patient(5 months)
- Number and type of medication changes(5 months)