NCT05349019终止不适用
A Natural History Study of Patients With Parkinson's Disease (PD) Caused by the p.Gly2019Ser (G2019S) Pathogenic Mutation of the Leucine-Rich Repeat Kinase 2 (LRRK2) Gene
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Compare the change over 12 months in the modified Timed Up and Go (mTUG) test
研究概览
简要总结
To characterize using a participant centered decentralized (at home) study featuring wearable technology and telemedicine to study disease change over time in patients with PD caused by the G2019S mutation in the LRRK2 gene and to identify a clinical endpoint(s) for disease modifying experimental therapy trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Compare the change over 12 months in the modified Timed Up and Go (mTUG) test
时间窗: 12 months
To compare the change over 12 months in the modified Timed Up and Go (mTUG) test, or subitems of the mTUG, recorded by video and a smartphone sensor application between participants with PD caused by the G2019S pathogenic mutation of the LRRK2 gene, and age and sex matched healthy control cohort
次要结局
- Evaluate the change over 12 months in cadence parameter in ambulation and gait.(12 months)
- Evaluate the change over 12 months in linear velocity parameter in ambulation and gait.(12 months)
- Evaluate the change over 12 months in stride length parameter in ambulation and gait.(12 months)
- Evaluate the change over 12 months in double support parameter in ambulation and gait.(12 months)
研究者
研究点 (1)
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