NCT07257393尚未招募不适用
Validation of a Mobile Health Application for Fall Risk Assessment in Parkinson's Disease: A Comparative Study Before and After Dopaminergic Medication Adjustment
Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in fall-risk index (Kinetikos Health App Sit-to-Stand)
研究概览
简要总结
This is a single-center, prospective observational study aiming to validate the Kinetikos Health App for fall risk assessment in PD patients undergoing dopaminergic medication adjustments.
详细描述
Falls are common and disabling in PD. Dopaminergic medication effects on fall risk remain inconclusive. This study validates the Kinetikos Health App for objective fall risk assessment before and after medication adjustment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD diagnosis (MDS criteria);
- •On levodopa monotherapy with motor fluctuations;
- •Planned to start opicapone or safinamide;
- •Consent provided.
排除标准
- •Atypical/secondary parkinsonism;
- •Moderate-severe dementia;
- •DBS/MRgFUS/neurosurgery within 6 months;
- •Severe comorbidities limiting test
结局指标
主要结局
Change in fall-risk index (Kinetikos Health App Sit-to-Stand)
时间窗: From baseline to 3 months
次要结局
- UPDRS(From baseline to 3 months)
- LEDD(From baseline to 3 months)
- Fall events(From baseline to 3 months)
研究者
研究点 (1)
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