Kinesia HomeView - Home Diary Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Test-retest reliability
研究概览
简要总结
The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Clinical diagnosis of Parkinson's disease
- •On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks
- •Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32)
- •With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33)
- •Capable of accurately completing diaries
- •Capable of accurately using Kinesia HomeView
排除标准
- •Significant medical or psychiatric illness
- •Subjects not capable of following the required clinical instructions
- •Serious medical conditions that would compromise safety
研究组 & 干预措施
Hand-written diary first
Participants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks.
干预措施: Kinesia HomeView (Device)
Hand-written diary first
Participants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks.
干预措施: Hand-written diary (Other)
Kinesia HomeView first
Participants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks.
干预措施: Kinesia HomeView (Device)
Kinesia HomeView first
Participants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks.
干预措施: Hand-written diary (Other)
结局指标
主要结局
Test-retest reliability
时间窗: 4 weeks
Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.
次要结局
- Kinesia HomeView usability questionnaire(After 4 weeks)