Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Usability
研究概览
简要总结
Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
- •Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.
- •The Hoehn and Yahr (HY) stage during ON is 1-4/
- •MoCA ≥ 22/
- •Participant has signed the informed consent.
排除标准
- •Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
- •Significantly, impaired cognitive skills render the participant unable to use the TCD.
- •Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
- •Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).
结局指标
主要结局
Usability
时间窗: 2 weeks
Usability of the cueing device is measured by a self-developed questionnaire.
Acceptance
时间窗: 2 weeks
Acceptance is measured by a self-developed questionnaire.
Frequency using the device
时间窗: 2 weeks
How often the device is used (counts logging protocol).
System Usability Scale
时间窗: 2 weeks
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Setup cueing device
时间窗: 2 weeks
Time needed for the setup \[in seconds\] and the variations of the different setup parameters (cueing length \[seconds\], cueing strength \[% of maximum\], cueing cadence \[count/minutes\]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.
次要结局
- Cadence [steps/minute](1 week)
- Walking speed [meters/second](1 week)
- Step length right/left [in meters](1 week)
- Initial step latency [in seconds](1 week)
- Walking distance [in meters](1 week)
- Number of FOG(1 week)