Exploration of the Short-term Effects and User Satisfaction of the Ceriter Stride One (CSO) Regarding the Prevention and Treatment of Freezing or Gait in Persons With Parkinson's Disease (pwP).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The difference between the pressure of steps with left versus right foot; as a measure of gait asymmetry.
研究概览
简要总结
The Ceriter Stride One (CSO) is a "smart sole" with pressure sensors. The sole allows data on the displacement of the body's centre of gravity (COG), as well as spatiotemporal parameters, to be obtained via pressure recordings. Logarithms, released on the data captured by the sole, make it possible to recognise propulsion (forward movement of the CG), accompanied by a reduction in step length (festination) or feet remaining standing (freezing of gait). When the system registers incipient propulsion, an audio signal ("stop") is generated via an audio device and app on the mobile phone. The CSO aims to make the pwP stop before balance disturbance can occur, preventing further propulsion and falls.
The aim of the study is to explore the short-term effects of the CSO in terms of reducing (preventing) freezing of gait and fall risk in a pilot group of pwP whose functionality is limited (Hoehn and Yahr 4). Short-term impact on gait (episodes of freezing of gait, mean step length, mean gait speed) will be evaluated and user satisfaction surveyed.
详细描述
There is scientific evidence for making pwP stop at the onset of propulsion (when step length decreases and step frequency increases) in order to get the COG back within the base of support. Similarly, (auditory) cues are recommended to facilitate starting.
These principles are implemented with the CSO : the device makes the pmP stop at onset of propulsion and generates an auditory, rhythmic cue to facilitate starting and walking with larger steps (prevention).
This is an innovative application, not a standard-of-care intervention.
Protocol :
20 persons with Parkinson's disease (H&Y 4) (attending physical therapy at Movita).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- 否
入选标准
- •Parkinson's disease (or other Parkinsonism)
- •gait impairment with freezing of gait (FOG)
- •18-80 years old
- •I.C. (informed consent)
- •Montreal Cognitive Assessment (MoCA) >25
排除标准
- •unable to walk 4m without assistance
- •MoCA < 25
结局指标
主要结局
The difference between the pressure of steps with left versus right foot; as a measure of gait asymmetry.
时间窗: 2 times 3 minutes
mean presure data of left foot versus mean pressure data of right foot
The number of captured episodes with freezing of gait (FOG)
时间窗: 2 times 3 minutes
n (number of captured FOG-episodes : the less, the better)
mean step length
时间窗: 2 times 3 minutes
mean step length (cm)
The number of captured steps
时间窗: 2 times 3 minutes
n (number - more steps relate to a better mobility)
次要结局
- users satisfaction(after testing (5 min))