The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in self-selected walking speed (m/s)
研究概览
简要总结
The study tests whether a smart shoe (NUSHU) that provides vibrotactile stimulation can improve walking speed in people with Parkinson's disease. Sixteen participants complete two short walking tests-with and without vibration-to compare gait speed, cadence, stride length, usability, and safety. It is a low-risk pilot study meant to generate first evidence for future research.
详细描述
Study Overview
This monozentric, prospective within-subject crossover pilot study investigates whether vibrotactile stimulation provided by the NUSHU, a CE-certified smart shoe, can influence spatiotemporal gait parameters-primarily self-selected walking speed-in adults with Parkinson's disease (PD). Parkinson's disease is often associated with reduced gait speed, shorter strides, and altered cadence, all of which are clinically relevant because they correlate with morbidity, fall risk, and quality of life.
Rationale
Earlier research suggests that vibration can positively influence gait by modulating proprioception, but existing devices have been impractical or clinically cumbersome. The NUSHU integrates sensors and vibration modules into an everyday shoe, enabling precise, phase-specific stimulation during the swing phase. Since no previous PD studies have tested this device, the project seeks to assess feasibility, safety, and initial efficacy signals.
Participants
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
- •A medically confirmed diagnosis of Parkinson's disease on the physiotherapy prescription.
- •Stable medication for at least four weeks (no change in dopaminergic therapy).
- •The ability to walk at least 200 metres without stopping.
- •Minimum age: 18 years
- •Sufficient knowledge of German to understand the study information and complete the questionnaires.
- •Written informed consent form
排除标准
- •Atypical or secondary Parkinsonism
- •Sensory disturbances in the feet (e.g. polyneuropathy).
- •Other neurological, orthopaedic or internal medical conditions that significantly affect walking
- •Cognitive impairments that interfere with understanding the study information or following instructions
研究组 & 干预措施
Vibrotactile feedback while walking
干预措施: Vibrotactile feedback during walking (Device)
结局指标
主要结局
Change in self-selected walking speed (m/s)
时间窗: Once during 120 seconds
Change in self-selected walking speed (m/s), measured over a 2-minute walking test with and without stimulation by the NUSHU. Walking speed is measured in m/s as a continuous metric variable, which is an objective and established way of measuring walking speed. The calculation is performed by dividing the total distance covered by the time in seconds (120 seconds).
Change in self-selected gait speed
时间窗: One visit of 45 minutes
次要结局
未报告次要终点