Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- New Freezing of Gait Questionnaire (NFOGQ)
研究概览
简要总结
Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
- •Stable drug therapy without any change in the past one month
- •Subjective presence of FOG more than once per day
- •Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
- •Able to walk unaided at least 20 meters
- •Provide written informed consent
排除标准
- •Stroke and other diseases interfering ambulation
- •Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
- •History of deep brain stimulation surgery
结局指标
主要结局
New Freezing of Gait Questionnaire (NFOGQ)
时间窗: 2 weeks
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
Freezing severity
时间窗: 2 weeks
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
次要结局
- Quantitative Gait parameters(2 weeks)
- Number of falls and near falls(2 weeks)
- Berg Balance Scale(2 weeks)
- 39-item Parkinson's Disease Questionnaire (PDQ-39)(2 weeks)
- Clinical Global Impressions Scale (CGI-I)(2 weeks)
- MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III(2 weeks)