Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Score of Comfort Level of Device in Satisfaction Survey
研究概览
简要总结
Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Parkinson's Disease:
- •Inclusion Criteria:
- •Male or female ≥ 18 years of age.
- •A diagnosis of Parkinson's disease
- •Able to give written informed consent (as determined by the investigator)
- •Can converse in English and read and perform all study activities
- •Has willingness and ability to comply with study requirements
排除标准
- •Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
- •A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
- •Persons with disorders other than PD significantly affecting gait as determined by the investigator
- •History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
- •Inability to wear interventional device
- •Unable to ambulate independently at least with assistive walking device but without additional person assistance
- •Pregnant or planning pregnancy within study timeframe
- •Montreal Cognitive Assessment (MoCA) score < 22 at screening
- •Resides in a nursing home or assisted care facility
- •Healthy Controls:
- •Inclusion Criteria:
- •Male or female ≥ 18 years of age.
- •No neurological disease or other significant gait impairment as deemed by the study investigator
研究组 & 干预措施
Parkinson's Disease (Early)
The early PD group will be those within 3 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
干预措施: NUSHU shoe (Device)
Parkinson's Disease (Moderate)
The moderate PD group will be those with 4-7 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
干预措施: NUSHU shoe (Device)
Parkinson's Disease (Advanced)
The advanced PD group will be those with at least 8 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
干预措施: NUSHU shoe (Device)
Healthy Controls
Healthy controls will include those without any neurological disease or other significant gait impairment. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.
干预措施: NUSHU shoe (Device)
结局指标
主要结局
Mean Score of Comfort Level of Device in Satisfaction Survey
时间窗: At Safety Follow Up (Week 18)
The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How would you rate the comfort level of the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning most uncomfortable and 5 meaning most comfortable. Mean score for each individual question will be provided.
Mean Score of Ease of Using Device in Satisfaction Survey
时间窗: At Safety Follow Up (Week 18)
The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How easy was it to use the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning very easy and 5 meaning very difficult. Mean score for each individual question will be provided.
Ratio of Participants Who Completed Study to Total Number of Participants Enrolled
时间窗: Through study completion, 18 weeks
We would like to measure the retention rate to assess feasibility. The lowest ratio would be 0, and the highest ratio would be 1.
次要结局
- Mean Change from Baseline to Week 12 in TUG test(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in FOG Questionnaire(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in MDS-UPDRS III(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Stride Time(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Stride Length(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Swing Time(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Stance Time(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Velocity(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Cadence(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Swing Phase(At Baseline and In 12 Weeks)
- Mean Change from Baseline to Week 12 in Stance Phase(At Baseline and In 12 Weeks)