PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
试验速览
- 阶段
- 不适用
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Long-Range Autocorrelation (LRA)
研究概览
简要总结
The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.
详细描述
None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment.
The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be "smoothed" by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease.
Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease diagnosis positive according to UK Brain Bank criteria
- •Hoehn and Yahr score of 1 to 3
- •Mini-mental state (MMSE) higher than 24
- •Optimal drug treatment for at least 4 weeks at the time of inclusion
- •No contraindication to physical exercising (ACSM criteria)
排除标准
- •Not being able to understand French well enough
- •Not being in the targeted age range
结局指标
主要结局
Long-Range Autocorrelation (LRA)
时间窗: From day 0 up to 8 weeks
Assesses the variability between stride durations
次要结局
- Unified Parkinson's disease rating scales (UPDRS)(From day 0 up to 8 weeks)
- Activities-Specific Balance Confidence Scale (ABC)(From day 0 up to 8 weeks)
- Joint torques(From day 0 up to 8 weeks)
- Gait analysis(From day 0 up to 8 weeks)
- System Usability Scale (SUS)(After 4 weeks)
- Physiological Cost Index(From day 0 up to 8 weeks)
- Balance Evaluation Systems Test (BESTest)(From day 0 up to 8 weeks)