Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Correlation with disability
研究概览
简要总结
Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking.
详细描述
Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking ability in MS patients individuals (eg MS patients). This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing information from IGP on gait alteration in MS.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 64 years
- •Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
- •No relapse within the last 5 weeks before recruitment
- •Able to walk with or without assistance/help/aid (one or 2 canes)
- •EDSS [0-6]
排除标准
- •Women who are pregnant
- •Patient having expressed their opposition
- •Patient under guardianship or security measure
结局指标
主要结局
Correlation with disability
时间窗: One time point per patient (inclusion)
Correlation of gait measures (mean amplitude of walking cycles (m), mean duration of walking cycles (s), Stance swing phase ratio) obtained during a walk of 25 feet with Expanded Disability Status Scale (EDSS). EDSS is an ordinal scale measuring disability and ranging from 0 (normal examination) to 10 (death due to MS) in a 0,5-point increments from score 1.
次要结局
- Correlation with neurological function(One time point per patient (inclusion))
- Correlation with gait speed(One time point per patient (inclusion))
- Correlation with lateralization(One time point per patient (inclusion))
- Correlation with disability location(One time point per patient (inclusion))
- Correlation with MS symptoms severity(One time point per patient (inclusion))
- Reliability of sensor measures(At the inclusion)
- Developement of dedicated algorithm to improve signal processing from IMU.(Day 1)