Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clustering analyze based on IGP
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. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).
详细描述
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 previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
- •Over 18 years old /age greater than 18 years
- •Patients followed at Nantes university hospital or Rennes university hospital
- •Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion
- •No relapse within 3 months
- •With a Medullar MRI planed as part as usual care
- •MRI scan can be performed within a maximum of 4 months after or before the walking test.
- •Affiliated person or beneficiary of a social security scheme
排除标准
- •Bilateral aid needed to walk
- •Women who are pregnant
- •Patient having expressed their opposition
- •Patient under guardianship or security measure
结局指标
主要结局
Clustering analyze based on IGP
时间窗: At the inclusion
IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle (0-1).
Clustering analyze based on EDSS score
时间窗: At the inclusion
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.
Clustering analyze based on MRI lesion load
时间窗: At the inclusion
MRI characteristics are spinal and extraspinal lesion volumes.
次要结局
- Correlation with disability(At the inclusion)
- Correlation with MRI lesion load(At the inclusion)
- Building a predictive model for lesion load involving in walk ability from IGP(At the inclusion)
- Building a predictive model for group belonging from group established in main outcome based on IGP(At the inclusion)