Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- 95th centile of stride length
研究概览
简要总结
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.
This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Confirmed MS diagnosis,
- •Over 18 years old,
- •Ambulant patients,
- •Signed informed consent,
- •No clinical and / or radiological relapse within 3 months.
排除标准
- •Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
- •Any other previous or present pathology having an impact on motor function.
- •Recent surgery or trauma (less than 6 months) in the upper or lower limbs
研究组 & 干预措施
MS patients
Ambulant patients with multiple sclerosis
干预措施: Actimyo° (Device)
MS patients
Ambulant patients with multiple sclerosis
干预措施: IMU (Device)
结局指标
主要结局
95th centile of stride length
时间窗: One day
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
95th centile of stride velocity
时间窗: One day
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
50th centile of stride length
时间窗: One day
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
50th centile of stride velocity
时间窗: One day
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Stance phase time
时间窗: One day
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
次要结局
未报告次要终点
研究者
Laurent Servais
Principal investigator
Centre Hospitalier Universitaire de Liege