Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- Stride velocity
研究概览
简要总结
The objective of the ActiLiège Next study is to collect longitudinal data from patients and control subjects using a wearable magneto-inertial device. By collecting natural history data in various neuromuscular disorders (Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy), we aim to validate digital outcome measures to continuously assess motor function in real-life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •For the patients:
- •Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed.
- •Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs (for ambulant patients).
- •A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
- •Patients who are participating in an interventional clinical trial.
- •DMD patients in transition who are not on corticosteroids.
- •For the control subjects:
- •Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs.
- •Elite athletes (at the national level).
- •A chronic or acute muscular, neurological, infectious, or inflammatory pathology within the 3-week period immediately prior to inclusion.
- •An orthopedic, neuromuscular, or neurological pathology that affects the quality of the subject's walking gait.
结局指标
主要结局
Stride velocity
时间窗: through study completion (3 year)
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Stride length
时间窗: through study completion (3 year)
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Stairs height
时间窗: through study completion (3 year)
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs speed
时间窗: through study completion (3 year)
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs number
时间窗: through study completion (3 year)
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
次要结局
未报告次要终点
研究者
Laurent Servais
Professor Laurent Servais
Centre Hospitalier Universitaire de Liege