Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- 95th centile of stride length
研究概览
简要总结
ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS.
The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.
They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r).
After each visit, participants will wear Actimyo for one month daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.
- •Over 18 years old.
- •Signed informed consent
- •If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.
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.
- •Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.
- •Patients participating in an interventional clinical trial.
结局指标
主要结局
95th centile of stride length
时间窗: 1 year
95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
95th centile of stride velocity
时间窗: 1 year
95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
50th centile of stride velocity
时间窗: 1 year
50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
50th centile of stride length
时间窗: 1 year
50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
次要结局
- Upper limb function evolution in patient with ALS(1 year)
研究者
Laurent Servais
Coordinator of reference center for neuromuscular diseases
Centre Hospitalier Universitaire de Liege