Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point
研究概览
简要总结
ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS.
The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.
详细描述
On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.
Participants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale).
Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •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
Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point
时间窗: 1 year
95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Difference in 50th centile of stride length between baseline and one year follow up- or last time point
时间窗: 1 year
50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point
时间窗: 1 year
50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Difference in 95th centile of stride length between baseline and one year follow up- or last time point
时间窗: 1 year
95th 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
Professor
Centre Hospitalier Universitaire de Liege