Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- 50th centile of stride velocity
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. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification.
The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.
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.
- •EDSS < or = à 5,5,
- •Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.
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)
结局指标
主要结局
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).
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).
Stance phase time
时间窗: 1 year
Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).
次要结局
未报告次要终点
研究者
Laurent Servais
Professor
Centre Hospitalier Universitaire de Liege