Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of the strength and fatigue
研究概览
简要总结
The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.
详细描述
Single center, retrospective and prospective study.
In order to assess the efficiency of the of usual rehabilitation proposed to patients in the day hospital, assessments are systematically performed before and after the rehabilitation program:
- Assessment of muscular strength and fatigue:
Assessments of voluntary force will be those usually performed in the context of the evaluation of patients. The isokinetic dynamometer CON-TREX ® is a device that provides a quantified result of the torque developed in a predetermined joint area with a constant speed which is also defined in advance.
The assessment includes an assessment of the strength in isometric contraction (at 40 and 90 degrees of knee flexion) and concentric contraction (30, 60 and 90 degrees per second). Fatigue is evaluated by two self-administered questionnaires: the Fatigue Severity Scale and Modified Fatigue Impact Scale. 2. Effort test:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis with EDSS ≤ 6 (Expanded Disability Status Scale)
- •Patient ≥ 18 years old
- •Patient able to comply with the recommended monitoring
- •No relapse within the last three months
- •More than six months elapsed since last medical care in day hospital
- •No recent modification (six month) of medications for MS
- •More than three months elapsed since last change of associated treatments (Fampyra, botulinum toxin)
排除标准
- •Patients under any form of guardianship or curatorship
- •Breastfeeding
- •Orthopedic complications with repercussions on walking activities
- •No affiliation to a social security scheme (beneficiary or assignee)
结局指标
主要结局
Assessment of the strength and fatigue
时间窗: Within 10 weeks from the start of the rehabilitation program
Assessment realised with an isokinetic dynamometer
次要结局
- 10 meters Walk test(Within 10 weeks from the start of the rehabilitation)
- Timed up and go test(Within 10 weeks from the start of the rehabilitation)
- Assessment of Spasticity with the Modified Ashworth Scale (MAS),(Within 10 weeks from the start of the rehabilitation program)
- Time to ascend and descend stairs(Within 10 weeks from the start of the rehabilitation)
- 6 minutes walking test(Within 10 weeks from the start of the rehabilitation program)
- Evaluation of aerobic capacity during an effort test(Within 10 weeks from the start of the rehabilitation program)
- Assessment of the balance of patients(Within 10 weeks from the start of the rehabilitation)
- Assessment of Strength with the Medical Research Council (MRC),(Within 10 weeks from the start of the rehabilitation)
- Assessment of Quality of Life with SEP-59 Scale(Within 10 weeks from the start of the rehabilitation)