A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.
详细描述
This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and M6) each patient will be tested for the primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age 18 year or over
- •Able to walk independently without use of assistance 200 meters Expanded Disability Status Scale ≤5
- •No relapse within the last three months
- •No current or recent (six months) participation in intensive rehabilitation
- •No recent modification (six months) of medications for MS
- •Patients who received and signed information and informed consent
排除标准
- •Cognitive impairments which could interfere with the ability to fully engage the rehabilitation program.
- •Recent involvement (three months) in another interventional research study
- •A complicating medical condition or orthopedic diagnosis that limits rehabilitation
- •Cardiac or respiratory disease that interfere with endurance training
- •Patient with safety measure
- •Pregnant women, breastfeeding
- •No affiliation to a social security
研究组 & 干预措施
Combined program
Combined program with physiotherapy, endurance training and resistance training.
120 patients will receive this combined program
干预措施: Combined program (Behavioral)
Physiotherapy
Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation
干预措施: Physiotherapy in private practice (Behavioral)
结局指标
主要结局
6 Minute Walk Test
时间窗: 6 Minutes
6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
次要结局
- Strength and fatigue of the knee flexors and extensors(45 min)
- Quality of Life assessment(55 min)
- Aerobic capacity(1h)
- Functional tests(20 Minutes)
- Clinical assessment(45 min)
- Balance (Berg Balance scale) and postural control assessment(15 min)