Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline Movement skills score at 12 weeks and 6 months
研究概览
简要总结
The aim of the study is to determine the benefits of outpatient group rehabilitation with subsequent telerehabilitation. The patient will participate in a 12-week circuit training, including training once a week in a group of six under the guidance of two physiotherapists. After the outpatient rehabilitation, the patient will gain access to a mobile application and will be asked to record all physical activities there.
详细描述
In the Czech population more than 20,000 people have been diagnosed with multiple sclerosis (MS), an autoimmune disease affecting a patient's central nervous system. This disease has a wide range of symptoms, with the most common ones being various motor disorders that negatively affect the locomotor function and patients' quality of life.
The positive effect of physical activity on human health is well known. This study aims to examine the effect of hybrid exercise program on people with MS. This exercise program includes ambulatory circuit training for twelve weeks followed by telerehabilitation. The aim of the study is to find out whether the exercise program will positively affect the movement skills of probands and improve their quality of life. Testing will done before the start of the exercise program, after twelve weeks and after 6 months. Movement skills will be tested by a set of movement tests called miniBEST test. For measuring quality of life the investigators will the SF-36 questionnaire will be used. Another goal will analyze participants' satisfaction with the intervention and adherence to regular physical activity.
The investigators anticipate that regular physical training combined with telerehabilitation will increase the motivation and effectiveness of independent training in people with MS leading to improvment of physical fitness, physical activity levels and quality of life.
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
- Single (Outcomes Assessor)
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 diagnosis of Multiple Sclerosis based on McDonald criteria
- •Minimal one month from last relapse
- •Possibility to use smartphone or tablet because of using rehabilitation application
排除标准
- •Illnesses which can limiting exercises activities (e.g. orthopedic, cardiology or other neurological diseases)
- •Cognitive deficit which can limiting cooperation (fill a questionnaire, comply with movement task, using application)
- •Relapse of diseases during study
结局指标
主要结局
Change from Baseline Movement skills score at 12 weeks and 6 months
时间窗: Baseline, 12 weeks, 6 months
Mini Balance Evaluation Systems Test (Mini BESTest) - 14-item scale for measure postural stability. Maximum value is 28 points, minimum value is 0 point. Higher scores mean a better outcome.
次要结局
- Change from Baseline Walking skills score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
- Change from Baseline Depression score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
- Change from Baseline Health related quality of life score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
- Exercise adherence(6 months)
研究者
Ladislav Batalik
Principal Investigator
Brno University Hospital