Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 主要终点
- Brain activity
研究概览
简要总结
Imaging methods bring new possibilities for describing the brain plasticity processes that underly the improvement of clinical function after physiotherapy in people with multiple sclerosis (pwMS). The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.
详细描述
The study was designed as parallel group randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
MS patients were examined by fMRI (primary outcomes) and clinical tests (secondary outcomes) at the beginning of study. Then, they were randomly divided into two groups (by drawing lots in a 1:1 ratio). The first group underwent Vojta reflex locomotion (VRL), and the second Motor Program Activating Physiotherapy (MPAT). The length and intensity of treatment was the same in both groups (two months, one hour twice a week). After the treatment, a clinical and fMRI examination was performed. Healthy volunteers underwent an fMRI examination that was considered to be a control.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •definite MS
- •stable clinical status in the preceding 3 months
- •imuno-modulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab)
- •Expanded Disability Status Scale (EDSS)≤6
- •predominant motor impartment
- •six months or more without any physiotherapy
- •ability to undergo ambulatory physiotherapy
- •Exlusion criteria:
- •other neurological disease or conditions disabling movement
排除标准
- 未提供
结局指标
主要结局
Brain activity
时间窗: 0 and 2 months
fMRI examinations on 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel head coil (different pattern of brain activity before and after two months of physiotherapeutic program)
次要结局
- Paced Auditory Serial Addition Test - PASAT(2 months)
- Berg Balance Scale - BBS(2 months)
- Timed 25 Foot Walk - T25FW(2 months)
- Timed Up and Go - TUG(2 months)
- Nine Hole Peg Test - NHPT(2 months)
研究者
Kamila Řasová
assoc. prof. Kamila Řasová, Ph.D.
Charles University, Czech Republic