Climate Influence on 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
- 60
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long term perspectives.
详细描述
Empirically, several patients with MS have reported improved function in warm climate during therapy or vacation. This is in contrast to the heat intolerance frequently reported in MS. Heat intolerance seems, however, to be individually distributed among the MS patients, and may seem to be related to the degree of warmth.
Sixty patients with gait problems and without heat intolerance were included in a cross-over study. They were randomized to a 4-week inpatient physiotherapy based on the Bobath concept in Norway or Spain, with cross-over the year after. Data from five physical performance measures and six self-reported measures were collected at screening, baseline, after treatment and three and six months after both treatment-periods. Change over time within groups and comparisons of change between groups were analyzed by mixed models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 60 years of age (both included).
- •Multiple sclerosis according to the McDonald criteria
- •Disability equivalent to Expanded Disability Status Score (EDSS) between 4.0 and 6.5 (both included)
- •Prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period.
- •Given written informed consent
排除标准
- •An active MS (attack or progression) during one month prior to inclusion or start of treatment.
- •Received treatment with glucocorticoids the last month prior to inclusion or start of treatment.
- •Excessive fatigue or severe cognitive dysfunction related to MS that would preclude safe participation in the protocol.
- •Suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol.
- •Heat intolerance.
- •Other serious concomitant disease that could preclude safe participation in the protocol.
- •Alcohol or drug abuse or consumption that could preclude participation according to the protocol and to attend the planned visits during the whole study period.
- •Breastfeeding or pregnancy
研究组 & 干预措施
Physiotherapy in Spain
Daily inpatient physiotherapy for four weeks in a warm climate
干预措施: Physiotherapy (Other)
Physiotherapy in Norway
Daily inpatient physiotherapy for four weeks in a cold climate
干预措施: Physiotherapy (Other)
结局指标
主要结局
6-minute walk test
时间窗: 2 years
次要结局
- Timed Up&Go(2 years)
- 10-metre timed walk(2)
- Berg Balance Scale(2)
- Trunk Impairment Scale(2)
- Borg's Rating of Perceived Exertion(2)
- Multiple Sclerosis Impact Scale (MSIS-29)(2)
- Fatigue Severity Scale(2)
- Numerical Rating Scale; gait, balance, pain(2)
- Modified Health Assessment Questionnaire(2)
- Patient Global Impression of Change(2)