Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Change from baseline in Berg Balance Scale at 8 weeks
研究概览
简要总结
The study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain a further 7 weeks post training.
Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural balance are often affected early in the course of the disease. The risk of falls is large. Many persons with MS have decreased trunk stability compared to healthy persons . In an earlier study including people with mild to moderate MS we found that a period of core stability exercises reduced the risk of falls. In this study the training concept will be applied for persons with more severe walking limitations.
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
- Single (Investigator)
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
- •diagnosed multiple sclerosis
- •Expanded Disability Scale Score of 5-6.5
- •walking speed of less than 0.8 m/s as tested on a 10 meter walking test
排除标准
- •Ongoing relapse
- •Cognitive or language difficulties that prohibit participating in the intervention or performing the outcome measures
- •Change in specific MS medication during the last 30 days
结局指标
主要结局
Change from baseline in Berg Balance Scale at 8 weeks
时间窗: baseline, 8 weeks
次要结局
- Change from baseline on the Falls-Efficacy scale at 8 weeks(baseline, 8 weeks)
- Change from baseline in 10 repetitions Sit to stand test at 15 weeks(baseline, 15 weeks)
- Change from baseline in Trunk Impairment scale at 8 weeks(baseline, 8 weeks)
- Change from baseline in the Trunk Impairment Scale at 15 weeks(baseline, 15 weeks)
- Change from baseline in the 10 repetition Si to stand test at 8 weeks(baseline, 8 weeks)
- Change from baseline in the Berg Balance scale at 15 weeks(baseline, 15 weeks)
- Change from baseline on the Timed Up and Go test at 8 weeks(baseline, 8 weeks)
- Change from baseline on the Timed Up and Go test at 15 weeks(baseline, 15 weeks)
- Change from baseline on the10 meter walking test at 8 weeks(baseline, 8 weeks)
- Change from baseline on the 10 meter walking test at 15 weks(baseline, 15 weeks)
- Change from baseline on the 2 minutes walking test at 8 weeks(baseline, 8 weeks)
- Change from baseline on the 2 minutes walking test at 15 weeks(baseline, 15 weeks)
- Change from baseline in postural sway at 8 weeks(baseline, 8 weeks)
- Change from baseline in postural sway at 15 weeks(baseline, 15 weeks)
- Change from baseline on the Falls Efficacy scale at 15 weeks(baseline, 15 weeks)
- Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks(baseline, 8 weeks)
- Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks(baseline, 15 weeks)
- Change from baseline on the MS Walking Scale-12 at 8 weeks(baseline, 8 weeks)
- Change from baseline on the MS Walking scale-12 at 15 weeks(baseline, 15 weeks)
- The number of falls and accidental falls(from baseline to 15 weeks)
研究者
Anette Forsberg, PhD
PhD, lecturer
Örebro County Council