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临床试验/NCT01414725
NCT01414725已完成不适用

Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.

University of Plymouth7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
7
主要终点
Change in 10 metre timed walk (10MTW)

研究概览

简要总结

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS).

详细描述

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS). The secondary aim is to determine the relative effectiveness of this 12 week Pilates based core stability training programme compared to a standardised physiotherapy exercise programme. Finally we intend to explore the underlying mechanisms of change associated with these exercise interventions by directly measuring changes in muscle thickness and activation in the deep abdominal core stabilising muscles of a sub-set of participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, 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

  • •Definite diagnosis of MS, according to McDonald's criteria
  • •Aged 18 years or over
  • •Able to walk independently with or without use of intermittent or constant unilateral assistance such as walking stick or orthotic brace

排除标准

  • •In relapse or relapse in previous three months
  • •Any medical condition contra-indicating participation in core stability exercises
  • •Score < 6 on the Abbreviated Mental Test, as an indicator of those whose cognitive difficulties could interfere with the informed consent process, or the ability to fully engage in the exercise programme.
  • •Current or recent (within past 6 months) participation in core stability exercises
  • •Current involvement in another interventional research study

研究组 & 干预措施

Relaxation

Placebo Comparator

干预措施: Relaxation (Other)

Standard Physiotherapy Exercises

Active Comparator

干预措施: Standard Physiotherapy Exercises (Other)

Core Stability Training

Experimental

干预措施: Core Stability Training (Other)

结局指标

主要结局

Change in 10 metre timed walk (10MTW)

时间窗: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

次要结局

  • Change in Multiple Sclerosis 12-item Walking Scale(baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up))
  • Change in Activities-specific Balance Confidence (ABC) Scale(baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up))
  • Change in Visual Analogue Scale (10 point) to determine "Difficulty in carrying a drink when walking".(baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up))
  • Change in Functional Reach - forwards and lateral(baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Freeman

Dr Jenny Freeman

University of Plymouth

研究点 (7)

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