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临床试验/NCT00184431
NCT00184431已完成不适用

A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2004年4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
62
试验地点
1
主要终点
The Berg Balance Scale

研究概览

简要总结

The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.

详细描述

Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another.

Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.

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 (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Admitted to the stroke unit with a diagnosis of stroke
  • •Living in the city of Trondheim
  • •Included 4 - 14 days after first sign of symptoms
  • •Modified Rankin Scale > 3 before admission to hospital
  • •Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points
  • •SSS leg item less than 6 points or SSS movement item less than 12 points
  • •Discharged to home or a rehabilitation clinic
  • •Mini Mental State Examination Score more than 20 points
  • •Able and willing to provide informed consent

排除标准

  • •Seriously heart- and lung-diseases
  • •Other diseases which makes it difficult to evaluate the function
  • •Already included in the trial

研究组 & 干预措施

A

Experimental

Intensive task specific balance training

干预措施: Physical therapy technique and exercises (Behavioral)

B

Active Comparator

Traditional physical therapy

干预措施: Physical therapy technique and exercises (Behavioral)

结局指标

主要结局

The Berg Balance Scale

时间窗: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up

次要结局

  • Mini Mental State Examination(Inclusion)
  • Scandinavian Stroke Scale(Inclusion)
  • Motor Assessment Scale(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Timed Up and Go(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Step Test(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Walking speed(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Barthel Index(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Modified Rankin Scale(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Fall Efficacy Scale(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)
  • Stroke Impact Scale(Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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