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临床试验/NCT01810562
NCT01810562撤回不适用

Study on Effect of Tactile Stimulation on Reduced Sensibility of the Affected Extremities After Stroke.

Vestre Viken Hospital Trust2 个研究点 分布在 1 个国家开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Weinstein Enhanced sensory test (WEST)

研究概览

简要总结

The purpose of this study is to determine whether tactile stimulation for reduced sensibility of the affected extremities after stroke has effect.

Hypothesis:

Stimulation of sensibility after stroke will have a significant contribution for improved sensibility. Without any stimulation, no signal is sent to the brain and there is no need for the healthy parts of the brain to adapt this function. Stimulation of the sensibility over a period of time on both sides of the body, gives the brain signals and the opportunity to compare how the signals should be recognized. New connection will be able to interpret signals correctly.

详细描述

Through stroke rehabilitation, function from damaged areas can be replaced by healthy parts of the brain. It is important for rehabilitation to take advantage of this compensatory qualities whit early intervention and mobilization. Only small gains can lead to big improvements.

About half of stroke survivors gets reduced sensibility caused bye the stroke, and sensibility is considered to be an important part of rehabilitation of function and activities.

A Norwegian guideline concludes that the scientific knowledge is to week to recommend this kind of treatment. There is some evidence for improvement of sensibility when specific training and stimulation is given. Achievements in sensibility can lead to some improvement in function.

The project will be carried out as a randomized controlled trial. In this project, the intervention group receive tactile senses stimulated twice daily over a period of 3 months, while the control group receives standard treatment. The results from both groups are measured before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Single (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

入选标准

  • Patients with impaired tactile sensitivity after stroke Kongsberg hospital to undergo rehabilitation course.

排除标准

  • Patients with a history of stroke.
  • Patients with significant symptomatic additional diseases, such as neuropathy.
  • Patients who cannot provide adequate response if they can feel the touch.
  • Terminal and palliative care patients.
  • Patients with cancer.
  • Patients with hypertonic muscles in the current body area.
  • Patients below 18 years of age

结局指标

主要结局

Weinstein Enhanced sensory test (WEST)

时间窗: Change within 3 days after the patient has been hospitalized to 3 months

Measurement of defined points on the arms and legs.

次要结局

  • Disk-Criminator(Change from 3 days after the patient has been hospitalized to 3 months)
  • NIH Stroke Scale (NIHSS)(Change from Baseline to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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