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临床试验/NCT04188769
NCT04188769撤回不适用

Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

University Ghent1 个研究点 分布在 1 个国家开始时间: 2019年12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
1
主要终点
MyotonPRO measurement of pectoralis major muscle tone

研究概览

简要总结

The purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

详细描述

This study will be carried out in 20 persons with hypertonia following stroke. There will be one single test occasion, during which 6 test trials will be performed in random order. Deep pressure will be applied by means of a Johnstone air splint, that will be (1) not inflated, (2) inflated constantly, or (3) inflated intermittently. Each of these 3 inflation conditions will be performed twice, i.e. with and without a non-hemiplegic arm movement (triggering hypertonia at hemiplegic side).

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

性别
All
接受健康志愿者

入选标准

  • subacute stroke (<6 months)
  • hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)

排除标准

  • 未提供

结局指标

主要结局

MyotonPRO measurement of pectoralis major muscle tone

时间窗: through study completion, an average of 5 months

MyotonPRO measurement of pectoralis major muscle tone

heart rate

时间窗: through study completion, an average of 5 months

heart rate measurement assessed with the Zehpyr bioharness

heart rate variability

时间窗: through study completion, an average of 5 months

heart rate variability assessed with the Zehpyr bioharness

EMG of biceps brachii

时间窗: through study completion, an average of 5 months

electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side

respiratory rate

时间窗: through study completion, an average of 5 months

respiratory rate assessed with the Zehpyr bioharness

EMG of triceps brachii

时间窗: through study completion, an average of 5 months

electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side

EMG of pectoralis major

时间窗: through study completion, an average of 5 months

electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side

subjective rating of hypertonia

时间窗: through study completion, an average of 5 months

visual analogue scale rating of the intensity of hypertonia, in which the degree of hypertonia has to be situated between "0" (no hypertonia) and "10" (very severe hypertonia)

次要结局

  • MyotonPRO measurement of pectoralis major elasticity(through study completion, an average of 5 months)
  • MyotonPRO measurement of pectoralis major stiffness(through study completion, an average of 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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