NL-OMON32161已完成3 期
Positioning and electrical stimulation in stroke. - PAESIS-trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. A first ever or recurrent stroke except subarachnoid hemorrhages,
- •2. Age above 18,
- •3. Between 2 and 8 weeks post-stroke,
- •4. An apparent paralysis / severe paresis of the involved upper limb.
排除标准
- •1. Any of the following contra indications for electrical stimulation: metal implants in the involved arm or shoulder, cardiac pacemaker, thrombosis, (thrombo)phlebitis, cancerous lesions, skin infections on forearm or shoulder blade, epileptic seizures six months previous to and/or since the stroke, pregnancy and myasthenia gravis/myotonia,
- •2. Pre-existent impairments of the affected arm (e.g. peripheral neuropathy, frozen shoulder),
- •3. The ability to make selective movements of the hemiplegic arm (more than 18 points on the shoulder-and elbow sections of the Fugl-Meyer Assessment arm score),
- •4. Severe cognitive deficits and/or severe language comprehension difficulties (more than one of four questions wrong on the verbal items of the AbilityQ),
- •5. Severe neglect (a difference of more than three on the letter cancellation test),
- •6. Severe loss of pain sensation. This criterium is tested by administering electrical stimulation to the extensor muscles of the forearm arm of the subject. If a patient shows a good motor response during stimulation, but does not feel the stimulation, he/she is excluded if (any) skin irritation occurs after a test-session of 10 minutes using the parameters of the experimental procedure. Patients with severe loss of pain sensation who tolerate the test session well will, for extra safety purposes, receive checks after each electrical stimulation session during participation.
研究者
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