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临床试验/NCT03375346
NCT03375346已完成不适用

Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients

Samsung Medical Center0 个研究点目标入组 29 人开始时间: 2015年8月4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
29
主要终点
Cerebral cortex activity

研究概览

简要总结

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

详细描述

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.

Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

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 (Investigator)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral stroke with hemiplegia
  • 3 months after stroke onset
  • Able to walk at least 10 meters without assistive devices

排除标准

  • Subjects under 18 years and above 80 years old,
  • Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
  • Musculoskeletal disorders
  • Risk of falling due to dizziness
  • Pregnant women

研究组 & 干预措施

Whole body vibration group

Experimental

Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm.

干预措施: Whole body vibration (Device)

Whole body vibration group

Experimental

Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm.

干预措施: Exercise (Other)

Exercise only group

Active Comparator

The control group performed the same session without vibration.

干预措施: Exercise (Other)

结局指标

主要结局

Cerebral cortex activity

时间窗: check before, during and directly after intervention(for approximately 14 minutes)

cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS

次要结局

  • 10 meter walk test(before and after intervention(Approximately 14 minutes))
  • Fugl-Meyer Assessment(before and after intervention(Approximately 14 minutes))
  • Timed up and go test(before and after intervention(Approximately 14 minutes))
  • Tinetti Performance Oriented Mobility Assessment(before and after intervention(Approximately 14 minutes))

研究者

申办方类型
Other
责任方
Sponsor

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