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临床试验/NCT05779293
NCT05779293招募中不适用

Effect of Vagus Nerve Stimulation on Chronic Stroke Patients

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Timed Get Up and Go Test

研究概览

简要总结

Stroke is still one of the top causes of death and adult-onset disability in the world.

Despite physiotherapy and rehabilitation, a sizable percentage of chronic stroke patients are permanently disabled. These neurological deficiencies include cognitive impairment, sensory impairment, loss of coordination, spasticity, dysphasia, dysphagia, visual field dysfunction, and weakness.

详细描述

Exercises, neurophysiological and electrical stimulations, compensatory strategies, strengthening facilitation approaches programs, and programs are all used as general approach methods in the rehabilitation of stroke patients.

Transcutaneous stimulation of the vagus nerve offers non-invasive stimulation of the vagus nerve and is commonly carried out by stimulating the auricular vagus nerve in the ear or transcutaneous cervical branch vagus in the neck.

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)

盲法说明

Evaluation and treatment will be carried out by different physiotherapists. In this way, it is aimed to provide an objective evaluation

入排标准

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

入选标准

  • To be between the ages of 18-
  • Having been diagnosed with a stroke by a neurologist.
  • Speech disorder after a cerebrovascular accident to be.
  • To volunteer to participate in the study.

排除标准

  • Being mentally affected (Mini-Mental Test Score <24).
  • Having other neurological diseases other than stroke.
  • Concomitant symptoms that prevent individuals from participating in the study (Having undergone amputation surgery, having cardiac arrhythmias be etc.)

结局指标

主要结局

Timed Get Up and Go Test

时间窗: 4 weeks

Getting out of the chair is in the form of walking back and forth 3 meters and sitting on the chair again. The aim is to measure the individual's time to complete this process. A high score indicates a high disability score.

The Modified Ashworth Scale,

时间窗: 4 weeks

The Modified Ashworth Scale, developed by Ashworth, is an international method used to evaluate the resistance encountered during passive muscle stretching in muscles with spasticity, which were later modified. It is rated at 6 levels from 0 to 4 to assess muscle tone. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extensio

Standardized Mini Mental State Test

时间窗: 4 weeks

The Mini Mental Test is a test that can be applied in outpatient clinic conditions or at the bedside in a period of 10 minutes by physicians, nurses and psychologists who have received a short training. It consists of eleven items gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, and is evaluated out of a total score of 30.Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

Brunstrom Hemiplegia Recovery Stages

时间窗: 4 weeks

Brunnstrom Score; It was used to evaluate motor recovery in the upper extremity, hand, and lower extremity, as well as to indicate which motor level the patient was at. Brunnstrom is a 6-digit scale containing progressively improving movement patterns for each area used

Berg Balance Scale

时间窗: 4 weeks

Berg Balance Scale is a scale developed to measure balance performance in geriatric people or geriatric patients. It is frequently used in clinical studies to evaluate postural control and to predict fall risk.scoring is between 0-51 points, with a high score indicating good balance.

Montreal Cognitive Assessment Scale

时间窗: 4 weeks

It was developed as a rapid screening test for mild cognitive impairment. These are; attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation and orientation. Montreal Cognitive Assessment Scale scores range between 0 and 30. It is between 0-30 points. A score of 21 and above is considered normal.A high score indicates a good cognitive level.

次要结局

  • Stroop test(4 weeks)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hazal genc

physiotherapist PhD

Istanbul Medipol University Hospital

研究点 (2)

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