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临床试验/NCT05550311
NCT05550311已完成不适用

The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke

Biruni University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Maximal inspiratory pressure

研究概览

简要总结

Stroke has a high rate of morbidity and mortality worldwide. This disease is the third leading cause of death after ischemic heart disease and cancer. Stroke is also the leading cause of disability in adults. It is known that stroke individuals have not only limb restriction, but also respiratory capacity and exercise capacity. It has been shown in the literature that upper extremity functions are directly related to respiratory capacity. Although it is known that upper extremity training has positive effects on respiratory capacity in stroke individuals, more studies are needed to examine the effects of upper extremity robot-assisted rehabilitation on respiratory capacity. The aim of this study is to examine the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity.

详细描述

One of the most common complications in stroke patients is pulmonary aspiration and pneumonia, which are associated with respiratory functions being affected. Fluoroscopic examinations of stroke patients showed decreased movement in the diaphragm as well as in other muscles on the affected side. The combination of a decrease in respiratory parameters, weakness in respiratory muscles, and a decrease in diaphragmatic activity can cause dyspnea in individuals even that require minimal effort. The low level of physical activity is accompanied by a decrease in respiratory functions, and the participation of individuals in society decreases. The purpose of stroke rehabilitation is to reduce the complications caused by stroke and to increase the individual's psychological, social, physical, and professional level of independence and functionality to the highest level. Nowadays, stroke rehabilitation can be shaped by a variety of methods. In clinics, robotic rehabilitation is commonly used for stroke patients with the development of the technology. In the literature, studies show the effect of robotic rehabilitation on respiratory parameters, also robot-assisted walking training provides significant improvement in some respiratory parameters and increases aerobic capacity. The aim of this study is to evaluate the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity in individuals with stroke.

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 (Outcomes Assessor)

盲法说明

The assessor will be blind to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-65,
  • Diagnosed with hemorrhagic or ischemic stroke,
  • Having a stroke history of at least 3 months,
  • Being 16 and above according to the Mini-Mental State Test,
  • Three and above according to the Brunnstrom stage,
  • Individuals not included in another rehabilitation program will be included.

排除标准

  • Chronic cardiac or pulmonary diseases such as COPD, asthma, interstitial lung disease, and heart failure,
  • Using tobacco and tobacco products,
  • Severe spasticity to prevent robotic rehabilitation (on Modified Ashworth Scale,
  • With skin ulcers,
  • Non-union or unstable fracture status,
  • Individuals with pressure sores will not be included.

结局指标

主要结局

Maximal inspiratory pressure

时间窗: Change from Baseline Maximal inspiratory pressure at 6 weeks

Mouth pressure will be assessed to document inspiratory muscle strength

Peak Expiratory Flow Rate

时间窗: Change from Baseline Peak Expiratory Flow Rate at 6 weeks

Spirometric assessment will be performed to determine participants' peak expiratory flow rate.

Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio

时间窗: Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks

Spirometric evaluation will be performed to determine the FEV1/FVC value of the participants.

Maximal expiratory pressure

时间窗: Change from Baseline Maximal expiratory pressure at 6 weeks

Mouth pressure will be assessed to document expiratory muscle strength

次要结局

  • Peak cough flow(Change from Baseline Peak cough flow at 6 weeks)
  • Dyspnea-12 Scale(Change from Baseline Dyspnea-12 Scale at 6 weeks)
  • 6 Minutes Walking Test(Change from Baseline 6 Minutes Walking Test at 6 weeks)
  • Time Up and Go Test(Change from Baseline Time Up and Go Test at 6 weeks)
  • Satisfaction survey(At 6 weeks)

研究者

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

Buket AKINCI

Assoc.Prof.

Biruni University

研究点 (2)

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