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临床试验/NCT03763019
NCT03763019已完成不适用

Correlation of Pulmonary Function Test and Ultrasonographic Diaphragm Measurements in Patients With Hemiplegia and Investigation of the Effects of Respiratory Exercises on These Parameters

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Tiffeneau-Pinelli index

研究概览

简要总结

This study evaluates the effects of respiratory exercises on respiratory function test parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients will receive respiratory and neurophysiological exercises, while other half will receive only neurophysiological exercises.

详细描述

After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the other muscles of the affected side.

Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness of diaphragm in maximum expiration and inspiration thus examining the functionality of the muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has been proven in recent literature. In this manner, the aim of this study is twofold. First is to determine whether ultrasonography can be used practically to evaluate the respiratory functions of the patients after stroke. Respiratory function tests will be used for the correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via diaphragm ultrasonography and respiratory function tests.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke confirmed radiologically
  • Unilateral hemiplegia
  • First stroke episode
  • Mini Mental score ≥ 24

排除标准

  • Unable to consent and understand
  • Chronic cardiac disease
  • Pulmonary disease (asthma, restrictive or obstructive pulmonary disease)
  • Facial paralysis
  • History of thoracic or abdominal surgery
  • Being alcoholic
  • Using psychotropic drugs

结局指标

主要结局

Tiffeneau-Pinelli index

时间窗: 6 weeks

A calculated ratio used in the diagnosis of obstructive and restrictive lung disease. Calculated as FEV1/FVC. \>80% is normal. ≤80% indicates an obstructive pulmonary disease.

Diaphragmatic thickening fraction (TF)

时间窗: 6 weeks

Thickness of the diaphragm is measured from the zone of apposition (subcostal area between anterior axillary line and mid-axillary line) via ultrasonography. After diaphragm thickness in end expiration (thickness in functional residual capacity- TFRC) and in end inspiration (thickness in total lung capacity- TTLC) are obtained. Thickening fraction is calculated as \[TTLC-TFRC/TFRC\]x100. A higher value shows a better outcome.

Forced expiratory volume in one second (FEV1)

时间窗: 6 weeks

The maximal amount of air you can forcefully exhale in one second. Measured by spirometry. \>80% is normal. If there is an obstruction, this measurement shows the severity of the obstruciton. The lower values show a poorer outcome.

Forced expiratory flow at 25% and 75% (FEF 25-75%)

时间窗: 6 weeks

The average forced expiratory flow during the mid (25% - 75%) portion of the FVC. Shows small and medium airway obstruction. \>70% is normal. It shows the small airways impariment

Forced vital capacity (FVC)

时间窗: 6 weeks

The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measured by spirometry. \>80% is normal. If the value is lower than the normal limit it indicates either an obstructive or restrictive disease. The lower values show a poorer outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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