Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Parasternal Intercostal Muscle Thickening Fraction (ICTf)
研究概览
简要总结
The aim of this study is to evaluate the morphological and functional characteristics of parasternal intercostal muscles in patients with stroke using ultrasonography. Parasternal intercostal muscle thickness and thickening fraction will be assessed on both the hemiplegic and non-hemiplegic sides. The relationship between ultrasonographic findings and respiratory muscle strength, motor function, balance, functional independence, and quality of life will also be investigated. A healthy control group will be included to establish reference values and enable comparative analyses.
详细描述
Stroke frequently leads to respiratory muscle dysfunction due to impaired central motor control. Although diaphragm involvement after stroke has been extensively investigated, there is limited evidence regarding the morphological and functional characteristics of extra-diaphragmatic inspiratory muscles, particularly the parasternal intercostal muscles.
The primary objective of this study is to evaluate parasternal intercostal muscle morphology and contractility in individuals with stroke using ultrasonography. Parasternal intercostal muscle thickness will be measured at end-tidal expiration and maximal inspiration, and intercostal muscle thickening fraction (ICTf) will be calculated as an indicator of muscle contractility. Measurements will be obtained bilaterally, allowing comparison between the hemiplegic and non-hemiplegic sides.
In addition, diaphragm thickness and diaphragm thickening fraction will be assessed using ultrasonography. Respiratory muscle strength will be evaluated by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements according to ATS/ERS recommendations. Pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC ratio will also be performed.
Clinical outcomes including motor impairment, balance, functional independence, and stroke-specific quality of life will be assessed using the Fugl-Meyer Assessment, Berg Balance Scale, Functional Independence Measure (FIM), and Stroke-Specific Quality of Life Scale (SS-QoL), respectively.
A healthy control group matched for age, sex, and body mass index will be included to establish reference values for parasternal intercostal muscle ultrasonographic measurements and to allow comparative analyses between stroke patients and healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Stroke Group):
- •Age between 18 and 75 years.
- •History of ischemic or hemorrhagic stroke.
- •Ability to understand and comply with study procedures.
- •Provision of written informed consent.
排除标准
- •(Stroke Group):
- •Presence of acute or chronic pulmonary disease.
- •History of thoracic or abdominal surgery.
- •Presence of another neuromuscular disorder.
- •Aphasia or cognitive impairment preventing participation in assessments.
- •Active malignancy.
- •Inclusion Criteria (Healthy Control Group):
- •Age between 18 and 75 years.
- •Willingness to participate in the study.
- •Provision of written informed consent.
- •Exclusion Criteria (Healthy Control Group):
- •History of stroke or other neurological disorders.
- •History of chronic respiratory disease (e.g., COPD, asthma).
- •Chest wall deformity.
- •Presence of systemic diseases that may affect muscle function.
结局指标
主要结局
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
时间窗: Baseline
Ultrasonographic assessment of parasternal intercostal muscle contractility. Thickening fraction will be calculated as: (Inspiratory Thickness - Expiratory Thickness) / Expiratory Thickness × 100. Higher values indicate greater inspiratory muscle contractile activity. Comparison will be performed between the hemiplegic and non-hemiplegic sides.
次要结局
- Parasternal Intercostal Muscle Thickness(Baseline)
- Intercostal Muscle Asymmetry Index(Baseline)
- Relative Hemiplegic Deficit(Baseline)
- Diaphragm Thickening Fraction(Baseline)
- Maximal Inspiratory Pressure (MIP)(Baseline)
- Maximal Expiratory Pressure (MEP)(Baseline)
- Fugl-Meyer Assessment Score(Baseline)
- Berg Balance Scale Score(Baseline)
- Functional Independence Measure (FIM) Score(Baseline)
- Stroke-Specific Quality of Life (SS-QoL) Score(Baseline)