Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters
調査の概要
状態
条件
詳細な説明
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.
The study is designed as a single-center, controlled cross-sectional observational study. A minimum of 40 individuals with stroke and 25 healthy volunteers will be enrolled. Associations between ultrasonographic respiratory muscle measurements and clinical parameters will be analyzed to improve understanding of respiratory muscle involvement after stroke and its relationship with functional outcomes.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ozge Kenis Coskun
- メール：ozgekenis@gmail.com
研究連絡先のバックアップ
- 名前：Oguzhan Kasimoglu
- 電話番号：+905448911835
- メール：kasimogluoguzhan@gmail.com
研究場所
-
-
Maltepe
-
Istanbul、Maltepe、トルコ（Türkiye）、34854
- Marmara Üniversitesi Tıp Fakültesi
-
コンタクト：
- Secretary General Secretary
- 電話番号：+90 2166254545
- メール：ozgekenis@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria (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.
Exclusion Criteria (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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Group 1: Stroke Patients
Adults aged 18-75 years with a history of ischemic or hemorrhagic stroke who meet the study eligibility criteria.
A minimum of 40 participants will be enrolled in this group.
|
|
Group 2: Healthy Controls
Age-eligible healthy volunteers without a history of stroke, neurological disease, chronic respiratory disease, chest wall deformity, or systemic disease affecting muscle function.
A minimum of 25 participants will be enrolled in this group.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
時間枠：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.
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parasternal Intercostal Muscle Thickness
時間枠：Baseline
|
Ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.
|
Baseline
|
|
Intercostal Muscle Asymmetry Index
時間枠：Baseline
|
Intercostal Muscle Asymmetry Index (AI) is a normalized measure of side-to-side differences in parasternal intercostal muscle contractility.
The asymmetry index is calculated using the formula |TF₁ - TF₂| / [(TF₁ + TF₂)/2] × 100, where TF represents the intercostal muscle thickening fraction measured by ultrasonography.
Higher values indicate greater asymmetry between the two sides, whereas lower values indicate more symmetrical intercostal muscle function.
|
Baseline
|
|
Relative Hemiplegic Deficit
時間枠：Baseline
|
Relative Hemiplegic Deficit is a measure of the reduction in parasternal intercostal muscle contractility on the hemiplegic side relative to the non-hemiplegic side in individuals with stroke.
It is calculated using the formula [(TFnon-hemiplegic - TFhemiplegic) / TFnon-hemiplegic] × 100, where TF represents the intercostal muscle thickening fraction measured by ultrasonography.
Higher values indicate a greater functional deficit of the hemiplegic side, while lower values indicate more preserved intercostal muscle function.
|
Baseline
|
|
Diaphragm Thickening Fraction
時間枠：Baseline
|
Diaphragm contractility assessed by ultrasonography.
Thickening fraction is calculated as [(Thickness at maximal inspiration - Thickness at end-expiration) / Thickness at end-expiration] × 100.
Higher values indicate greater diaphragm contractile function.
|
Baseline
|
|
Maximal Inspiratory Pressure (MIP)
時間枠：Baseline
|
Maximum inspiratory pressure (MIP) is a measurement that evaluates the strength of the inspiratory muscles.
This test measures the negative pressure created when a person breathes in at maximum effort.
MIP assesses the strength of respiratory muscles, such as the diaphragm and intercostal muscles, and is used to diagnose conditions characterized by respiratory muscle weakness.
|
Baseline
|
|
Maximal Expiratory Pressure (MEP)
時間枠：Baseline
|
Maximum expiratory pressure (MEP) is a measurement that evaluates the strength of the expiratory muscles.
This test measures the positive pressure generated when a person exhales with maximum effort.
MEP assesses the strength of expiratory muscles, including the abdominal and internal intercostal muscles, and is commonly used to evaluate respiratory muscle function and identify conditions associated with expiratory muscle weakness.
Higher values indicate greater expiratory muscle strength.
|
Baseline
|
|
Fugl-Meyer Assessment Score
時間枠：Baseline
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific impairment scale used to evaluate motor recovery after stroke.
The motor domain score ranges from 0 to 100 points, with higher scores indicating better motor function and less motor impairment.
|
Baseline
|
|
Berg Balance Scale Score
時間枠：Baseline
|
The Berg Balance Scale (BBS) consists of 14 tasks assessing static and dynamic balance.
Scores range from 0 to 56 points.
Higher scores indicate better balance performance and lower fall risk, whereas lower scores indicate greater balance impairment.
|
Baseline
|
|
Functional Independence Measure (FIM) Score
時間枠：Baseline
|
The Functional Independence Measure assesses the level of disability and functional independence in activities of daily living.
Total scores range from 18 to 126 points.
Higher scores indicate greater independence and lower levels of assistance required.
|
Baseline
|
|
Stroke-Specific Quality of Life (SS-QoL) Score
時間枠：Baseline
|
Stroke-Specific Quality of Life Scale (SS-QoL) is used to assess the life expectancy of a stroke survivor.
It is specifically designed for individuals who have had a stroke.
Both personal and psychosocial effects are assessed collectively.
Scores range from 49-245.
Higher scores indicate better functioning.
|
Baseline
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。