- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05093491
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
The study is planned as a cross-sectional prospective study. Healthy volunteers and stroke patients who are planned to be hospitalized in the Stroke clinic for rehabilitation in Istanbul Physical Medicine Rehabilitation Training and Research Hospital are evaluated and included in the study according to the inclusion and exclusion criteria.
Demographic data of patients (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant extremity, stroke etiology, duration, side), functional status (Brunnstrom stages, Functional Ambulation Scale (FAS), Daily Living Activity (ADL) Index), Pulmonary Function Test (PFT) measurement results and bilateral diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography, demographic data of healthy volunteers (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant side), PFT measurement results and the dominant side diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography is done and included in the study.
In the ultrasonographic evaluation of the participants, using a 7-12 Mhz linear Probe, measurements are made of the diaphragm at the end of tidal expiration and forced inspiration, abdominal muscles at the end of tidal expiration and at the end of forced expiration, while all respiratory muscles are lying in the supine position. Diaphragm thickness is measured between the 8th and 9th ribs at the level of the anteroaxillary line, rectus abdominis; 4 cm lateral of the umbilicus, transversus abdominis, external oblique, internal oblique muscles' measurement is made from the middle of the lowest part of the 12. rib and the highest point of the iliac crest and 2.5 cm in front of the midaxillary line. All measurements are repeated 3 times and the average value will be recorded.
Vital capacity[VC], forced vital capacity [FVC], forced expiratory volume 1 second [FEV1] , FEV1/FVC, maximal expiratory flow rate [PEF], maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP] in patients' PFT ] measurement results are checked.
Intragroup and intergroup data are compared.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Istanbul, Truthahn
- İstanbul physical medicine rehabilitation training &research hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Ischemic or Hemorrhagic stroke patients
- Stroke duration >6 months
- Mini-mental test score >24
Exclusion Criteria:
- Individuals with acute or chronic lung disease
- Patients with a history of thoracic or abdominal surgery
- Patients with other neuromuscular diseases
- Aphasia type with impaired understanding
- Facial paralysis
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Querschnitt
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Stroke patients
Ultrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio of stroke patients.
Spirometry evaluation was performed by another investigator.
Diagnostic Test: Bilaterally diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography
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Ultrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio in the supine position in the stroke patient group.
The spirometric evaluation was also performed
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Healthy individuals
Ultrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio.
Spirometry evaluation was performed by another investigator.
Diagnostic Test: Dominant side diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography
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Ultrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio in the supine position in healthy individuals group.
The spirometric evaluation was also performed
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Diaphragma and Abdominal Muscle Thickness and thickening ratio
Zeitfenster: 1 day (a single point in time)
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Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement
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1 day (a single point in time)
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Forced vital capacity [FVC]
Zeitfenster: 1 day (a single point in time)
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>%80 is normal results
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1 day (a single point in time)
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Forced expiratory volume 1 second [FEV1]
Zeitfenster: 1 day (a single point in time)
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>%80 is normal results
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1 day (a single point in time)
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FEV1/FVC
Zeitfenster: 1 day (a single point in time)
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>%80 is normal results
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1 day (a single point in time)
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Maximal expiratory flow rate [PEF]
Zeitfenster: 1 day (a single point in time)
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>%80 is normal results
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1 day (a single point in time)
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Maximum inspiratory pressure [MIP],
Zeitfenster: 1 day (a single point in time)
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>80cmH2O is normal results
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1 day (a single point in time)
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Maximum expiratory pressure [MEP]
Zeitfenster: 1 day (a single point in time)
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>95cmH2O is normal results
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1 day (a single point in time)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Brunnstrom stages
Zeitfenster: 1 day (a single point in time)
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min 1 max 6, bigger values mean better results,
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1 day (a single point in time)
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Functional Ambulation Scale (FAS)
Zeitfenster: 1 day (a single point in time)
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min 0 max 5, bigger values mean better results,
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1 day (a single point in time)
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Daily Living Activity (ADL) Index
Zeitfenster: 1 day (a single point in time)
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min 0 max 100, bigger values mean better results,
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1 day (a single point in time)
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Yunus Emre Dogan, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
- Studienstuhl: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Misuri G, Colagrande S, Gorini M, Iandelli I, Mancini M, Duranti R, Scano G. In vivo ultrasound assessment of respiratory function of abdominal muscles in normal subjects. Eur Respir J. 1997 Dec;10(12):2861-7.
- Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
- Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
- Ishida H, Suehiro T, Kurozumi C, Ono K, Watanabe S. Correlation Between Abdominal Muscle Thickness and Maximal Expiratory Pressure. J Ultrasound Med. 2015 Nov;34(11):2001-5. doi: 10.7863/ultra.14.12006. Epub 2015 Sep 22.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FTRTEZDOGAN
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