- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05093491
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Istanbul, Tacchino
- İstanbul physical medicine rehabilitation training &research hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Diaphragma and Abdominal Muscle Thickness and thickening ratio
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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],
Lasso di tempo: 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]
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Brunnstrom stages
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Yunus Emre Dogan, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
- Cattedra di studio: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
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