- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05093491
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Pavo
- İstanbul physical medicine rehabilitation training &research hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diaphragma and Abdominal Muscle Thickness and thickening ratio
Periodo de tiempo: 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]
Periodo de tiempo: 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]
Periodo de tiempo: 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
Periodo de tiempo: 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]
Periodo de tiempo: 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],
Periodo de tiempo: 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]
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brunnstrom stages
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Yunus Emre Dogan, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
- Silla de estudio: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FTRTEZDOGAN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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