Clinical trial NCT05093491: Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients
Official title: Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Muscle
Pulmonary Function Test
Keywords: stroke
pulmonary function
ultrasound
respiratory muscle thickness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-26
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients and, healthy volunteers which have close demographic data with stroke patients

Brief summary: Ultrasonographic evaluation of respiratory muscle thickness in stroke patients, determination of its correlation with pulmonary function test (PFT) , and the first evaluation method to determine respiratory rehabilitation goals and to use it in the follow-up of the effectiveness of the treatment.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diaphragma and Abdominal Muscle Thickness and thickening ratio
timeFrame: 1 day (a single point in time)
measure: Forced vital capacity [FVC]
timeFrame: 1 day (a single point in time)
measure: Forced expiratory volume 1 second [FEV1]
timeFrame: 1 day (a single point in time)
measure: FEV1/FVC
timeFrame: 1 day (a single point in time)
measure: Maximal expiratory flow rate [PEF]
timeFrame: 1 day (a single point in time)
measure: Maximum inspiratory pressure [MIP],
timeFrame: 1 day (a single point in time)
measure: Maximum expiratory pressure [MEP]
timeFrame: 1 day (a single point in time)
Secondary outcomes:
measure: Brunnstrom stages
timeFrame: 1 day (a single point in time)
measure: Functional Ambulation Scale (FAS)
timeFrame: 1 day (a single point in time)
measure: Daily Living Activity (ADL) Index
timeFrame: 1 day (a single point in time)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul physical medicine rehabilitation training &research hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospita
name: Yunus Emre Dogan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospita
name: Kadriye Ones, Prof
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1183/09031936.97.10122861.
citation: 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.
citation: 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.
citation: 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.