Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

NCT ID: NCT05093491

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-25

Study Completion Date

2022-01-28

Brief Summary

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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

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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.

Conditions

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Respiratory Muscle Pulmonary Function Test

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Spirometry and ultrasonography in stroke group

Intervention Type DIAGNOSTIC_TEST

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

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

Spirometry and ultrasonography in healthy group

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Spirometry and ultrasonography in stroke group

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

Intervention Type DIAGNOSTIC_TEST

Spirometry and ultrasonography in healthy group

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunus Emre Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Kadriye Ones, Prof

Role: STUDY_CHAIR

Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Locations

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Istanbul physical medicine rehabilitation training &research hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 9493674 (View on PubMed)

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.

Reference Type RESULT
PMID: 29643599 (View on PubMed)

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.

Reference Type RESULT
PMID: 28284044 (View on PubMed)

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.

Reference Type RESULT
PMID: 26396169 (View on PubMed)

Other Identifiers

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FTRTEZDOGAN

Identifier Type: -

Identifier Source: org_study_id

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