Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Muscle; Pulmonary Function Test
• Intervention / Treatment: Diagnostic test: Spirometry and ultrasonography in stroke group; Diagnostic test: Spirometry and ultrasonography in healthy group

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul physical medicine rehabilitation training &research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stroke patients and, healthy volunteers which have close demographic data with stroke patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragma and Abdominal Muscle Thickness and thickening ratio	Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement	1 day (a single point in time)
Forced vital capacity [FVC]	>%80 is normal results	1 day (a single point in time)
Forced expiratory volume 1 second [FEV1]	>%80 is normal results	1 day (a single point in time)
FEV1/FVC	>%80 is normal results	1 day (a single point in time)
Maximal expiratory flow rate [PEF]	>%80 is normal results	1 day (a single point in time)
Maximum inspiratory pressure [MIP],	>80cmH2O is normal results	1 day (a single point in time)
Maximum expiratory pressure [MEP]	>95cmH2O is normal results	1 day (a single point in time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brunnstrom stages	min 1 max 6, bigger values mean better results,	1 day (a single point in time)
Functional Ambulation Scale (FAS)	min 0 max 5, bigger values mean better results,	1 day (a single point in time)
Daily Living Activity (ADL) Index	min 0 max 100, bigger values mean better results,	1 day (a single point in time)

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Yunus Emre Dogan, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospita; Study Chair: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2020
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 30, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: stroke; ultrasound; pulmonary function; respiratory muscle thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FTRTEZDOGAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No