Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

Pulmonary Function Test Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093491
• Other study ID #: FTRTEZDOGAN
• Status: Completed
• Start date: December 25, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: January 2022
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 28, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Function Test
• Respiratory Muscle
• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Istanbul physical medicine rehabilitation training &research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragma and Abdominal Muscle Thickness and thickening ratio	Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement	1 day (a single point in time)
Primary	Forced vital capacity [FVC]	>%80 is normal results	1 day (a single point in time)
Primary	Forced expiratory volume 1 second [FEV1]	>%80 is normal results	1 day (a single point in time)
Primary	FEV1/FVC	>%80 is normal results	1 day (a single point in time)
Primary	Maximal expiratory flow rate [PEF]	>%80 is normal results	1 day (a single point in time)
Primary	Maximum inspiratory pressure [MIP],	>80cmH2O is normal results	1 day (a single point in time)
Primary	Maximum expiratory pressure [MEP]	>95cmH2O is normal results	1 day (a single point in time)
Secondary	Brunnstrom stages	min 1 max 6, bigger values mean better results,	1 day (a single point in time)
Secondary	Functional Ambulation Scale (FAS)	min 0 max 5, bigger values mean better results,	1 day (a single point in time)
Secondary	Daily Living Activity (ADL) Index	min 0 max 100, bigger values mean better results,	1 day (a single point in time)