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Clinical Trials/NCT05093491
NCT05093491CompletedNot Applicable

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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 site in 1 country70 target enrollmentStarted: December 25, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Forced expiratory volume 1 second [FEV1]

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
30 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Forced expiratory volume 1 second [FEV1]

Time Frame: 1 day (a single point in time)

\>%80 is normal results

Diaphragma and Abdominal Muscle Thickness and thickening ratio

Time Frame: 1 day (a single point in time)

Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement

Forced vital capacity [FVC]

Time Frame: 1 day (a single point in time)

\>%80 is normal results

Maximal expiratory flow rate [PEF]

Time Frame: 1 day (a single point in time)

\>%80 is normal results

Maximum inspiratory pressure [MIP],

Time Frame: 1 day (a single point in time)

\>80cmH2O is normal results

FEV1/FVC

Time Frame: 1 day (a single point in time)

\>%80 is normal results

Maximum expiratory pressure [MEP]

Time Frame: 1 day (a single point in time)

\>95cmH2O is normal results

Secondary Outcomes

  • Functional Ambulation Scale (FAS)(1 day (a single point in time))
  • Daily Living Activity (ADL) Index(1 day (a single point in time))
  • Brunnstrom stages(1 day (a single point in time))

Investigators

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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