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Completed

NCT Number: NCT05093491

Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul physical medicine rehabilitation training &research hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometry and ultrasonography in stroke group

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

Spirometry and ultrasonography in healthy group

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

Primary outcomes

  1. Diaphragma and Abdominal Muscle Thickness and thickening ratio

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

    Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement

  2. Forced vital capacity [FVC]

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

    >%80 is normal results

  3. Forced expiratory volume 1 second [FEV1]

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

    >%80 is normal results

  4. FEV1/FVC

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

    >%80 is normal results

  5. Maximal expiratory flow rate [PEF]

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

    >%80 is normal results

  6. Maximum inspiratory pressure [MIP],

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

    >80cmH2O is normal results

  7. Maximum expiratory pressure [MEP]

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

    >95cmH2O is normal results

Secondary outcomes

  1. Brunnstrom stages

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

    min 1 max 6, bigger values mean better results,

  2. Functional Ambulation Scale (FAS)

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

    min 0 max 5, bigger values mean better results,

  3. Daily Living Activity (ADL) Index

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

    min 0 max 100, bigger values mean better results,

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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