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Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

30. januar 2022 opdateret af: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Diagnostisk 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
Diagnostisk 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Brunnstrom stages
Tidsramme: 1 day (a single point in time)
min 1 max 6, bigger values mean better results,
1 day (a single point in time)
Functional Ambulation Scale (FAS)
Tidsramme: 1 day (a single point in time)
min 0 max 5, bigger values mean better results,
1 day (a single point in time)
Daily Living Activity (ADL) Index
Tidsramme: 1 day (a single point in time)
min 0 max 100, bigger values mean better results,
1 day (a single point in time)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Efterforskere

  • Ledende efterforsker: Yunus Emre Dogan, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
  • Studiestol: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. december 2020

Primær færdiggørelse (Faktiske)

25. december 2021

Studieafslutning (Faktiske)

28. januar 2022

Datoer for studieregistrering

Først indsendt

20. september 2021

Først indsendt, der opfyldte QC-kriterier

13. oktober 2021

Først opslået (Faktiske)

26. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FTRTEZDOGAN

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