NCT05093491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

September 20, 2021

Last Update Submit

January 30, 2022

Conditions

Respiratory MusclePulmonary Function Test

Keywords

strokepulmonary functionultrasoundrespiratory muscle thickness

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Brunnstrom stages

    1 day (a single point in time)

  • Functional Ambulation Scale (FAS)

    1 day (a single point in time)

  • Daily Living Activity (ADL) Index

    1 day (a single point in time)

Study Arms (2)

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

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

Interventions

Spirometry and ultrasonography in stroke groupDIAGNOSTIC_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

Stroke patients
Spirometry and ultrasonography in healthy groupDIAGNOSTIC_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

Healthy individuals

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Ischemic or Hemorrhagic stroke patients
  • Stroke duration \>6 months
  • Mini-mental test score \>24

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul physical medicine rehabilitation training &research hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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. doi: 10.1183/09031936.97.10122861.

    PMID: 9493674BACKGROUND

  • 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.

    PMID: 29643599RESULT

  • 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.

    PMID: 28284044RESULT

  • 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.

    PMID: 26396169RESULT

MeSH Terms

Conditions

Stroke

Interventions

SpirometryUltrasonography

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisDiagnostic Imaging

Study Officials

  • Yunus Emre Dogan, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospita

    PRINCIPAL INVESTIGATOR

  • Kadriye Ones, Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospita

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 26, 2021

Study Start

December 25, 2020

Primary Completion

December 25, 2021

Study Completion

January 28, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)