Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients

Completed

• Conditions: Pulmonary Function Test; Respiratory Muscle
• Interventions: Diagnostic Test: Spirometry and ultrasonography in healthy group; Diagnostic Test: Spirometry and ultrasonography in stroke group

• Registration Number: NCT05093491
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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 Timeline

• Study Start: 2020-12-25
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Primary Completion: 2021-12-25
• Status Verified: 2022-01
• Study Completion: 2022-01-28
• Last Update Submitted: 2022-01-30
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy individuals	Spirometry and ultrasonography in healthy group	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
Stroke patients	Spirometry and ultrasonography in stroke group	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul physical medicine rehabilitation training &research hospital; 🇹🇷 Istanbul, Turkey