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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05194748
Other study ID # AIBU-FTR-ETB-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 24, 2021
Est. completion date February 15, 2023

Study information

Verified date April 2024
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Ultrasound can give important information about the morphology of the diaphragm and the amount of contraction. Our aim, with the prediction that a restrictive pathology will occur in the pulmonary function with the addition of camptocormia in Parkinson's patients; to compare respiratory functions in Parkinson's patients with and without camptocormia, to investigate the correlation between ultrasonographically measured diaphragmatic thickness and pulmonary function test values.


Description:

Respiratory complications are one of the most common causes of death in Parkinson's patients. In Parkinson's disease, abnormal flexion of the thoracolumbar spine of 45° or more, which is called camptocormia, increases during walking or standing and disappears completely in the supine position. The prevalence of camptocormia among Parkinson's patients is about 7%. Camptocormia in Parkinson's disease is associated with significant disease disability, higher daily dopaminergic drug dosage, and cognitive impairment. Parkinson's patients with camptocormia often complain of shortness of breath, attributed to reduced pulmonary capacity due to limited chest expansion. Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions. Diaphragmatic thickness indicates diaphragmatic contraction and is correlated with PFT. Our aim; It is a comparison of respiratory functions in Parkinson's patients with and without camptocormia.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date February 15, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Being diagnosed with Parkinson's - Volunteer to participate in the study Exclusion Criteria: - Being in contact with or suffering from COVID-19 - Having diseases that increase intra-abdominal pressure and venous insufficiency - Having diseases that affect diaphragmatic motility - Have had recent thoracic or abdominal surgery - Having a parenchymal, pleural, or chest wall mass that may cause restriction on a recent chest X-ray or CT

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention, observational only
No intervention, observational only

Locations

Country Name City State
Turkey Abant Izzet Baysal University Faculty of Health Science Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary function test When the patient is in the suIt will be evaluated by conventional spirometric measurements. Pulmonary function tests will be applied to all individuals in a sitting position with the "Vmax Encore PFT system, Carefusion, CA USA" brand test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC), expire in the first second of forced expiration (FEV1), and the ratio of FEV1 to FVC (FEV1/FVC) will be recorded.pine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound 1 hour
Primary Ultrasonography When the patient is in the supine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound 1 hour
Secondary Camptocormia measurement Postural deviations of the spine, knees and hips will be recorded through photographs taken from the side and back in the standing position. The individual's flexion of more than 45° from the thoracolumbar spine will be recorded as the presence of camptocormia. Waist, right and left knee circumference measurements also recorded 1 hour
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