NCT05194748

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

January 4, 2022

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Camptocormia measurement

    1 hour

Study Arms (2)

camptocormia group

Diaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back

Other: No intervention, observational only

no camptocormia group

Diaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back

Other: No intervention, observational only

Interventions

No intervention, observational only

camptocormia groupno camptocormia group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with Parkinson's Disease in our clinic between June 2021 and January 2023.

You may qualify if:

  • Being diagnosed with Parkinson's
  • Volunteer to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University Faculty of Health Science

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ramazan Kurul, Ph.D

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

December 24, 2021

Primary Completion

January 1, 2023

Study Completion

February 15, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations