Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound

NCT06655727 | Completed

• 1 other identifier: BeylikduzuStateH5
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• The EAT-10 (Eating Assessment Tool-10)

  The EAT-10 (Eating Assessment Tool-10) is a validated self-administered questionnaire designed to assess symptoms of dysphagia (difficulty swallowing). It consists of 10 questions that evaluate the severity of swallowing difficulties, including issues related to eating, drinking, and managing saliva. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (severe problem). A total score of 3 or higher suggests the presence of clinically significant dysphagia, and it helps guide further diagnostic evaluation and management.

  0 day

• Unified Parkinson's Disease Rating Scale (UPDRS)

  The UPDRS is a comprehensive tool used to evaluate the severity and progression of Parkinson's disease. It consists of multiple sections assessing motor and non-motor symptoms, helping clinicians understand the impact of the disease on daily functioning. The UPDRS is widely used in both clinical practice and research to monitor disease progression and treatment effects. In the MDS-UPDRS, higher scores indicate more severe Parkinson's disease symptoms. Each item is rated from 0 (normal) to 4 (severe), with the total score reflecting the overall disease severity. A higher total score means worse motor and non-motor symptoms, indicating greater impairment and reduced quality of life. Lower scores suggest milder symptoms and better functional status.

  0 day

Secondary Outcomes (3)

• Tongue Thickness

  0 day

• Distance Between the Hyoid and Mandible

  0 day

• Hyoid Displacement Distance:

  0 day

Study Arms (2)

Parkinson disease group

Patients with Parkinson's disease

Diagnostic Test: Ultrasound evaluation

Control group

Healthy volunteers

Diagnostic Test: Ultrasound evaluation

Interventions

Ultrasound evaluation DIAGNOSTIC_TEST

No intervention

Control group; Parkinson disease group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parkinson's Disease and healthy controls

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease by a neurologist.
• Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
• Scoring at least 24 on the Mini-Mental State Examination (MMSE).
• Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.

You may not qualify if:

• Presence of head or neck cancer that could cause dysphagia.
• History of radiotherapy or surgery in the head and neck region.
• Diagnosis of vascular parkinsonism or stroke.
• Presence of cardiopulmonary disease that could affect swallowing or breathing.
• Having received voice or swallowing therapy in the last 6 months.
• Presence of a diagnosed psychiatric disorder.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 25, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)