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

Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: Ultrasound evaluation

Detailed Description

Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Beylikdüzü State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Parkinson's Disease and healthy controls

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Healthy volunteers	Diagnostic test: Ultrasound evaluation; No intervention
Parkinson disease group; Patients with Parkinson's disease	Diagnostic test: Ultrasound evaluation; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue Thickness	Tongue thickness refers to the measurement of the width or thickness of the tongue in centimeters. This parameter is evaluated using ultrasound to assess the muscle mass and structural integrity of the tongue, which plays a critical role in swallowing function. In conditions like dysphagia, reduced tongue thickness may indicate weakened tongue muscles, contributing to swallowing difficulties.	0 day
Distance Between the Hyoid and Mandible	This is the measurement of the space between the hyoid bone and the mandible (lower jaw) while the individual is at rest or during swallowing. It is typically measured in centimeters and can provide insights into the positioning and movement of structures involved in swallowing. An abnormal distance between these structures may indicate dysfunction in the swallowing mechanism.	0 day
Hyoid Displacement Distance:	The hyoid bone plays a key role in the swallowing process by facilitating the elevation and forward movement of the larynx. Insufficient hyoid displacement can lead to impaired swallowing function, as it affects the coordination of muscles involved in the swallow. The measurement of this displacement helps assess the efficiency and safety of the swallowing mechanism.	0 day

Collaborators and Investigators

• Sponsor: Beylikduzu State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: BeylikduzuStateH5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No