Clinical trial NCT06655727: Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound
Official title: Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's Disease and healthy controls

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The EAT-10 (Eating Assessment Tool-10)
timeFrame: 0 day
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 0 day
Secondary outcomes:
measure: Tongue Thickness
timeFrame: 0 day
measure: Distance Between the Hyoid and Mandible
timeFrame: 0 day
measure: Hyoid Displacement Distance:
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References: