Clinical trial NCT04889170: Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease
Official title: Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease and Evaluation of the NRZ Dysphagia Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Dysphagia
Keywords: FEES
Lead sponsor: Neurological Rehabilitation Hospital Rosenhügel
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2021-05-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of a Parkinson's disease, who are treated as inpatient in the Neurological Rehabilitation Center Rosenhügel from 12/2020 till 12/2022 and have signed an informed consent form.

Brief summary: Background:

In idiopathic Parkinson's disease, 50% of patients develop in the course of the disease a dysphagia and aspiration pneumonia is the leading cause of death in all parkinsonian syndromes . Dysphagia can negatively impact on the course of Parkinson's disease due to complications such as aspiration pneumonia, malnutrition, inadequate drug action, it causes a deterioration in quality of life and leads to an increase in health care costs of more than 10% Therefore, it is very important to detect subclinical dysphagia in time in Parkinson's disease and to initiate a targeted swallowing therapy. In the Neurological Rehabilitation Center Rosenhügel, patients with Parkinson's disease participate in the Parkinson rehabilitation pathway during their rehabilitation program. A part of the Parkinson rehabilitation pathway is the dysphagia pathway. It includes a clinical swallowing examination, an instrumental assessment of swallowing, performed by a fiberoptic endoscopic evaluation of swallowing (FEES) and a dysphagia training. Because of the serious clinical consequences of dysphagia, the investigators decided to further evaluate the prevalence of subclinical and clinical dysphagia in Parkinson's disease and to assess the efficacy of the NRZ dysphagia pathway. Our goal is to detect and classify all Parkinson's disease patients with dysphagia and to prevent the complications of dysphagia by an early therapeutic intervention.

Objectives Primary objective: Evaluation of prevalence of dysphagia in Parkinson's disease Secondary objective: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia through vocal training or dysphagia training Methods A prospective cohort study will be conducted for 24 months. All patients with the diagnosis of a Parkinson's disease, who are treated as inpatients in the Neurological Rehabilitation Center Rosenhügel from 5/2020 till 5/2022 and have signed an informed consent form will be enrolled in the study. The patients will be examined for dysphagia by a clinical swallowing examination, by a FEES and by measuring the swallowing related quality of life before and after dysphagia training.

Intervention A dysphagia training, which consists of a biofeedback therapy and a swallow training or a voice training. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.

Detailed description: Background:

In idiopathic Parkinson's disease, 50% of patients develop in the course of the disease a dysphagia and aspiration pneumonia is the leading cause of death in all parkinsonian syndromes. Dysphagia in idiopathic Parkinson's disease is subjectively perceived and communicated only in the late stages. Dysphagia can negatively impact on the course of Parkinson's disease due to complications such as aspiration pneumonia, malnutrition, inadequate drug action, it causes a deterioration in quality of life and leads to an increase in health care costs of more than 10% . Therefore, it is very important to detect subclinical dysphagia in time in Parkinson's disease and to initiate a targeted swallowing therapy. Simple screening methods are insufficient for the diagnosis of subclinical swallowing disorders. In the Neurological Rehabilitation Center Rosenhügel, patients with Parkinson's disease participate in the Parkinson rehabilitation pathway during their rehabilitation program. A part of the Parkinson rehabilitation pathway is the dysphagia pathway. It includes a clinical swallowing examination, an instrumental assessment of swallowing, performed by a fiberoptic endoscopic evaluation of swallowing (FEES) and a dysphagia training. Because of the serious clinical consequences of dysphagia, the investigators decided to further evaluate the prevalence of subclinical and clinical dysphagia in Parkinson's disease and to assess the efficacy of the NRZ dysphagia pathway. Our goal is to detect and classify all Parkinson's disease patients with dysphagia and to prevent the complications of dysphagia by an early therapeutic intervention.

Objectives Primary objective: Evaluation of prevalence of dysphagia in Parkinson's disease Secondary objective: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia through vocal training or dysphagia training Methods A prospective cohort study will be conducted for 24 months. All patients with the diagnosis of a Parkinson's disease, who are treated as inpatients in the Neurological Rehabilitation Center Rosenhügel from 5/2020 till 5/2022 and have signed an informed consent form will be enrolled in the study. The patients will be examined for dysphagia by a clinical swallowing examination, by a FEES and by measuring the swallowing related quality of life before and after dysphagia training.

Intervention A dysphagia training, which consists of a biofeedback therapy and a swallow training or a voice training. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.

Results The primary endpoint is the prevalence of clinical and subclinical dysphagia in patients with Parkinsons'disease. Secondary endpoints are the change in the food texture modification categorie as well as the changes in the liquid texture modification categorie, in the Rosenbek Penetration-Aspiration Scale, in the drooling scale an in the swallowing-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a Parkinson's disease
* Inpatient in the Neurological Rehabilitation Center Rosenhügel from 12/2020 till 12/2022
* Informed consent form signed

Exclusion Criteria:

* General contraindications of fiberoptic endoscopic evaluation of swallowing.
* Not feasible fiberoptic endoscopic evaluation of swallowing due to anatomical changes.
* Not feasible fiberoptic endoscopic evaluation of swallowing due to hypersensitivity .
* Not feasible fiberoptic endoscopic evaluation of swallowing due to incompliance.
* Pregnancy.

Primary outcomes:
measure: Prevalence of dysphagia
timeFrame: 24 Months
Secondary outcomes:
measure: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Rosenbek Penetration-Aspiration Scale
timeFrame: 24 Months
measure: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the food texture modification categorie
timeFrame: 24 Months
measure: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the liquid texture modification categorie
timeFrame: 24 Months
measure: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Drooling Severity and Frequency Scale
timeFrame: 24 Months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Neurological Rehabilitation Center Rosenhügel
Study officials:
References: