Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease and Evaluation of the NRZ Dysphagia Pathway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889170
• Other study ID #: NRZ_EK-20-135-0820
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2023
• Source: Neurological Rehabilitation Hospital Rosenhügel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Parkinson Disease

Intervention

Other:
• Intervention
Intervention: After recording the patient characteristics and the baseline dysphagia characteristics, the intervention begins. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks. The intervention has two parts. One part of the intervention is the biofeedback therapy. The biofeedback therapy means that the patient and an SLT watch the video of the FEES together and discuss the findings. The other part of the intervention is a swallow training or a voice training. The frequency of therapy is minimum 3 times a week, the duration of one therapy is minimum 25 minutes. Allocation to the Groups will be done by a randomization software

Locations

Country	Name	City	State
Austria	Neurological Rehabilitation Center Rosenhügel	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Neurological Rehabilitation Hospital Rosenhügel	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dysphagia	Primary objectives (Hypothesis): Evaluation of prevalence of dysphagia in Parkinson's disease. We assume that 30 percent of the patients will have a clinical dysphagia and 70 percent will have no clinical dysphagia.	24 Months
Secondary	Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Rosenbek Penetration-Aspiration Scale	Description oft he Rosenbek Penetration Aspiration Scale The Rosenbek Penetration Aspiration Scale is an eight point scale, which ranks the two cardinal dysphagia symptoms, penetration and aspiration. The values 2-5 correspond to a penetration and 6-8 to an aspiration. Minimum value: 1 point, maximum value: 8 points; higher scores mean a worse outcome.	24 Months
Secondary	Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the food texture modification categorie	There are 7 categories for food texture modification: Category 1: normal diet (Score: 1 Point) Category 2: Individual phase diet (Score: 2 Points) Category 3: Phase 4 (semi-soft and solid food that can be easily chewed) (Score: 3 Points) Category 4: Phase 3 (softly cooked, easy to mash with the tongue on the palate) (Score: 4 Points) Category 5: Phase 2 (soups/sauces/dessert/breakfast mushy/homogeneous) (Score: 5 Points) Category 6: Phase 1 (all foods mushy/homogenous) (Score: 6 Points) Category 7: Phase 0 (no oral food intake possible) (Score: 7 Points) Minimum value: 1 point, maximum value: 7 points; higher scores mean a worse outcome.	24 Months
Secondary	Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the liquid texture modification categorie	There are 8 categories for liquid texture modification: Category 1: Nonthickened liquid (Score: 1 Point) Category 2: 0.5 MB/200ml thickened liquid (Score: 2 Points) Category 3: 1 MB/200ml thickened liquid (Score: 3 Points) Category 4: 1.5 MB/200ml thickened liquid (Score: 4 Points) Category 5: 2 MB/200ml thickened liquid (Score: 5 Points) Category 6: 2,5 MB/200ml thickened liquid (Score: 6 Points) Category 7: 3 MB/200ml thickened liquid (Score: 7 Points) Category 8: no oral fluid intake possible (Score: 8 Points) Minimum value: 1 point, maximum value: 8 points; higher scores mean a worse outcome.	24 Months
Secondary	Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Drooling Severity and Frequency Scale	Description of the Drooling Severity and Frequency Scale Frequency and spatial extent are recorded. The two individual values together give a total value between 2 (never) and 9. Minimum value: 2 points, maximum value: 9 points; higher scores mean a worse outcome.	24 Months