Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease

NCT04889170 | Completed

• 1 other identifier: NRZ_EK-20-135-0820
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Dysphagia

Keywords

FEES

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Rosenbek Penetration-Aspiration Scale

  24 Months

• Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the food texture modification categorie

  24 Months

• Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the liquid texture modification categorie

  24 Months

• Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Drooling Severity and Frequency Scale

  24 Months

Study Arms (2)

Biofeedback therapy + Voice training

The intervention has two parts. One part of the intervention is the biofeedback therapy. The biofeedback therapy means that the patient and a speech and language therapist watch the video of the FEES together and discuss the findings. The other part of the intervention is a voice training. The frequency of therapy is minimum 3 times a week, the duration of one therapy is minimum 25 minutes.

Other: Intervention

Biofeedback therapy + Swallow training

The intervention has two parts. One part of the intervention is the biofeedback therapy. The biofeedback therapy means that the patient and a speech and language therapist watch the video of the FEES together and discuss the findings. The other part of the intervention is a swallow training. The frequency of therapy is minimum 3 times a week, the duration of one therapy is minimum 25 minutes.

Other: Intervention

Interventions

Intervention OTHER

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

Biofeedback therapy + Swallow training; Biofeedback therapy + Voice training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurological Rehabilitation Hospital Rosenhügel: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Neurological Rehabilitation Center Rosenhügel

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 17, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)