Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease

NCT04889170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2023-11-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER
  • Neurological Rehabilitation Hospital Rosenhügel

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889170 on ClinicalTrials.gov