Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease
Condition: Parkinson Disease; Dysphagia
MeSH terms: Deglutition Disorders; Parkinson Disease
Study type: Observational

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.
    

Intervention name(s): Intervention
Intervention type(s): Other
Intervention description(s): 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
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.
      
Keywords: FEES