Parkinson DiseaseNCT04889170
Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease
An observational study of Parkinson Disease and Dysphagia, run by Neurological Rehabilitation Hospital Rosenhügel at 1 site in Austria.
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 . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease, Dysphagia
- What is being tested?
- Intervention
- How many people
- 180 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of a Parkinson's disease
- Inpatient in the Neurological Rehabilitation Center Rosenhügel from 12/2020 till 12/2022
- Informed consent form signed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease and Evaluation of the NRZ Dysphagia Pathway
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease, Dysphagia
- Being tested
- Intervention
- Keywords
- FEES
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 24 Months
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.
Measured: 24 Months
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.
Measured: 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
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurological Rehabilitation Hospital Rosenhügel
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889170
- Sponsor's protocol ID
- NRZ_EK-20-135-0820
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease and Evaluation of the NRZ Dysphagia Pathway
- ClinicalTrials.gov ID
- NCT04889170
- Acronym / sponsor ID
- NRZ_EK-20-135-0820
- Conditions
- Parkinson Disease, Dysphagia
- Keywords
- FEES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Neurological Rehabilitation Hospital RosenhügelUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback therapy + Voice training | – | Other: InterventionThe 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. |
| Biofeedback therapy + Swallow training | – | Other: InterventionThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of a Parkinson's disease
- Inpatient in the Neurological Rehabilitation Center Rosenhügel from 12/2020 till 12/2022
- Informed consent form signed
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIntervention: 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 | Other | Biofeedback therapy + Swallow training, Biofeedback therapy + Voice training |
Primary outcome
Prevalence of dysphagia
Time frame: 24 Months
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.
4 secondary outcomes
Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Rosenbek Penetration-Aspiration Scale
Time frame: 24 Months
Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the food texture modification categorie
Time frame: 24 Months
Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the liquid texture modification categorie
Time frame: 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
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dysphagia, run by Neurological Rehabilitation Hospital Rosenhügel at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dysphagia (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.