- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606547
Biomechanical Effects of EMST® on Swallowing Function in Parkinson's Disease
May 18, 2026 updated by: University Hospital Muenster
Biomechanical Effects of Expiratory Muscle Strength Training (EMST®) on Swallowing Function in Parkinson's Disease - a Prospective High-resolution Manometry Study
The aim of this non-randomized intervention study is to investigate the detailed effects of a structured four-week EMST® training program on the biomechanics of swallowing function in dysphagic Parkinson's patients.
A combination of fiberoptic endoscopic evaluation of swallowing (FEES) and pharyngeal high-resolution manometry (HRM) will be employed to comprehensively evaluate the neuromuscular changes in swallowing.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sonja Suntrup-Krueger, Prof. Dr. med.
- Phone Number: +49251-83-46811
- Email: sonja.suntrup-krueger@ukmuenster.de
Study Locations
-
-
-
Münster, Germany, 48149
- Recruiting
- University Hospital Münster, Department of Neurology
-
Contact:
- Sonja Suntrup-Krueger, Prof. Dr. med.
- Phone Number: +4925183-46811
- Email: sonja.suntrup-krueger@ukmuenster.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosis of Parkinson's disease,
- PD-related dysphagia as objectively diagnosed with FEES
Exclusion Criteria:
- severe dementia, not able to give consent
- dysphagia related to other diagnoses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMST treatment
daily EMST training on 5 days a week for 1 month
|
5 sets of 5 breaths with EMST per day, 5 days a week for 1 month
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect on swallowing biomechanics in pharyngeal high-resolution manometry as assessed by measurement of e.g. Pharyngeal contractile Integral (PhcI)
Time Frame: 1 month and 3 months
|
metrics of pharyngeal contraction and upper esophageal sphinkter opening in high-resolution pharyngeal manometry
|
1 month and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharyngeal swallowing safety and efficiency as assessed with fiberoptic endoscopic evaluation of swallowing (FEES) applying DIGEST-FEES scoring
Time Frame: 1 month and 3 months
|
Assessment of Swallowing safety and efficiency with DIGEST-FEES,
|
1 month and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sonja Suntrup-Krueger, Prof. Dr. med., University Hospital Münster, Department of Neurology, Albert-Schweitzer-Campus 1, A1, 48149 Münster, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Study Registration Dates
First Submitted
May 6, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Neurodegenerative Diseases
- Esophageal Diseases
- Otorhinolaryngologic Diseases
- Movement Disorders
- Pharyngeal Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Deglutition Disorders
Other Study ID Numbers
- 2025-447-f-S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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