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Recruiting NCT07606547

Biomechanical Effects of EMST® on Swallowing Function in Parkinson's Disease

No phase Interventional Parkinson's Disease (PD) Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exspiratory muscle strength training.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD), Dysphagia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Biomechanical Effects of Expiratory Muscle Strength Training (EMST®) on Swallowing Function in Parkinson's Disease - a Prospective High-resolution Manometry Study

Overview

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.

Interventions

  • Device exspiratory muscle strength training
    5 sets of 5 breaths with EMST per day, 5 days a week for 1 month

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital Münster, Department of Neurology — Münster

Identifiers

NCT: NCT07606547 · 2025-447-f-S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗