Biomechanical Effects of EMST® on Swallowing Function in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of Parkinson's disease,
PD-related dysphagia as objectively diagnosed with FEES
Disqualifiers
severe dementia, not able to give consent
dysphagia related to other diagnoses
Trial design
Design model
Single group
Treatments tested in this trial
exspiratory muscle strength training
Device5 sets of 5 breaths with EMST per day, 5 days a week for 1 month
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: EMST treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effect on swallowing biomechanics in pharyngeal high-resolution manometry as assessed by measurement of e.g. Pharyngeal contractile Integral (PhcI)
metrics of pharyngeal contraction and upper esophageal sphinkter opening in high-resolution pharyngeal manometry
Time frame
1 month and 3 monthsSecondary outcomes
1
Pharyngeal swallowing safety and efficiency as assessed with fiberoptic endoscopic evaluation of swallowing (FEES) applying DIGEST-FEES scoring
Assessment of Swallowing safety and efficiency with DIGEST-FEES (Dynamic Imaging Grade of Swallowing Toxicity - FEES), Range 0 (best) - 4 (worst)
Time frame
1 month and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov