Improving swallowing function in patients with Parkinson's disease using a specialized training device
Evaluation of the Efficacy of a Two-week Expiratory Muscle Training on Swallowing Function in Patients With Parkinsonian Disorders
This study is testing if a special breathing exercise program can help people with Parkinson's disease and similar conditions swallow better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kliniken Beelitz GmbH Academic / other |
| Locations | 3 sites (Beelitz-Heilstätten, Brandenburg and 2 other locations) |
| Trial ID | NCT05139342 on ClinicalTrials.gov |
What this trial studies
This interventional therapy evaluates the effectiveness of a two-week expiratory muscle strength training (EMST) program on swallowing function in patients with neurodegenerative disorders such as Parkinson's disease, Multiple System Atrophy, and Progressive Supranuclear Palsy. Participants will undergo a fiberendoscopic evaluation of swallowing before and after the intervention to assess changes in dysphagia. The training is conducted independently by patients following guidance from a speech and language pathologist, and data will be collected through questionnaires to measure swallowing disturbances and quality of life. The main hypothesis is that EMST will significantly improve dysphagia scores in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with idiopathic Parkinson's disease, Multiple System Atrophy, or Progressive Supranuclear Palsy.
Not a fit: Patients with severe pulmonary disease, severe dementia, or other competing causes of dysphagia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance swallowing function and improve the quality of life for patients with Parkinsonian disorders.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving swallowing function in patients with dysphagia, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age with. * diagnosis of idiopathic Parkinson's disease according to the updated diagnostic criteria (Postuma 2015) or (3) Diagnosis of a possible or probable Multiple System Atrophy according to the diagnostic criteria (Gilman 2008) or (4) Diagnosis of a possible or probable progressive supranuclear gaze palsy according to the diagnostic criteria (Höglinger 2017) (5) in Hoehn and Yahr stages I-V. Exclusion Criteria: 1. Patients that do not sign the informed consent form 2. Patients who have contraindications for a fiberendoscopic swallowing examination 3. Patients who have contraindications to the two weeks of EMST training (e.g., severe pulmonary disease, severe dementia). 4. Patients who have competing causes of dysphagia (e.g., history of stroke, tumor in the neck).
Where this trial is running
Beelitz-Heilstätten, Brandenburg and 2 other locations
- Movement Disorders Hospital - Kliniken Beelitz — Beelitz-Heilstätten, Brandenburg, Germany (Recruiting)
- Universitätsklinium Münster — Münster, Germany (Not_yet_recruiting)
- Klinikum Osnabrück — Osnabrück, Germany (Recruiting)
Study contacts
- Principal investigator: Florin Gandor, MD — Movement Disorders Hospital Beelitz-Heilstätten,
- Study coordinator: Florin Gandor, MD
- Email: gandor@kliniken-beelitz.de
- Phone: +493320422781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.