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Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients

NCT05139342 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-06-15

No results posted yet for this study

Summary

This is an interventional therapy study designed to evaluate the efficacy of a two-week intervention, i.e. training with a specialized exhalation training device (called expiratory muscle strength training; EMST150 or EMST75; Aspire Products, Gainsville, FL) on swallowing function in patients with neurodegenerative Parkinsonian disorders. This study involves a routine endoscopic evaluation of swallowing (FEES) to diagnose dysphagia before and after the intervention. Between the two FEES, a two-week exhalation training program takes place, which the patients perform independently following instructions from a speech and lanuage pathologist. In addition demographic and disease-specific data and two questionnaires (Swallowing Disturbance Questionnaire for Parkinson's disease patients, SDQ-PD, and Swallowing specific Quality Of Life Questionnaire SWAL-QoL) are recorded.

Conditions

Interventions

DEVICE

expiratory muscle strentgh training (EMST)

All patients undergo EMST training, and results will be compared between groups. After individual adjustment of the EMST device for each patient, the patient receives speeach adn instruction from a speech and language pathologist on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days.

Sponsors & Collaborators

  • Kliniken Beelitz GmbH

    lead OTHER

Principal Investigators

  • Florin Gandor, MD · Movement Disorders Hospital Beelitz-Heilstätten,

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05139342 on ClinicalTrials.gov