Comprehensive Swallowing Rehabilitation in Patients With MSA

April 22, 2026 updated by: Han Gil Seo, Seoul National University Hospital

Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial

The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple system atrophy (MSA) is a rapidly progressive neurodegenerative disease characterized by parkinsonism, cerebellar syndrome, and autonomic failure. Dysphagia is a clinically significant symptom leading to pneumonia that causes death in patients with MSA. Although the symptoms of dysphagia in the two subtypes of MSA-the parkinsonian variant and the cerebellar variant- are different, there is no significant difference in the latency to onset of tube feeding. Therefore, effective intervention is needed to improve the safety and efficiency of swallowing regardless of the subtypes of MSA.

Although swallowing rehabilitation has been widely applied for swallowing disorders in patients with MSA, few studies have reported the clinical effect of applying swallowing therapy. Comprehensive swallowing rehabilitation has focused on functional muscle training, compensatory swallowing maneuvers, and thermal-tactile stimulation, which is used to treat dysphagia from stroke, Parkinson's disease, and head and neck cancer. Therefore, this study aims to investigate the effect of comprehensive swallowing rehabilitation in patients with MSA.

Study Type

Interventional

Enrollment (Estimated)

24

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

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >19 years
  • Clinically diagnosed with MSA according to the guidelines of the 2nd consensus of the Gilman criteria
  • Clinically diagnosed to have dysphagia by a physiatrist
  • Two or more points on the Penetration-aspiration scale (PAS) from the Videofluoroscopic swallowing study (VFSS) conducted within 3 months

Exclusion Criteria:

  • Moderate to severe cognitive dysfunction with Mini-mental State Examination score < 19
  • Comorbidities or structural abnormalities that may affect swallowing function
  • Other comorbidities that make it difficult to participate in the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive swallowing rehabilitation
Other: Comprehensive swallowing rehabilitation
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
Active Comparator: Swallowing education
Other: Swallowing education
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Penetration-Aspiration Scale
Time Frame: at 6 weeks
at 6 weeks
Videofluoroscopic dysphagia scale
Time Frame: at 6 weeks
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Penetration-Aspiration Scale
Time Frame: at 12 weeks
at 12 weeks
Videofluoroscopic dysphagia scale
Time Frame: at 12 weeks
at 12 weeks
Peak Cough Flow
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Maximal Inspiratory Pressure
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Maximal Expiratory Pressure
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Forced vital capacity
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Forced expiratory volume
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Maximal phonation time
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Swallowing disturbance questionnaire
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks
Swallowing Quality of Life questionnaire
Time Frame: at 6 weeks, at 12 weeks
at 6 weeks, at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Han Gil Seo, MD, PhD, Seoul National University Hospital

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 (Actual)

May 17, 2021

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSA-swrehab-RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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