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Comprehensive Swallowing Rehabilitation in Patients With MSA

Primary Purpose

Multiple System Atrophy

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Comprehensive swallowing rehabilitation

Swallowing education

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive swallowing rehabilitation

Swallowing education

Arm Description

Outcomes

Primary Outcome Measures

Penetration-Aspiration Scale

Videofluoroscopic dysphagia scale

Secondary Outcome Measures

Penetration-Aspiration Scale

Videofluoroscopic dysphagia scale

Peak Cough Flow

Maximal Inspiratory Pressure

Maximal Expiratory Pressure

Forced vital capacity

Forced expiratory volume

Maximal phonation time

Swallowing disturbance questionnaire

Swallowing Quality of Life questionnaire

Full Information

NCT ID

NCT04782284

First Posted

March 1, 2021

Last Updated

October 24, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04782284

Brief Title

Comprehensive Swallowing Rehabilitation in Patients With MSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple System Atrophy

Keywords

Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Comprehensive swallowing rehabilitation

Arm Type

Experimental

Arm Title

Swallowing education

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Comprehensive swallowing rehabilitation

Intervention Description

The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.

Intervention Type

Other

Intervention Name(s)

Swallowing education

Intervention Description

The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.

Primary Outcome Measure Information:

Title

Penetration-Aspiration Scale

Time Frame

at 6 weeks

Title

Videofluoroscopic dysphagia scale

Time Frame

at 6 weeks

Secondary Outcome Measure Information:

Title

Penetration-Aspiration Scale

Time Frame

at 12 weeks

Title

Videofluoroscopic dysphagia scale

Time Frame

at 12 weeks

Title

Peak Cough Flow

Time Frame

at 6 weeks, at 12 weeks

Title

Maximal Inspiratory Pressure

Time Frame

at 6 weeks, at 12 weeks

Title

Maximal Expiratory Pressure

Time Frame

at 6 weeks, at 12 weeks

Title

Forced vital capacity

Time Frame

at 6 weeks, at 12 weeks

Title

Forced expiratory volume

Time Frame

at 6 weeks, at 12 weeks

Title

Maximal phonation time

Time Frame

at 6 weeks, at 12 weeks

Title

Swallowing disturbance questionnaire

Time Frame

at 6 weeks, at 12 weeks

Title

Swallowing Quality of Life questionnaire

Time Frame

at 6 weeks, at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Han Gil Seo, MD, PhD

Phone

82-2-2072-1659

hgseo80@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Han Gil Seo, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Han Gil Seo, MD, PhD

Phone

82-2-2072-1659

hgseo80@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comprehensive Swallowing Rehabilitation in Patients With MSA

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