Comprehensive Swallowing Rehabilitation in Patients With MSA

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

Detailed Description
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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.

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

Conditions
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Multiple System Atrophy

Intervention / Treatment
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* Other: Comprehensive swallowing rehabilitation
* Other: Swallowing education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study