Comprehensive Swallowing Rehabilitation in Patients With MSA

Seoul National University

Status: Enrolling

Conditions: Multiple System Atrophy

Treatments: Other: Comprehensive swallowing rehabilitation; Other: Swallowing education

Study type: Interventional

Funder types: Other

Identifiers

NCT04782284

MSA-swrehab-RCT

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Comprehensive swallowing rehabilitation

Experimental group

Treatment:

Other: Comprehensive swallowing rehabilitation

Swallowing education

Active Comparator group

Treatment:

Other: Swallowing education