Comprehensive Swallowing Rehabilitation in Patients With MSA

Not Applicable

Recruiting

• Conditions: Multiple System Atrophy
• Interventions: Other: Comprehensive swallowing rehabilitation; Other: Swallowing education

• Registration Number: NCT04782284
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-05-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive swallowing rehabilitation	Comprehensive swallowing rehabilitation	-
Swallowing education	Swallowing education	-

Primary Outcome Measures

Name	Time	Method
Penetration-Aspiration Scale	at 6 weeks
Videofluoroscopic dysphagia scale	at 6 weeks

Secondary Outcome Measures

Name	Time	Method
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
Swallowing disturbance questionnaire	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 Quality of Life questionnaire	at 6 weeks, at 12 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of