Comprehensive Swallowing Rehabilitation in Patients With MSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive swallowing rehabilitation, Swallowing education.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
Overview
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.
Interventions
- Other Comprehensive swallowing rehabilitation
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks. - Other Swallowing education
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.
Primary outcome measures
- Penetration-Aspiration Scale [Time frame: at 6 weeks]
- Videofluoroscopic dysphagia scale [Time frame: at 6 weeks]
Secondary outcome measures (10)
- Penetration-Aspiration Scale [Time frame: at 12 weeks]
- Videofluoroscopic dysphagia scale [Time frame: at 12 weeks]
- Peak Cough Flow [Time frame: at 6 weeks, at 12 weeks]
- Maximal Inspiratory Pressure [Time frame: at 6 weeks, at 12 weeks]
- Maximal Expiratory Pressure [Time frame: at 6 weeks, at 12 weeks]
- Forced vital capacity [Time frame: at 6 weeks, at 12 weeks]
- Forced expiratory volume [Time frame: at 6 weeks, at 12 weeks]
- Maximal phonation time [Time frame: at 6 weeks, at 12 weeks]
- Swallowing disturbance questionnaire [Time frame: at 6 weeks, at 12 weeks]
- Swallowing Quality of Life questionnaire [Time frame: at 6 weeks, at 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT04782284 · MSA-swrehab-RCT