Multiple System Atrophy
Conditions
Keywords
Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study
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.
Interventions
OTHERComprehensive swallowing rehabilitation
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
OTHERSwallowing education
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Penetration-Aspiration Scale | at 6 weeks |
| Videofluoroscopic dysphagia scale | at 6 weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
CONTACTHan Gil Seo, MD, PhD
PRINCIPAL_INVESTIGATORHan Gil Seo, MD, PhD
Seoul National University Hospital
Outcome results
None listed