Clinical trial NCT04782284: Comprehensive Swallowing Rehabilitation in Patients With MSA
Official title: Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy
Dysphagia
Swallowing rehabilitation
Videofluoroscopic Swallowing Study
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: at 6 weeks
measure: Videofluoroscopic dysphagia scale
timeFrame: at 6 weeks
Secondary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: at 12 weeks
measure: Videofluoroscopic dysphagia scale
timeFrame: at 12 weeks
measure: Peak Cough Flow
timeFrame: at 6 weeks, at 12 weeks
measure: Maximal Inspiratory Pressure
timeFrame: at 6 weeks, at 12 weeks
measure: Maximal Expiratory Pressure
timeFrame: at 6 weeks, at 12 weeks
measure: Forced vital capacity
timeFrame: at 6 weeks, at 12 weeks
measure: Forced expiratory volume
timeFrame: at 6 weeks, at 12 weeks
measure: Maximal phonation time
timeFrame: at 6 weeks, at 12 weeks
measure: Swallowing disturbance questionnaire
timeFrame: at 6 weeks, at 12 weeks
measure: Swallowing Quality of Life questionnaire
timeFrame: at 6 weeks, at 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han Gil Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: