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Comprehensive Swallowing Rehabilitation in Patients With MSA

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ClinicalTrials.gov Identifier: NCT04782284
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Han Gil Seo, 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.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Other: Comprehensive swallowing rehabilitation Other: Swallowing education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Comprehensive swallowing rehabilitation Other: Comprehensive swallowing rehabilitation
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.

Active Comparator: Swallowing education Other: Swallowing education
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.




Primary Outcome Measures :
  1. Penetration-Aspiration Scale [ Time Frame: at 6 weeks ]
  2. Videofluoroscopic dysphagia scale [ Time Frame: at 6 weeks ]

Secondary Outcome Measures :
  1. Penetration-Aspiration Scale [ Time Frame: at 12 weeks ]
  2. Videofluoroscopic dysphagia scale [ Time Frame: at 12 weeks ]
  3. Peak Cough Flow [ Time Frame: at 6 weeks, at 12 weeks ]
  4. Maximal Inspiratory Pressure [ Time Frame: at 6 weeks, at 12 weeks ]
  5. Maximal Expiratory Pressure [ Time Frame: at 6 weeks, at 12 weeks ]
  6. Forced vital capacity [ Time Frame: at 6 weeks, at 12 weeks ]
  7. Forced expiratory volume [ Time Frame: at 6 weeks, at 12 weeks ]
  8. Maximal phonation time [ Time Frame: at 6 weeks, at 12 weeks ]
  9. Swallowing disturbance questionnaire [ Time Frame: at 6 weeks, at 12 weeks ]
  10. Swallowing Quality of Life questionnaire [ Time Frame: at 6 weeks, at 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782284


Contacts
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Contact: Han Gil Seo, MD, PhD 82-2-2072-1659 hgseo80@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Han Gil Seo, MD, PhD    82-2-2072-1659    hgseo80@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Han Gil Seo, MD, PhD Seoul National University Hospital
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Responsible Party: Han Gil Seo, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04782284    
Other Study ID Numbers: MSA-swrehab-RCT
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Gil Seo, Seoul National University Hospital:
Multiple System Atrophy
Dysphagia
Swallowing rehabilitation
Videofluoroscopic Swallowing Study
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases