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This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.
The purpose of this study is to investigate the difference in 4ch NMES and 2ch NMES, And to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 channel Electrical Stimulation(revised sequential) | Experimental | apply 4 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it sequentially Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. |
|
| 2 channel Electrical Stimulation(classical) | Active Comparator | apply 2 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it simultaneously suprahyoid m (ch 1), thyrohyoid m (ch 2) with 2 channel electrical stimulation device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 channel Electrical Stimulation Device | Device | electrical stimulation at muscles which related with deglutition |
|
| Measure | Description | Time Frame |
|---|---|---|
| videofluoroscopic dysphagia scale | total score 100 from 0, 100 is worst outcome | baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ju Seok Ryu, M.D. PhD | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Kyungji-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37596323 | Derived | Lim J, Lee JC, Jang EG, Choi SY, Seo KH, Lee SY, Park D, Oh BM, Seo HG, Ryu JS. Kinematic mechanism of the rehabilitative effect of 4-channel NMES: post-hoc analysis of a prospective randomized controlled study. Sci Rep. 2023 Aug 18;13(1):13445. doi: 10.1038/s41598-023-40359-3. | |
| 34059092 | Derived | Seo KH, Jang J, Jang EG, Park Y, Lee SY, Kim BR, Park D, Park S, Hwang H, Kim NH, Oh BM, Seo HG, Lee JC, Ryu JS. Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study. J Neuroeng Rehabil. 2021 May 31;18(1):90. doi: 10.1186/s12984-021-00884-6. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| 2 channel Electrical Stimulation Device | Device | electrical stimulation at muscles which related with deglutition |
|
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |