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Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

NCT ID: NCT02718963

Last Updated: 2020-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-15

Study Completion Date

2016-06-24

Brief Summary

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The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Detailed Description

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* Design: Prospective study
* Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
* Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
* Setting: Hospital rehabilitation department
* Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Conditions

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Deglutition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

* control group(N=10): who does not have dysphagia symptom
* apply Synchronized Electrical Stimulation Device

* before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function
* during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function

Group Type EXPERIMENTAL

Synchronized Electrical Stimulation Device

Intervention Type DEVICE

electrical stimulation at muscles which related with deglutition

Experimental group

* experimental group(N=10): who have dysphagia symptoms
* apply Synchronized Electrical Stimulation Device

* before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function
* during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function

Group Type EXPERIMENTAL

Synchronized Electrical Stimulation Device

Intervention Type DEVICE

electrical stimulation at muscles which related with deglutition

Interventions

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Synchronized Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Exclusion Criteria

* who reject the checkup their deglutition function by high resolution manometry
* who reject apply "Synchronized Electrical Stimulator"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jusuk Ryu, M.D. PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241.

Reference Type RESULT
PMID: 31180928 (View on PubMed)

Lim J, Hyun SE, Kim H, Ryu JS. Residual effect of sequential 4-channel neuromuscular electrical stimulation evaluated by high-resolution manometry. Biomed Eng Online. 2024 Jul 25;23(1):70. doi: 10.1186/s12938-024-01269-1.

Reference Type DERIVED
PMID: 39049019 (View on PubMed)

Other Identifiers

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B-1507/306-002

Identifier Type: -

Identifier Source: org_study_id