Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
Dysphagia
About this trial
This is an interventional treatment trial for Dysphagia
Eligibility Criteria
Inclusion Criteria:
- Patients with oropharyngeal dysphagia confirmed by video fluoroscopy
- Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia
- Patients aged between 19 and under 90 years of age regardless of gender
- Those who voluntarily consent to the clinical trial and can visit for the next observation
- Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.)
Exclusion Criteria:
- In case of refusal of inspection
- Who do not agree
- When instructions cannot be performed due to mental illness, etc.
- Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck
- Pregnant and lactating women
- Pre-interview is conducted only with women of childbearing age to determine whether they are pregnant or lactating. If pregnancy is confirmed during the pre-interview, it is excluded from the test.
- Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions
- Others who have comorbidities (e.g., malignant tumors, severe renal/liver/lung diseases, blood clotting abnormalities, etc.) that are inappropriate for participation in clinical trials as judged by the researcher
- Persons with pacemakers and other internal electrical stimulators
- Those who are participating in other clinical trials at the time of screening
- Those who are judged by other researchers to be inappropriate for this clinical trial
Sites / Locations
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
classical electrical stimulation protocol (control group)
revised sequential activation protocol (experimental group)
Apply 2-channel electrical stimulation device with protocol 1. It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.
Apply 4-channel electrical stimulation device with protocol 2. It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.