NCT05483582Unknown不适用
Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Comparison of VDS total change
研究概览
简要总结
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 effect by the electric stimulation method 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.
详细描述
- Design: Prospective study
- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
- Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Penetration aspiration scale (PAS), Measured by kinematic metaphysical analysis. The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D Anderson dysphagia inventory was used to measure the diet-related quality of life. The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
- Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, measuring the effect on Tongue Strength through IOPI, the effect on changes in body composition through Bioelectrical Impedance Analysis (BIA; InBody S10, InBody, Inc.), and whether there is a significant change in actual patient intake and nutritional status through oral intake survey and MNA-SF measure. An exploratory comparison of intervention effects over time between 2-week and 4-week interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.)
排除标准
- •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
研究组 & 干预措施
classical electrical stimulation protocol (control group)
Active Comparator
- 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.
干预措施: 2-channel Electrical Stimulation Device (Device)
revised sequential activation protocol (experimental group)
Experimental
- 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.
干预措施: 4-channel Electrical Stimulation Device (Device)
结局指标
主要结局
Comparison of VDS total change
时间窗: 300 to 600 minutes
Comparison of VDS total change between the two groups using the results of the video fluoroscopic swallowing test between the experimental group and the control group
次要结局
- Satisfaction evaluation of treatment device(10 to 30 minutes)
- Results of pre- and post-intervention surveys(30 to 60 minutes)
- Using the results of the video fluoroscopic swallowing test(300 to 600 minutes)
- Exploratory observation of the effect of electrical stimulation therapy(30 to 60 minutes)
研究者
Ju Seok Ryu
Professor
Seoul National University Hospital
研究点 (1)
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