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临床试验/NCT06321406
NCT06321406已完成不适用

Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing in Post-stroke Dysphagic Patients.

Kayseri City Hospital2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Ultrasonographic measurements

研究概览

简要总结

Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks.

详细描述

A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.

  1. st group; One electrode will be connected to the suprahyoid region and the other electrode will be connected between the thyroid and hyoid cartilages. Superficial neuromuscular stimulation will be applied by the physiotherapist at 80 Hz, 0-25 µA (microampere) current range for 20 minutes, for 5 days for the patient, for a total of 4 weeks. At the same time, each patient will be taught the exercises included in traditional swallowing treatment and will be advised to practice them for 30 minutes every day.
  2. nd group; Exercises such as progressively resistant oral-facial, lingual, laryngeal exercises, tongue strengthening exercises, effortful swallowing maneuver, thermal/tactile stimulation to oropharyngeal muscles, Masako maneuver, Mendelson maneuver, Shaker maneuver, which are included in traditional swallowing treatment, will be taught and practiced for 30 minutes will be recommended for one month.

Patients' dysphagia scales, quality of life survey and ultrasonography measurements will be performed before and after treatment.

Tests to be applied

  • Functional Oral Intake Scale (FOAS)
  • Swallowing Function Screening Test (EAT-10)
  • GUSS (Gagging Swallowing Screening Test)
  • Modified Mann Swallowing Ability Assessment Test (MMASA)
  • SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire),
  • Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

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
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients over 40 years of age with post-stroke dysphagia
  • Patients with Functional Oral Intake Scale (FOAS) 1-6

排除标准

  • Patients younger than 40 years old
  • Dementia, impaired consciousness or hypoesthetic /anesthetic patients
  • Patients with low body mass
  • Patients with pacemakers and severe heart disease
  • Severe hypertension and hypotension
  • Thrombosis or thrombophlebitis
  • Pregnancy

结局指标

主要结局

Ultrasonographic measurements

时间窗: at baseline, 4th week

Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

次要结局

  • SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)(at baseline, 4th week)
  • Functional Oral Intake Scale (FOIS)(at baseline, 4th week)
  • Modified Mann Swallowing Ability Assessment Test (MMASA)(at baseline, 4th week)
  • Swallowing Function Screening Test (EAT-10)(at baseline, 4th week)
  • GUSS (Gagging Swallowing Screening Test)(at baseline, 4th week)

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Havva Talay Çalış

Professor Doctor

Kayseri City Hospital

研究点 (2)

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