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临床试验/NCT06184711
NCT06184711尚未招募不适用

Efficiency of McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation in Individuals With Post-Stroke Dysphagia

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Penetration Aspiration Scale

研究概览

简要总结

This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.

详细描述

Stroke is a neurological disorder that causes focal or global cerebral dysfunction caused by vascular causes, can last for 24 hours or longer, or may result in death. Many complications occur after stroke, and one of the most common complications is dysphagia After dysphagia, individuals with dehydration, malnutrition, aspiration, aspiration-related pneumonia, sepsis, and even death may result if no precautions are taken. Purpose of dysphagia treatment; It is to ensure that individuals receive their daily water and calorie needs most reliably. Another goal is to switch the patient to oral nutrition as much as possible. McNeill Dysphagia Therapy Programme is a systematic exercise-based therapy program developed for individuals with dysphagia. It is also frequently used in the rehabilitation of stroke, traumatic brain injury, and post-cancer dysphagia. Transcranial Magnetic Stimulation (TMS) is based on the principle of electromagnetic induction. It is a non-invasive method that, together with the magnetic field created by a coil placed on the scalp, causes electrical stimulation in the cerebral cortex and creates neurophysiological arrangements in different parts of the brain. Without the electrode, electrical energy is transferred to the human brain and the cerebral cortex is stimulated. An action potential is created by stimulation in neuronal membranes and causes neurons to fire. Thus, nerve cells are stimulated and the process of reorganization of the brain begins. With the stimulation of the cerebral cortex, the swallowing centre is stimulated and the muscles associated with swallowing are activated. The efficacy of MDTP combined with r TMS, MDTP combined with sham r TMS and r TMS alone will be compared in the intervention of dysphagia after stroke. Patients in all three groups will be subjected to both clinical assessment tools and instrumental evaluation before and after treatment. Data will be evaluated using the Mann Swallowing Ability Assessment Test, Penetration Aspiration Scale, Functional Oral Intake Scale, Visual Analogue Scale, Dynamic Rating Scale of Swallowing Toxicity, Dysphagia Severity Rating Scale

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative

排除标准

  • Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain

结局指标

主要结局

Penetration Aspiration Scale

时间窗: Change from baseline from 3 weeks

Penetration Aspiration Scale (PAS): An 8-point severity rating. Scale 1 = no substance enters the airways 8 = substance enters the airways, passes under the vocal cords without any effort to expel it.

Functional Oral Intake Scale

时间窗: Change from baseline from 3 weeks

FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)

Dynamic Rating Scale of Swallowing Toxicity

时间窗: Change from baseline from 3 weeks

Dynamic Imaging Grading of Ingestion Toxicity (DIGEST): residue less than 10% of the bolus = 0 point, residue less than half of the bolus = 1 point, residue less than 90% of the bolus = 2 points, residue more than 90% of the bolus = 3 points, residue in all consistencies tested = 4 points.

Dysphagia Severity Scale

时间窗: Change from baseline from 3 weeks

Dysphagia Severity Scale (DSS); those ranked from "level 1" to "level 4'' are categorized into the "choking/aspiration group (severe group)". In DSS, those ranked from "level 5" to "level 7'' are categorized into the "without choking/aspiration group (mild group)".

次要结局

  • Mann Swallowing Ability Assessment Test(Change from baseline from 3 weeks)
  • Visual Analogue Scale (VAS)(Change from baseline from 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Nur Şimşek

Speech and Language Therapist

Ankara City Hospital Bilkent

研究点 (2)

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