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临床试验/NCT06224686
NCT06224686已完成不适用

The Effect and Mechanism of Motor Imagery Based on Action Observation Treatment on Dysphagia in Wallenberg Syndrome

Le Wang1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
standardized swallowing assessment

研究概览

简要总结

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

  • the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.
  • apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Participants received conventional dysphagia treatment and motor imagery based on action observation treatment once a day for 14 days. Researchers compared the control group to see the effect and mechanism of motor imagery based on action observation treatment.

详细描述

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

  • the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.
  • apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Both groups received conventional dysphagia treatment, and the experimental group underwent the addition of motor imagery based on action observation treatment to the control group once a day for 14 days. Overall swallowing function was assessed before treatment and after 14 days of intervention. Meanwhile, the functional near infrared spectroscopy was used to detect changes in cerebral hemodynamics during the execution of volitional swallowing task and swallowing motor imagery.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age ranged from 18-80 years and right-handed;
  • •first onset, vital signs stable and conscious;
  • •the dysphagia confirmed by videofluoroscopic swallowing study;
  • •no cognitive impairment, the mini-mental state examination score: >17 for those with an illiterate education, >20 for those with an elementary education, and >24 for those with a secondary education and above;
  • •good motor imagery ability with kinesthetic and visual imagery questionnaire-10 score ≥25;
  • •cranial integrity without craniotomy and/or craniectomy;
  • •patient and/or his/her relative agrees and signs written informed consent.

排除标准

  • •combined ischemic foci at other sites;
  • •presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;
  • •severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;
  • •significant psychological disorders such as anxiety and depression;
  • •infected or broken skin on the head;
  • •poorly controlled epilepsy;
  • •poor patient compliance.

研究组 & 干预措施

The experimental group

Experimental

conventional dysphagia treatment and motor imagery based on action observation treatment

干预措施: conventional dysphagia treatment (Other)

The experimental group

Experimental

conventional dysphagia treatment and motor imagery based on action observation treatment

干预措施: motor imagery based on action observation treatment (Other)

The control group

Active Comparator

conventional dysphagia treatment

干预措施: conventional dysphagia treatment (Other)

结局指标

主要结局

standardized swallowing assessment

时间窗: day 1 and day 14

The standardized swallowing assessment was used to assess the improvement of overall swallowing function, it has a maximum score of 46 and a minimum score of 18, with lower scores indicating better swallowing function.

cortical activation during swallowing motor imagery

时间窗: day 1

The functional near infrared spectroscopy system (Nirsmart, Danyang Huichuang Medical Equipment Co., Ltd., China) was used to detect changes in cerebralhemodynamics during the whole swallowing motor imagery.

cortical activation during volitional swallowing

时间窗: day 1 and day 14

The functional near infrared spectroscopy system (Nirsmart, Danyang Huichuang Medical Equipment Co., Ltd., China) was used to detect changes in cerebralhemodynamics during the execution of volitional swallowing task.

次要结局

  • swallowing-quality of life(day 1 and day 14)
  • yale pharyngeal residue severity rating scale(day 1 and day 14)
  • Rosenbek penetration-aspiration scale(day 1 and day 14)
  • Murray secretion scale(day 1 and day 14)

研究者

发起方
Le Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Le Wang

Master

The First Affiliated Hospital of Zhengzhou University

研究点 (1)

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