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临床试验/NCT06286020
NCT06286020Unknown不适用

A Randomized Controlled Study to Explore the Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

Zeng Changhao1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
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 Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

详细描述

Virtual Reality technology has revolutionized various fields, and its application in rehabilitation medicine is particularly noteworthy. Virtual Reality provides immersive environments that simulate real-life situations, making it an invaluable tool in the rehabilitation process.

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 Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

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

入选标准

  • age ranged from 18-85 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;
  • 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;
  • 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 Virtual Reality Therapy are provided

干预措施: Virtual Reality Therapy (Device)

The experimental group

Experimental

conventional dysphagia treatment and Virtual Reality Therapy are provided

干预措施: Conventional dysphagia treatment (Behavioral)

The control group

Active Comparator

conventional dysphagia treatment is provided

干预措施: Conventional dysphagia treatment (Behavioral)

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.

次要结局

  • Rosenbek penetration-aspiration scale(day 1 and day 14)
  • swallowing-quality of life(day 1 and day 14)
  • Murray secretion scale(day 1 and day 14)

研究者

发起方
Zeng Changhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

研究点 (1)

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