Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

NCT ID: NCT06286020

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Wallenberg Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The experimental group

conventional dysphagia treatment and Virtual Reality Therapy are provided

Group Type: EXPERIMENTAL

Virtual Reality Therapy

Intervention Type: DEVICE

The therapist begins by assessing the patient's swallowing abilities and creating a personalized treatment plan. This involves determining the appropriate Virtual Reality Therapy scenarios, difficulty levels, and specific swallowing goals tailored to the patient's condition.

Conventional dysphagia treatment

Intervention Type: BEHAVIORAL

Conventional dysphagia treatment included oropharyngeal muscle movement training, orofacial alternating hot and cold stimulation, Masako swallowing training, Mendelsohn maneuver, therapeutic ingestion training, intermittent oral-esophageal tube feeding, etc., 30 min each time, once a day for 14 consecutive days.

The control group

conventional dysphagia treatment is provided

Group Type: ACTIVE_COMPARATOR

Conventional dysphagia treatment

Intervention Type: BEHAVIORAL

Conventional dysphagia treatment included oropharyngeal muscle movement training, orofacial alternating hot and cold stimulation, Masako swallowing training, Mendelsohn maneuver, therapeutic ingestion training, intermittent oral-esophageal tube feeding, etc., 30 min each time, once a day for 14 consecutive days.

Interventions

Virtual Reality Therapy

The therapist begins by assessing the patient's swallowing abilities and creating a personalized treatment plan. This involves determining the appropriate Virtual Reality Therapy scenarios, difficulty levels, and specific swallowing goals tailored to the patient's condition.

Intervention Type: DEVICE

Conventional dysphagia treatment

Conventional dysphagia treatment included oropharyngeal muscle movement training, orofacial alternating hot and cold stimulation, Masako swallowing training, Mendelsohn maneuver, therapeutic ingestion training, intermittent oral-esophageal tube feeding, etc., 30 min each time, once a day for 14 consecutive days.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeng Changhao

OTHER

Sponsor Role: lead

Responsible Party

Zeng Changhao

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_DIRECTOR

Site Coordinator of United Medical Group located in Miami

Locations

Xinzhu Rehabilitation Hospital

Xinzhu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Zhefeng Zeng, Master

Role: CONTACT

zhengzhouzhj@qq.com

19501376864

Weiji Zhao, Doctor

Role: CONTACT

zwjww2009@163.com

17839973473

Facility Contacts

Haim Liu

Role: primary

Other Identifiers

VR-Zhenqiu

Identifier Type: -

Identifier Source: org_study_id