Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome: A Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wallenberg Syndrome
• Intervention / Treatment: Device: Virtual Reality Therapy; Behavioral: Conventional dysphagia treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qianyun Lu; Phone Number: 15333866454; Email: zengxizdyfy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age more than 18, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality group; conventional dysphagia treatment and Virtual Reality Therapy are provided	Device: 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.; Behavioral: 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.
Active Comparator: conventional dysphagia treatment group; conventional dysphagia treatment is provided	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
standardized swallowing assessment	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.	day 1 and day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
swallowing-quality of life	Swallowing-quality of life has a score range of 44 - 220, with lower scores indicating poorer swallowing function and poorer quality of life.	day 1 and day 14
Murray secretion scale	The severity of Murray secretion scale was measured using a grade of 0-3, patients without obvious saliva accumulation are scored as Murray secretion scale grade 0, whereas patients who had secretions in the laryngeal vestibule at the start of the exam were assigned grade 3.	day 1 and day 14
penetration-aspiration scale	The highest penetration-aspiration scale score is 8 and the lowest is 1 (1 = no entry of material into the airway; 2 - 5 = penetration of material past the mouse into the supraglottic space and traveling as far as the true vocal folds; 6 - 8 = tracheal aspiration of material below the true vocal folds).	day 1 and day 14

Collaborators and Investigators

• Sponsor: Copka Sonpashan
• Investigators: Principal Investigator: Nieto Luis, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 9, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Brain Ischemia; Infarction; Stroke; Brain Infarction; Brain Stem Infarctions; Syndrome; Lateral Medullary Syndrome
• Other Study ID Numbers: VR Wallenberg Syndrome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No