Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

Not Applicable

Recruiting

• Conditions: Wallenberg Syndrome
• Interventions: Device: Virtual Reality Therapy; Behavioral: Conventional dysphagia treatment

• Registration Number: NCT06286020
• Lead Sponsor: Zeng Changhao

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.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study Start: 2024-02-28
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group	Conventional dysphagia treatment	conventional dysphagia treatment and Virtual Reality Therapy are provided
The experimental group	Virtual Reality Therapy	conventional dysphagia treatment and Virtual Reality Therapy are provided
The control group	Conventional dysphagia treatment	conventional dysphagia treatment is provided

Primary Outcome Measures

Name	Time	Method
standardized swallowing assessment	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.

Secondary Outcome Measures

Name	Time	Method
Rosenbek penetration-aspiration scale	day 1 and day 14	The highest Rosenbek 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).
swallowing-quality of life	day 1 and day 14	Swallowing-quality of life has a score range of 44 - 220, with lower scores indicating poorer swallowing function and poorer quality of life.
Murray secretion scale	day 1 and day 14	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.

Trial Locations

Locations (1)

Xinzhu Rehabilitation Hospital; 🇨🇳 Xinzhu, Taiwan