Clinical trial NCT06286020: Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
Official title: A Randomized Controlled Study to Explore the Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wallenberg Syndrome
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: standardized swallowing assessment
timeFrame: day 1 and day 14
Secondary outcomes:
measure: Murray secretion scale
timeFrame: day 1 and day 14
measure: Rosenbek penetration-aspiration scale
timeFrame: day 1 and day 14
measure: swallowing-quality of life
timeFrame: day 1 and day 14
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Xinzhu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: