Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

NCT06328569 | Not Yet Recruiting

• 1 other identifier: VR Wallenberg Syndrome
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wallenberg Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Murray secretion scale

  day 1 and day 14

• penetration-aspiration scale

  day 1 and day 14

• swallowing-quality of life

  day 1 and day 14

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

conventional dysphagia treatment and Virtual Reality Therapy are provided

Device: Virtual Reality Therapy; Behavioral: Conventional dysphagia treatment

conventional dysphagia treatment group

ACTIVE COMPARATOR

conventional dysphagia treatment is provided

Behavioral: Conventional dysphagia treatment

Interventions

Virtual Reality Therapy 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.

Virtual Reality group

Conventional dysphagia treatment 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.

Virtual Reality group; conventional dysphagia treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Lateral Medullary Syndrome

Condition Hierarchy (Ancestors)

Brain Stem Infarctions; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nieto Luis

  Site Coordinator of United Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianyun Lu

CONTACT

15333866454; zengxizdyfy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03