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RecruitingNCT06286020Updated Mar 6, 2024

Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome

An interventional study of Virtual Reality Therapy and Conventional dysphagia treatment in Wallenberg Syndrome, sponsored by Zeng Changhao. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Zeng Changhao · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wallenberg Syndrome

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03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Zeng Changhao is the lead sponsor of 59 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    The experimental group

    conventional dysphagia treatment and Virtual Reality Therapy are provided

    Device: Virtual Reality Therapy · Behavioral: Conventional dysphagia treatment

  • Active comparator
    The control group

    conventional dysphagia treatment is provided

    Behavioral: Conventional dysphagia treatment

Interventions

  • DeviceVirtual 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.

  • BehavioralConventional 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.

06

What researchers measure

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.

    Time frame: day 1 and day 14

Secondary outcomes

  1. 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.

    Time frame: day 1 and day 14

  2. Rosenbek penetration-aspiration scale

    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).

    Time frame: day 1 and day 14

  3. 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.

    Time frame: day 1 and day 14

07

Study locations

1 of 1 sites recruiting
  • Xinzhu Rehabilitation Hospital
    Xinzhu, Taiwan
    • Haim Liu · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06286020
Lead sponsor
Zeng Changhao
Responsible party
Zeng Changhao (Research Director, People's Hospital of Zhengzhou University) — Sponsor-investigator
First posted
Feb 29, 2024
Start date
Feb 28, 2024
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Mar 6, 2024

Study contacts

Zhefeng Zeng, Master
Contact
zhengzhouzhj@qq.com
19501376864
Weiji Zhao, Doctor
Contact
zwjww2009@163.com
17839973473
Nieto Luis, Master
study director · Site Coordinator of United Medical Group located in Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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