NCT06286020

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 22, 2024

Last Update Submit

March 2, 2024

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

  • Rosenbek penetration-aspiration scale

    day 1 and day 14

  • swallowing-quality of life

    day 1 and day 14

Study Arms (2)

The experimental group

EXPERIMENTAL

conventional dysphagia treatment and Virtual Reality Therapy are provided

Device: Virtual Reality TherapyBehavioral: Conventional dysphagia treatment

The control group

ACTIVE COMPARATOR

conventional dysphagia treatment is provided

Behavioral: Conventional dysphagia treatment

Interventions

Virtual Reality TherapyDEVICE

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.

The experimental group
Conventional dysphagia treatmentBEHAVIORAL

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.

The control groupThe experimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinzhu Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

MeSH Terms

Conditions

Lateral Medullary Syndrome

Condition Hierarchy (Ancestors)

Brain Stem InfarctionsBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Nieto Luis, Master

    Site Coordinator of United Medical Group located in Miami

    STUDY DIRECTOR

Central Study Contacts

Zhefeng Zeng, Master

CONTACT

19501376864zhengzhouzhj@qq.com

Weiji Zhao, Doctor

CONTACT

17839973473zwjww2009@163.com

Study Design

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

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

February 28, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)