Wallenberg SyndromeNCT06286020
Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
A study testing Virtual Reality Therapy and Conventional dysphagia treatment in people with Wallenberg Syndrome, run by Zeng Changhao at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wallenberg Syndrome
- What is being tested?
- Virtual Reality Therapy and Conventional dysphagia treatment
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Feb 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Xinzhu Rehabilitation Hospital
Xinzhu
Haim Liu
About this study
Official title: A Randomized Controlled Study to Explore the Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
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.
- Conditions
- Wallenberg Syndrome
- Being tested
- Virtual Reality Therapy, Conventional dysphagia treatment
- Medical subject headings
- Lateral Medullary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional dysphagia treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | conventional dysphagia treatment and Virtual Reality Therapy are provided Receives: Device: Virtual Reality Therapy; Behavioral: Conventional dysphagia treatment |
| The control group | Active comparator | conventional dysphagia treatment is provided Receives: Behavioral: Conventional dysphagia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 14
Secondary outcomes (3)
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.
Measured: day 1 and day 14
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).
Measured: day 1 and day 14
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.
Measured: day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start28 Feb 2024
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wallenberg SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study director, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286020
- Sponsor's protocol ID
- VR-Zhenqiu
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Explore the Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
- ClinicalTrials.gov ID
- NCT06286020
- Acronym / sponsor ID
- VR-Zhenqiu
- Conditions
- Wallenberg Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: Virtual Reality Therapy, Behavioral: Conventional dysphagia treatmentconventional dysphagia treatment and Virtual Reality Therapy are provided |
| The control group | Active comparator | Behavioral: Conventional dysphagia treatmentconventional dysphagia treatment is provided |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TherapyThe 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. | Device | The experimental group |
| Conventional dysphagia treatmentConventional 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. | Behavioural | The control group, The experimental group |
Primary outcome
standardized swallowing assessment
Time frame: 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.
3 secondary outcomes
Murray secretion scale
Time frame: day 1 and day 14
Rosenbek penetration-aspiration scale
Time frame: day 1 and day 14
swallowing-quality of life
Time frame: day 1 and day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study director
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy and Conventional dysphagia treatment in people with Wallenberg Syndrome, run by Zeng Changhao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhefeng Zeng, Master (19501376864, zhengzhouzhj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standardized swallowing assessment (time frame: day 1 and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.