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Virtual Reality Vestibular Rehabilitation for Vestibular Disorders (VRVR Trial)

N/A
Recruiting
Led By Karen Goodman, DPT
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
immunocompromised state from a solid organ transplant
Current symptoms of benign paroxysmal positional hypofunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 12 weeks
Awards & highlights

Summary

This trial is testing whether virtual reality exercises can help improve symptoms for people with vestibular disorders, compared to standard exercises and healthy controls.

Who is the study for?
This trial is for people with dizziness due to vestibular disorders and healthy volunteers without dizziness. It's not for those with severe obesity, recent concussion, chronic kidney disease, heart issues, stroke history, or on certain medications affecting balance/eye movements.Check my eligibility
What is being tested?
The study tests how well virtual reality (VR) exercises improve symptoms compared to standard exercises in individuals with vestibular disorders. Participants will use a VR device that controls visual input during exercise to find the right type and dose of therapy.See study design
What are the potential side effects?
Potential side effects may include temporary increased dizziness or nausea from the VR exercises. Since this involves physical activity, there might also be a risk of fatigue or discomfort associated with exercise.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am immunocompromised due to a solid organ transplant.
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I experience sudden, brief spells of dizziness.
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I have had a stroke before.
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My BMI is 40 or higher, indicating severe obesity.
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I have been diagnosed with heart disease or cardiomyopathy.
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I have COPD.
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I have chronic kidney disease.
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I have sickle cell disease.
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I have a disease affecting my nerves or eye movements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Dizziness Handicap Inventory from baseline to end of treatment
Change in Head Impulse Test from baseline to end of treatment
Secondary outcome measures
Change in Functional Gait Assessment from baseline to end of treatment
Change in Visual Vertigo Analogue Scale from baseline to end of treatment
Change in modified Clinical Test of Sensory Integration and Balance (mCTSIB) from baseline to end of treatment

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Home Exercises Using Virtual Reality DeviceExperimental Treatment1 Intervention
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
Group II: Usual Vestibular Rehabilitation CareActive Control1 Intervention
Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.
Group III: Healthy ControlActive Control1 Intervention
Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Virtual reality (VR) vestibular exercises work by providing controlled visual stimuli and precise measurement of exercise performance, which are crucial for patients with vestibular disorders. The controlled visual environment helps to reduce the discomfort caused by moving objects and distracting backgrounds, making it easier for patients to perform exercises. By simulating various visual and spatial scenarios, VR can help retrain the brain to better process sensory information, thereby improving balance and reducing dizziness. Additionally, the ability to measure exercise performance accurately allows for tailored therapy that can be adjusted based on the patient's progress, ensuring more effective and personalized treatment.

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,147 Total Patients Enrolled
Karen Goodman, DPTPrincipal InvestigatorThe George Washington University
Keith Cole, DPT, PhDPrincipal Investigator - The George Washington University
Scottsdale Healthcare Shea
Medical School - University of Arizona, Tucson, Doctor of Medicine
Stanford University, Residency in Otolaryngology

Media Library

Gaze stabilization Exercises using Virtual Reality Device Clinical Trial Eligibility Overview. Trial Name: NCT04851184 — N/A
Vestibular Disorder Research Study Groups: Usual Vestibular Rehabilitation Care, Home Exercises Using Virtual Reality Device, Healthy Control
Vestibular Disorder Clinical Trial 2023: Gaze stabilization Exercises using Virtual Reality Device Highlights & Side Effects. Trial Name: NCT04851184 — N/A
Gaze stabilization Exercises using Virtual Reality Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851184 — N/A
~19 spots leftby May 2025