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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 12 weeks
Awards & highlights
VRVR Trial 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.
VRVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 0 to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 12 weeks
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
VRVR 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.
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Who is running the clinical trial?
George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,669 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am immunocompromised due to a solid organ transplant.I experience sudden, brief spells of dizziness.I am not on medications that affect my balance or eye movements.I have had a stroke before.My BMI is 40 or higher, indicating severe obesity.I have been diagnosed with heart disease or cardiomyopathy.I am healthy and do not experience dizziness.I have COPD.You have a suspected or confirmed problem with your balance or inner ear.I have chronic kidney disease.I have sickle cell disease.I have a disease affecting my nerves or eye movements.You had a concussion within 7 days before the study enrollment.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Vestibular Rehabilitation Care
- Group 2: Home Exercises Using Virtual Reality Device
- Group 3: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it a requirement that participants in this research be younger than 60 years old?
"To be considered for this trial, applicants must have an age ranging between 18 and 74. For those younger than 18 years old or older than 65, there are 25 other studies available to them."
Answered by AI
How many individuals are actively taking part in this experiment?
"True, according to clinicaltrials.gov this experimental study is actively looking for participants. It was first announced on March 22nd 2021 and the data was most recently updated October 18th 2022. 105 volunteers will be sourced from a single medical facility."
Answered by AI
Is it possible for me to join this clinical research project?
"This medical experiment is looking for 105 individuals with vestibular health issues aged between 18 and 74. To be eligible, candidates must display indications of vestibular dysfunction or serve as a healthy control subject without any symptoms of dizziness."
Answered by AI
Are there any available slots for participants in this experiment?
"Data presented on clinicaltrials.gov implies that this medical study is actively searching for participants, with its inception occurring on March 22nd 2021 and the last edit occuring on October 18th 2022."
Answered by AI
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