105 Participants Needed

Virtual Reality Vestibular Rehabilitation for Vestibular Disorders

(VRVR Trial)

KC
KG
KC
Overseen ByKeith Cole, DPT,PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: George Washington University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a VR headset to help people with dizziness from vestibular disorders do specific exercises. The VR device shows visual scenes to make the exercises more comfortable and effective. The study aims to find the right amount of exercise needed to improve symptoms. Virtual reality-based therapy has been recently studied and shown to improve symptoms in patients with vestibular disorders.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that affect the vestibular (balance-related) or oculomotor (eye movement-related) system, so you may need to stop taking such medications to participate.

Is Virtual Reality Vestibular Rehabilitation safe for humans?

Virtual Reality Vestibular Rehabilitation, which includes gaze stabilization exercises, is generally considered safe for humans. Studies have shown it can help improve symptoms like dizziness and vertigo without significant safety concerns.12345

How is the virtual reality vestibular rehabilitation treatment different from other treatments for vestibular disorders?

This treatment is unique because it uses virtual reality technology to enhance gaze stabilization exercises, providing an immersive and interactive environment that may improve patient engagement and outcomes compared to traditional vestibular rehabilitation methods.13567

What data supports the effectiveness of the treatment Virtual Reality Vestibular Rehabilitation for Vestibular Disorders?

Research shows that gaze stabilization exercises, a key part of vestibular rehabilitation, help improve balance and reduce dizziness in people with vestibular disorders. Studies also indicate that using virtual reality in these exercises can enhance their effectiveness, as seen in patients with vertigo who reported improved symptoms and satisfaction with virtual reality-based therapy.12568

Who Is on the Research Team?

KG

Karen Goodman, DPT

Principal Investigator

The George Washington University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am healthy and do not experience dizziness.
You have a suspected or confirmed problem with your balance or inner ear.

Exclusion Criteria

I am immunocompromised due to a solid organ transplant.
I experience sudden, brief spells of dizziness.
Currently pregnant, or plan to become pregnant during the timeline of the study
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants with Unilateral Vestibular Hypofunction (UVH) undergo a 4-week intervention, while those with Bilateral Vestibular Hypofunction (BVH) or post-concussion undergo a 12-week intervention. The intervention includes physical therapy visits and a home program of vestibular exercises using a virtual reality device.

4-12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including vestibulo-ocular assessment, balance, and clinical functional outcome measures.

4 weeks
2 visits (in-person)

Healthy Control Assessment

Healthy control subjects are tested for one day to compare outcomes with those of participants with vestibular disorders.

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Gaze stabilization Exercises using Virtual Reality Device
  • Gaze stabilization non-instrumented
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

Published Research Related to This Trial

Gaze stabilisation exercises are effective in improving the vestibular ocular reflex (VOR) gain, which helps patients with vestibular hypofunction maintain visual clarity during head movements and reduce dizziness and vertigo symptoms.
Recent studies incorporating digital technologies have shown promise in enhancing gaze stabilisation exercises, suggesting potential advancements in vestibular rehabilitation practices.
Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances.Meldrum, D., Jahn, K.[2020]
In a study of 20 patients with unilateral vestibular hypofunction, virtual reality (VR) vestibular rehabilitation was evaluated and compared to conventional therapy, showing promising results in improving symptoms of vertigo.
Both VR and conventional therapy groups reported significant improvements in their symptoms, indicating that VR may be an effective alternative for vestibular rehabilitation, although specific statistical outcomes were not detailed.
Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction.Stankiewicz, T., Gujski, M., Niedzielski, A., et al.[2021]
Adding virtual reality-based home exercises to conventional vestibular rehabilitation significantly improved vestibulo-ocular reflex gain and posturography scores in patients with unilateral vestibular hypofunction, with the mixed-method group showing a gain score of 0.71 compared to 0.64 in the conventional group after one year.
Patients who engaged in virtual reality exercises reported greater improvements in their dizziness-related quality of life, as indicated by a Dizziness Handicap Inventory score of 24.34 versus 35.73 in the conventional group, highlighting the efficacy of this approach in long-term rehabilitation.
Long-term effects of vestibular rehabilitation and head-mounted gaming task procedure in unilateral vestibular hypofunction: a 12-month follow-up of a randomized controlled trial.Viziano, A., Micarelli, A., Augimeri, I., et al.[2019]

Citations

Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances. [2020]
Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. [2021]
Long-term effects of vestibular rehabilitation and head-mounted gaming task procedure in unilateral vestibular hypofunction: a 12-month follow-up of a randomized controlled trial. [2019]
Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]
Acute VOR gain differences for outward vs. inward head impulses. [2015]
Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. [2022]
A speed-based approach to vestibular rehabilitation for peripheral vestibular hypofunction: A retrospective chart review. [2022]
Leveraging virtual reality for vestibular testing: Clinical outcomes from tests of dynamic visual acuity. [2022]
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