Virtual Reality Vestibular Rehabilitation for Vestibular Disorders

(VRVR Trial)

Overseen by Karen Goodman, DPT

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: George Washington University

Must not be taking: Vestibular medications

Disqualifiers: Stroke, Neurologic disease, Pregnancy, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{2 4 5 6 8}

Research Team

Karen Goodman, DPT

Principal Investigator

The George Washington University

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Gaze stabilization Exercises using Virtual Reality Device (Procedure)
• Gaze stabilization non-instrumented (Behavioral Intervention)

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.

Participant Groups

Group I: Home Exercises Using Virtual Reality Device Experimental Treatment 1 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 Care Active Control 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Jeffrey S. Akman

George Washington University

Chief Executive Officer since 2017

MD from Albert Einstein College of Medicine

Holly Miller

George Washington University

Chief Medical Officer since 2009

MD from Albert Einstein College of Medicine

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances. Meldrum, D., Jahn, K.[2020]

In a study of 69 patients with chronic unilateral vestibular hypofunction, vestibular rehabilitation therapy combined with Wii® therapy significantly reduced dizziness handicap, as shown by a decrease in the Dizziness Handicap Inventory score from a median of 40 to 24 (P<.0001).

The therapy also improved balance and visual stability, with the Dynamic Gait Index score increasing from a median of 21 to 23 and dynamic visual acuity improving from a median of 2 to 1, both with statistical significance (P<.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. Verdecchia, DH., Mendoza, M., Sanguineti, F., et al.[2022]

In patients with unilateral vestibular pathology, the angular vestibular ocular reflex (aVOR) gain does not differ when the head is rotated inward or outward, suggesting that both directions can be used for effective assessment.

The study indicates that head velocity is inversely correlated with aVOR gain for movements towards the affected side, which can inform physical therapists in prescribing gaze stability exercises for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute VOR gain differences for outward vs. inward head impulses. Schubert, MC., Mantokoudis, G., Xie, L., et al.[2015]

Vestibular rehabilitation therapy (VRT) is an effective exercise-based treatment that helps improve balance, reduce vertigo, and enhance daily activities for individuals with vestibular disorders, regardless of age or the cause of their symptoms.

Key exercises in VRT focus on head-eye movements and balance tasks, and even short, frequent sessions can significantly aid in vestibular recovery by promoting adaptation and substitution mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. Han, BI., Song, HS., Kim, JS.[2022]

A study of 159 patients with vestibular deficits showed that modified VOR X1 exercises focusing on high-velocity head movements significantly improved dizziness and balance, achieving 93-99% of normal scores across multiple outcome measures.

This new speed-based approach, combined with balance training for postural realignment, outperformed traditional vestibular rehabilitation techniques, suggesting it could be a more effective method for treating peripheral vestibular hypofunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A speed-based approach to vestibular rehabilitation for peripheral vestibular hypofunction: A retrospective chart review. Roller, RA., Hall, CD.[2022]

Dynamic visual acuity (DVA) testing in virtual reality (VR) showed similar results to traditional clinical methods, indicating that VR can be a valid platform for vestibular assessments.

The study found that head motion conditions affected DVA scores, balance, and dizziness ratings, with no motion trials yielding the best results, suggesting that VR testing can effectively replicate traditional assessments in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging virtual reality for vestibular testing: Clinical outcomes from tests of dynamic visual acuity. Holford, KC., Jagodinsky, AE., Saripalle, R., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Spain pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Acute VOR gain differences for outward vs. inward head impulses. [2015]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A speed-based approach to vestibular rehabilitation for peripheral vestibular hypofunction: A retrospective chart review. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Leveraging virtual reality for vestibular testing: Clinical outcomes from tests of dynamic visual acuity. [2022]