Virtual Reality Training for Vestibular Disorders

(VR-HS-WST Trial)

Overseen By Kwadwo O Appiah-Kubi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clarkson University

Disqualifiers: Concussion, Neuropathic conditions, Musculoskeletal deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new training approach using virtual reality to assist people with vestibular disorders, which can cause dizziness and balance issues. The focus combines head movements and weight shifts to improve balance more effectively than traditional methods. Participants will wear a virtual reality headset while practicing these movements to determine if this method enhances balance and eye reflexes. The trial seeks healthy older adults who can stand without assistance and have not experienced concussions or balance problems in the last six months. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to new treatments for balance disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality training is safe for vestibular disorders?

Research has shown that virtual reality training for balance problems is generally safe, with fewer side effects by the fourth week of use. This treatment uses virtual reality to address balance and dizziness, common issues in individuals with vestibular disorders.

Although specific side effects are not listed, most participants appear to tolerate the treatment well, indicating a generally positive response over time. The virtual reality component provides a modern approach to traditional balance exercises, aiming to improve posture through engaging and enjoyable activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality training for vestibular disorders because it offers a unique approach that combines physical activation with immersive technology. Unlike traditional therapies that might involve basic physical exercises or medication, this method uses virtual reality to engage patients in interactive environments, enhancing their balance and spatial awareness more dynamically. This innovative approach could potentially accelerate recovery and improve postural control by creating a more engaging and effective rehabilitation experience.

What evidence suggests that this virtual reality training is effective for vestibular disorders?

Research has shown that virtual reality for rehabilitation can greatly reduce dizziness and improve balance in people with inner ear balance problems. In this trial, participants will divide into two groups. One group will receive vestibular activation training using virtual reality, involving activities that move the head and improve balance by training the inner ear system. This method aims to enhance the vestibular-ocular reflex (VOR), which helps keep vision steady during head movements, and promote better balance. Studies have indicated that this approach may help the body adjust better to changes in balance and movement. The other group will not receive any training during the trial period. Overall, virtual reality training for balance disorders shows promise for improving balance and reducing symptoms. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals aged 55-80 with vestibular disorders who can stand independently without assistance. Participants will engage in postural assessments and perform headshake activities along with weight shift training.

Inclusion Criteria

I can do balance tests after sudden movements.

I can stand on my own without help.

Participants will also perform headshake activities and weight shift training in standing for 20 mins with mini breaks

Exclusion Criteria

I had orthopedic surgery in the last 6 months affecting my posture.

I have issues with my muscles or bones that affect my posture.

I have had issues with concussion, balance, or eye movements in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo vestibular activation training with headshake activities and postural tasks using virtual reality for 7 days, followed by a 6-day washout period and a 7-day no-training period.

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of balance equilibrium, EMG amplitude, eye movement variability, and VOR gain.

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concurrent Vestibular Activation and Postural Training Using Virtual Reality

Trial Overview The study tests a new rehabilitation method using virtual reality to improve balance and sensory reweighting in people with vestibular dysfunction. It involves concurrent headshake and weight shift training, which may enhance traditional therapy outcomes.

How Is the Trial Designed?

Group I: Vestibular activation training Experimental Treatment 2 Interventions

A cross-over design will be used with group one receiving the training intervention for 7 days, a 6-day washout period, and a 7-day no-training period. Group two will follow the reverse sequence.

Group II: No training Active Control 1 Intervention

Who Is Running the Clinical Trial?

Clarkson University

Lead Sponsor

Trials

4

Recruited

110+

Published Research Related to This Trial

A 4-week virtual reality-based vestibular rehabilitation therapy (VRT) program significantly improved dizziness and balance in 25 patients with peripheral vestibular hypofunction, as shown by a reduction in Dizziness Handicap Inventory scores from 54.60 to 16.84 (p < 0.001).

The therapy also enhanced sensory organization and stability, with significant improvements in the Sensory Organization Test scores and movement parameters, indicating that VR-based VRT can effectively enhance posture stability and quality of life for patients with PVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based vestibular rehabilitation in patients with peripheral vestibular hypofunction. Başoğlu, Y., Şerbetçioğlu, MB., Çelik, İ., et al.[2023]

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.

NCBI (Pubmed)

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. Viziano, A., Micarelli, A., Augimeri, I., et al.[2019]

Virtual reality (VR) interventions significantly improve vestibular rehabilitation outcomes, as shown by better scores on various measures like the Dizziness Handicap Inventory and posturography, based on a meta-analysis of six controlled trials.

VR therapy shows potential clinical benefits over traditional rehabilitation methods for patients with uncompensated peripheral vestibular disorders, but more research is needed to determine the best protocols and any possible side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based programs as vestibular rehabilitative therapy in peripheral vestibular dysfunction: a meta-analysis. Hazzaa, NM., Manzour, AF., Yahia, E., et al.[2023]

A study involving 32 elderly patients with dizziness showed that vestibular rehabilitation exercises supported by virtual reality led to significant improvements in dizziness symptoms and functional mobility compared to conventional rehabilitation methods.

After 6 months, those who underwent virtual reality rehabilitation experienced lasting benefits in emotional well-being, balance, and anxiety levels, indicating that this innovative approach may enhance recovery in older adults with chronic dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of conventional versus virtual reality-based vestibular rehabilitation exercises in elderly patients with dizziness: a randomized controlled study with 6-month follow-up. Kanyılmaz, T., Topuz, O., Ardıç, FN., et al.[2022]

In a study involving 71 patients with unilateral peripheral vestibular loss, both virtual reality-based and conventional balance exercises showed improvements in balance, but there were no significant differences in effectiveness regarding gait speed or other physical outcomes after 6 weeks of rehabilitation.

Participants using virtual reality reported higher enjoyment and less difficulty and tiredness during exercises compared to those using conventional methods, suggesting that while not more effective, virtual reality may enhance the rehabilitation experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of conventional versus virtual reality-based balance exercises in vestibular rehabilitation for unilateral peripheral vestibular loss: results of a randomized controlled trial. Meldrum, D., Herdman, S., Vance, R., et al.[2022]

In a study involving 32 participants (16 with vestibular dysfunction and 16 healthy controls), head movement strategies were effectively assessed using a virtual reality environment, revealing that patients with vestibular issues exhibited different head movement patterns compared to healthy individuals.

The results showed that while patients rotated their heads more sideways and had variable peak frequencies, controls demonstrated higher head acceleration, indicating that head kinematics could be a useful tool for identifying vestibular dysfunction, despite no significant differences in overall postural sway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Oculus Rift Assessment of Dynamic Balance by Head Mobility in a Virtual Park Scene: A Pilot Study. Lubetzky, AV., Hujsak, BD., Fu, G., et al.[2019]

Virtual reality (VR) and augmented reality (AR) significantly reduce symptoms of vestibular dysfunction in patients with unilateral vestibular disease, showing a notable improvement in Dizziness Handicap Inventory (DHI) scores compared to standard rehabilitation methods.

The study reviewed five trials and found that VR and AR interventions led to a standardized mean difference reduction of 1.13 in DHI scores within 0-3 months post-intervention, indicating their efficacy, although the risk of bias in the studies suggests the need for higher quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual and augmented reality in the vestibular rehabilitation of peripheral vestibular disorders: systematic review and meta-analysis. Heffernan, A., Abdelmalek, M., Nunez, DA.[2023]

Virtual reality rehabilitation for peripheral vestibular disorders has shown a significant reduction in symptoms, with an average decrease of 27 points on the Dizziness Handicap Inventory (DHI), improving patients' quality of life from moderate to mild impact.

The effectiveness of virtual reality treatments is linked to the duration of exposure, with at least 150 minutes of cumulative use recommended to achieve positive therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Bergeron, M., Lortie, CL., Guitton, MJ.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05942781/concurrent-vestibular-activation-and-postural-training-using-virtual-reality

Concurrent Vestibular Activation and Postural Training ... The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular- ...

2. trial.medpath.com trial.medpath.com/clinical-trial/a395179f9cdb593a/nct05942781-effects-vestibular-activation-postural-training

Concurrent Vestibular Activation and Postural Training Using ... The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38968181/

Concurrent vestibular activation and postural training ... The aim of the study was to assess sensory reweighting of postural control processing and VOR after concurrent vestibular activation and weight shift training ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11226066/

Concurrent vestibular activation and postural training ... The aim of the study was to assess sensory reweighting of postural control processing and VOR after concurrent vestibular activation and weight shift training ...

5. withpower.com withpower.com/trial/virtual-reality-training-for-vestibular-disorders-121ad

Virtual Reality Training for Vestibular Disorders (VR-HS ... Research shows that virtual reality-based rehabilitation can significantly reduce symptoms of vestibular disorders, such as dizziness, and improve patients' ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0292200

Concurrent vestibular activation and postural training ... Concurrent vestibular activation and WST demonstrated significantly decreased horizontal eye movement and increased automatic postural response ...