Gaze stabilization Exercises using Virtual Reality Device for Vestibular Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The George Washington University, Department of Health, Human Function and Rehabilitation Science, Washington, United States
Vestibular Diseases+1 More
Gaze stabilization Exercises using Virtual Reality Device - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether virtual reality exercises may help individuals with vestibular disorders.

See full description

Eligible Conditions

  • Vestibular Diseases
  • Vestibular Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Gaze stabilization Exercises using Virtual Reality Device will improve 2 primary outcomes and 3 secondary outcomes in patients with Vestibular Diseases. Measurement will happen over the course of from 0 to 12 weeks.

Week 12
Change in Dizziness Handicap Inventory from baseline to end of treatment
Change in Functional Gait Assessment from baseline to end of treatment
Change in Head Impulse Test 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 Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Healthy Control
1 of 3
Usual Vestibular Rehabilitation Care
1 of 3
Home Exercises Using Virtual Reality Device
1 of 3
Active Control
Experimental Treatment

This trial requires 105 total participants across 3 different treatment groups

This trial involves 3 different treatments. Gaze Stabilization Exercises Using Virtual Reality Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Home Exercises Using Virtual Reality Device
Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
Healthy ControlAge-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.
Usual Vestibular Rehabilitation Care
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 0 to 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from 0 to 12 weeks for reporting.

Who is running the study

Principal Investigator
K. C.
Prof. Keith Cole, Assistant Professor
George Washington University

Closest Location

The George Washington University, Department of Health, Human Function and Rehabilitation Science - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Known or suspected vestibular dysfunction
Healthy volunteers without dizziness to serve as healthy control subjects

Patient Q&A Section

Can vestibular diseases be cured?

"Vestibular disease is not curable, but with conservative and effective management, symptoms can be greatly improved or eliminated. Vestibular Disease (journal) 3(1):13-26, 1993. page(s): 15\n" - Anonymous Online Contributor

Unverified Answer

What is vestibular diseases?

"Vestibular system is a group of structures that is part of the inner ear. An imbalance of the vestibular system, may be responsible for dizziness, nausea, or difficulty balancing. All vestibular disorders has a common origin on the inner ear and it includes both sensorineural and synaptic. The sensorineural disorders is the result of a problem on the inner ear whereas synaptic disorders are the result of a problem in the cerebellum. Vestibular disorders is very common and there are many causes. The vestibular disorders includes imbalance, dizziness, and nystagmus. Vestibular dysfunction are also known by the term Vertigo." - Anonymous Online Contributor

Unverified Answer

What are the signs of vestibular diseases?

"In most vestibular disorders, there is no reliable clinical sign. Some clinical signs may show only in vestibular disease such as a sudden headache or dizziness, and these can be very similar to migraine. However, when the vertigo or the vertigo with a positive Dix-Hallpike test is associated with a negative caloric test, there is a possibility of a vestibular disorder." - Anonymous Online Contributor

Unverified Answer

What are common treatments for vestibular diseases?

"There is high consistency in the type of vestibular disease being treated with the use of a variety of medical professionals and for the use of different treatment options. In a recent study, findings suggest the existence of a core vestibular consensus among otolaryngology residents. The information provided here may help to direct future research and the dissemination of information pertaining to the evaluation and management of vestibular diseases." - Anonymous Online Contributor

Unverified Answer

How many people get vestibular diseases a year in the United States?

"Approximately 1.3 million Americans will develop symptoms due to vestibular disorders within their lifetime. About half of this population will have debilitating or disabling symptoms by the end of their lives. About 1.6 million will be diagnosed with peripheral vestibular syndrome, 4-5 million will manifest central vestibular syndrome, and an estimated 1.7 million will be diagnosed with benign paroxysmal positional vertigo of the inner ear. In addition to the physical symptoms, 1.1 million Americans will die from vestibular diseases in their lifetime owing to the lack of adequate medical and health care." - Anonymous Online Contributor

Unverified Answer

What causes vestibular diseases?

"Men often experience dizziness and balance problems in early life, though such problems can be caused by many underlying factors. These disorders can be traced to a number of underlying causes, and in many cases their aetiology is still not fully understood. vestibular diseases are common in older age groups and can be caused by many different conditions. vestibular diseases are the most common peripheral neuropathy of origin of chronic dizziness symptoms. Such vestibular disorders can be caused by stroke, medication errors, ototoxic medications, medications for other diseases, radiation exposures and environmental toxins and pollutants. vestibular neuropathies are caused by defects in the peripheral vestibular nerve. vestibular disorders can have a large range of clinical symptoms." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in gaze stabilization exercises using virtual reality device for therapeutic use?

"The aim of this study was to describe the use of this device by a group of patients with vestibular diseases. Gaze stabilization exercises can be safely performed according to the protocol previously described and the virtual reality device was useful for the patients with vestibular diseases. More studies need to be carried out to confirm these positive results." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for vestibular diseases?

"Recent findings suggests that [neurologists involved in vestibular rehabilitation with the patient’s or family members' knowledge and consent are important to obtain clinical trials of vestibular rehabilitation (http://www.clinicaltrials.gov)." - Anonymous Online Contributor

Unverified Answer

Is gaze stabilization exercises using virtual reality device safe for people?

"GSE is as safe for people with dizziness/vertigo and other pathologies as normal population; however, caution should be taken for all people due to small sample size. More studies are required to confirm our findings and to determine the potential benefit of these specific exercises in other clinical settings such as those who have chronic neck pain or have sustained head injury. Further studies evaluating the functional outcome of these exercise are required to ascertain the actual long-term impact of these exercises for people diagnosed with vertigo. The study was performed as an off-label drug use trial." - Anonymous Online Contributor

Unverified Answer

Does vestibular diseases run in families?

"vestibulin is important in both inner ear and visual systems and has close associations with the peripheral vestibular system. Based on the above findings, vestibulin could be one of the potential risk genes for progressive familial vestibular dysfunction." - Anonymous Online Contributor

Unverified Answer

Is gaze stabilization exercises using virtual reality device typically used in combination with any other treatments?

"The combination of VR and VE (exposure therapy) seemed to be the strongest treatment approach for both, postural and vestibular symptoms of RBD patients with the best results for the patients with pre-existing dysequilibrium in relation to other treatments (vestibular and visual therapy). This implies that gaze stabilization exercises alone or in combination with other treatment approaches is likely to be used in the future for RBD patients, but with the strongest evidence for combination of VR in combination with gaze stabilization exercises for RBD patients in comparison to other approaches." - Anonymous Online Contributor

Unverified Answer

What is gaze stabilization exercises using virtual reality device?

"In our study we found improvements in VR system performance during exercise sessions. This exercise can be used in rehabilitation clinics or occupational therapies, since it can be performed in a seated position and thus, its application can be carried out without the need for any additional device, which is a practical advantage for these patients. Gaze stabilization exercises can be carried out using a VR system. It could be an economical intervention because the system cost is around €400." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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