Vestibular DisorderVRVRNCT04851184
Dose of Vestibular Rehabilitation for Vestibular Hypofunction
A study testing Gaze stabilization Exercises using Virtual Reality Device and Gaze stabilization non-instrumented in people with Vestibular Disorder, run by George Washington University at 1 site in United States.
Trial summary
The purposes of this research are to 1) utilize virtual reality (VR) to evaluate the exercise dose required to improve symptoms in those with vestibular (dizziness) disorders, 2) compare VR vestibular exercises to standard exercises, and 3) compare exercise performance outcomes to healthy controls without vestibular… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Gaze stabilization Exercises using Virtual Reality Device and Gaze stabilization non-instrumented
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known or suspected vestibular dysfunction
- Healthy volunteers without dizziness to serve as healthy control subjects
Who cannot join
- Previous cerebrovacular accident (stroke)
- Reported neurologic or oculuomotor disease
- Taking of medications that affect the vestibular or oculomotor system.
- Current symptoms of benign paroxysmal positional hypofunction
- Concussion occuring less than 7 days prior to enrollment in this study
- Currently pregnant, or plan to become pregnant during the timeline of the study
Show all 12Show fewer
- Chronic kidney disease
- COPD
- Known coronary artery disease or cardiomyopathy
- immunocompromised state from a solid organ transplant
- Severe Obesity as defined by BMI of greater than or equal to 40 kg/m2
- Sickle cell disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University, Department of Health, Human Function and Rehabilitation Science
Washington D.C., District of Columbia, 20006
About this study
Official title: Dose of Vestibular Rehabilitation Required for Clinical Improvements in Individuals With Vestibular Hypofunction.
The purposes of this research are to 1) utilize virtual reality (VR) to evaluate the exercise dose required to improve symptoms in those with vestibular (dizziness) disorders, 2) compare VR vestibular exercises to standard exercises, and 3) compare exercise performance outcomes to healthy controls without vestibular disorders. Even though more than 35% of those over 40, and ~50% of those who have had concussion have such symptoms, the dose of specific exercises targeted to improve symptoms is not well defined. In this study, the investigators will use a wireless VR device to measure key parameters and response to exercise. Another advantage of the VR device is the ability to control what the individual can see while performing the exercise. In normal daily life, moving objects and distracting backgrounds can make vestibular exercise too uncomfortable to perform. Using these methods, the investigators aim to determine the appropriate type and amount of exercise required for symptom improvement. This study will also compare the effectiveness of performing exercises in the virtual reality environment to standard physical therapy and to healthy persons without history of vestibular disorders. Three categories of vestibular disorders will be investigated with an instrumented and usual therapy group of 1) Unilateral hypofunction, 2) bilateral hypofunction, and 3) post-concussion.
Read the detailed description
Disorders of vestibular function are prevalent disorders that result in dizziness, decreased balance, and a 12-fold increased risk of falls.1 It has been determined that 20% of community-dwelling adults over the age of 60 report vestibular symptoms prompting a medical evaluation or intervention over a one year period.2 This equates to approximately $50.0 billion in annual healthcare costs.3 In the US alone, there are approximately 1.6-3.8 million sport concussions each year,4,5 where 50% of concussed athletes have at least one vestibular type symptom.6 Although the impact of cost has been demonstrated in older adults, the costs of concussion-related dizziness is much more difficult to calculate due simultaneously treating symptoms from multiple systems.
A common treatment for symptoms related to disorders of vestibular function is vestibular rehabilitation, a sub-specialty of physical therapy. These exercises are performed daily by Subjects at home and consist of visually fixating on a target while moving the head and/or the object on which the subject is fixating. To alter exercise difficulty, exercise parameters are altered including: visual background complexity (plain and dark, busy but stationary, moving objects, rapidly moving objects), postural positioning (seated, standing with a wide base of support, standing with a narrow base of support, standing on one leg), and duration of exercise (from 5 seconds to approximately 2 minutes). Early evidence shows that vestibular rehabilitation exercises provided by a physical therapist is an effective method of ameliorating vestibular hypofunction. Further, effectiveness of vestibular rehabilitation does not decline with increasing age of the patient,8 indicating benefit for all ages that are affected. Unfortunately, many factors limit the ability to determine efficiency and efficacy of treatment and have been highlighted in a recent clinical practice guideline9 and systematic review5,10. Limitations include: poor measurement of prescribed exercise compliance by depending on subjective report, inability to control for environmental factors during home program execution, and the influence of noxious vestibular input associated with traveling to attend scheduled physical therapy visits. These factors hinder performing high quality efficacy studies, resulting in exercise prescription being largely based on expert opinion, the lowest level on the hierarchy of evidence-based practice.11 In fact, current opinion indicates that exercises should be performed 3 times a day for a total of 12 minutes with each bout lasting approximately 2 minutes, all with no clear indication of speed and amplitude of performance. In this study, the investigators aim to use a commercially available virtual reality device to deliver usual vestibular rehabilitation exercises, while using the device's inbuilt sensors to accurately measure head movement, speed and duration. Using this device, the investigators will assess compliance and dose of exercises required to reduce symptoms of dizziness and imbalance and to determine if performing such exercises in a virtual reality environment will provide similar results to that usual rehabilitation techniques.
When a potential subject is identified, the subject will be screened for appropriateness of inclusion for this study. After informed consent has been obtained from a recruited subject, those with Unilateral Vestibular Hypofunction (UVH) will be asked to perform a 4-week intervention, while those with Bilateral Vestibular Hypofunction (BVH) or those post-concussion will each be asked to perform a 12-week intervention. Those with UVH will undergo a shorter intervention due to strong evidence that neural adaptation occurs much more quickly (usually 4 weeks) than those with BVH and history of concussion.9,10,17-19 The intervention will consist of physical therapy visits combined with a home program of specific vestibular exercises. Each subject will be asked to attend physical therapy visits at least one time per week throughout the 4- or 12-week period.
Assessments will be performed on all groups and consist of a combination of vestibulo-ocular assessment, balance and clinical functional outcome measures, and surveys of subject satisfaction. Subjects are randomly assigned to the usual rehabilitation or intervention group based on each of the following diagnostic categories.
The compliance to exercises will be obtained from a log in the virtual reality device for the VR group, and will be paper based for the usual physical therapy group. Subjects in the three intervention groups will be asked to perform the same type of exercises as the usual rehabilitation group, but using a virtual reality device that will be issued to the patient for home use. Subjects will use a custom designed program to perform the exercises using a commercially available virtual reality device (no specialized hardware or additions to the commercially available device will be performed). Subjects will be instructed on the first day in how to operate the Virtual Reality Vestibular Rehabilitation (VRVR) program and how to properly perform the exercises. The VRVR device and software will simulate a virtual reality 'room' with an 'X' fixed in front of a wall. There are six different background complexities. Exercise sessions will start seated upright in a chair and will progress to standing per the home exercise protocol. The system will prompt the patient to begin the exercise and will automatically log the frequency and duration of exercise performed. The system will ask the patient to rate the severity of their symptoms on a 0-10 scale before and after each bout of exercise. Subjects' instruction regarding initial dose and progression will be identical to those given in the usual rehabilitation group. Subjects will be asked to bring their device with them to their 4 week, 8 week, and 12 weeks appointment to transfer their de-identified data and to insure integrity of the data and device. Subjects will be asked to return the device at the end of the intervention period.
Per patient and therapist discretion, additional physical therapy visits may be scheduled to aid in patient understanding of exercise progression protocol, assess correct performance of exercise (with or without virtual reality device). Non-study related physical therapy visits may be scheduled between sessions in order to address impairments unrelated to vestibulo-ocular deficits. These may include interventions to address musculoskeletal deficits or other balance related impairments. Any additional sessions of physical therapy will be reported in order to determine possible confounding information.
There will be an additional group of healthy control subjects that will be tested for only one day. Healthy subjects will be recruited through flyers, approved email lists, and word of mouth in the general public. This healthy control group will perform the same tests as the other groups perform on Day 1. This group will be used to compare outcomes of usual rehabilitation and intervention groups, to the function of those without disorders of vestibular function.
- Conditions
- Vestibular Disorder
- Being tested
- Gaze stabilization Exercises using Virtual Reality Device, Gaze stabilization non-instrumented
- Keywords
- gaze stability, vestibular hypofunction
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze stabilization Exercises using Virtual Reality DeviceDevice
Participants will utilize a wireless virtual reality headset to perform their gaze stabilization exercises to better control the background and visual field as well as collect data related to speed, excursion, and duration of head movements.
Gaze stabilization non-instrumentedBehavioural
Participants will perform gaze stabilization exercises in a non-instrumented manner. Subjects are instructed to focus on a letter on a piece of paper held at arm's length. They are instructed to move their head back and forth as quickly as they can while keeping the letter in focus. The total duration of the exercise (from 10 - 240 seconds) and background complexity (simple to complex moving) are increased gradually according to patient symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Usual Vestibular Rehabilitation Care | Active comparator | 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. Receives: Behavioral: Gaze stabilization non-instrumented |
| Home Exercises Using Virtual Reality Device | Experimental | Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP. Receives: Device: Gaze stabilization Exercises using Virtual Reality Device |
| Healthy Control | No 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. The healthy-control group will only be assessed at baseline (a single visit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
Final score on the Dizziness Handicap Inventory. The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire used to measure a patient's self-perceived impact of dizziness on their daily life, divided into physical, emotional, and functional subscales. In this study, only the total score (sum of subscales) was used. To score the DHI, each of the 25 questions is answered with "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points), resulting in a total score from 0 to 100. A higher score indicates a greater perceived handicap, a lower score indicates less perceived handicap. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Measured: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Head Impulse Test at Final Assessment
Assessment of VOR-evoked gaze stability. The head impulse test (HIT) assesses the vestibulo-ocular reflex (VOR) to detect peripheral vestibular dysfunction, or a weakened balance system in the inner ear. In the test, the examiner quickly rotates a patient's head while the patient tries to keep their eyes fixed on a target. A normal response involves the eyes staying fixed on the target, but an abnormal test shows the eyes moving away with the head and then quickly "catching up" with a corrective saccade, indicating the VOR isn't keeping up. Count of participants enrolled in the study are those with a positive clinical finding. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Measured: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Secondary outcomes (3)
Visual Vertigo Analogue Scale Final Assessment
Final assessment. The Visual Vertigo Analogue Scale (VVAS) is a 9-item self-administered questionnaire that assesses the intensity of visual vertigo in various challenging visual situations. Patients mark a 10-cm line for each of the nine items to indicate dizziness severity (0 indicates no dizziness and 10 as extreme). Scores are averaged and then multiplied by 10 for a scale from 0 to 100, where a lower score indicates a milder symptom level, and higher score indicates more severe symptoms of visual vertigo. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Measured: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Functional Gait Assessment Final Assessment
The Functional Gait Assessment (FGA) is a 10-item clinical test used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Each of the 10 items is scored on a 0-3 scale (0=severe impairment, 3=normal), with the total score ranging from 0 to 30 indicating balance and gait ability. A higher FGA score signifies better performance, and a lower score indicates poorer performance. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Measured: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) Final Performance
The Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is a four-condition balance assessment that evaluates how well individuals use their visual, somatosensory, and vestibular systems to maintain balance. The scoring involves timing up to three trials of each of the four conditions for 30 seconds, and then summing the average of trials within each condition. The total score ranges from 0 to 120, where a lower score indicates poorer performance and a higher score indicates better performance. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Measured: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start22 Mar 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: Recruitment challenges for in-person visits of the affected population and a change in employment of the study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Cole, George Washington University
- Investigators
- Karen Goodman, DPT, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851184
- Sponsor's protocol ID
- NCR180548
- Acronym
- VRVR
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2021
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
PubMed 19468085Sloane PD, Coeytaux RR, Beck RS, Dallara J. Dizziness: state of the science. Ann Intern Med. 2001 May 1;134(9 Pt 2):823-32. doi: 10.7326/0003-4819-134-9_part_2-200105011-00005.
PubMed 11346317Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.
PubMed 29512120Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
PubMed 27655831Kontos AP, Elbin RJ, Schatz P, Covassin T, Henry L, Pardini J, Collins MW. A revised factor structure for the post-concussion symptom scale: baseline and postconcussion factors. Am J Sports Med. 2012 Oct;40(10):2375-84. doi: 10.1177/0363546512455400. Epub 2012 Aug 16.
PubMed 22904209Alghadir AH, Iqbal ZA, Whitney SL. An update on vestibular physical therapy. J Chin Med Assoc. 2013 Jan;76(1):1-8. doi: 10.1016/j.jcma.2012.09.003. Epub 2012 Dec 26.
PubMed 23331774Whitney SL, Wrisley DM, Marchetti GF, Furman JM. The effect of age on vestibular rehabilitation outcomes. Laryngoscope. 2002 Oct;112(10):1785-90. doi: 10.1097/00005537-200210000-00015.
PubMed 12368616Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
PubMed 26913496McDonnell MN, Hillier SL. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Cochrane Database Syst Rev. 2015 Jan 13;1(1):CD005397. doi: 10.1002/14651858.CD005397.pub4.
PubMed 25581507Mantzoukas S. A review of evidence-based practice, nursing research and reflection: levelling the hierarchy. J Clin Nurs. 2008 Jan;17(2):214-23. doi: 10.1111/j.1365-2702.2006.01912.x. Epub 2007 Apr 5.
PubMed 17419779Cohen HS, Kimball KT. Increased independence and decreased vertigo after vestibular rehabilitation. Otolaryngol Head Neck Surg. 2003 Jan;128(1):60-70. doi: 10.1067/mhn.2003.23.
PubMed 12574761Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. Epub 2015 Apr 30.
PubMed 26556560Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.
PubMed 28723718Rosiak O, Krajewski K, Woszczak M, Jozefowicz-Korczynska M. Evaluation of the effectiveness of a Virtual Reality-based exercise program for Unilateral Peripheral Vestibular Deficit. J Vestib Res. 2018;28(5-6):409-415. doi: 10.3233/VES-180647.
PubMed 30714985Alahmari KA, Sparto PJ, Marchetti GF, Redfern MS, Furman JM, Whitney SL. Comparison of virtual reality based therapy with customized vestibular physical therapy for the treatment of vestibular disorders. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):389-99. doi: 10.1109/TNSRE.2013.2294904.
PubMed 24608691
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose of Vestibular Rehabilitation Required for Clinical Improvements in Individuals With Vestibular Hypofunction.
- ClinicalTrials.gov ID
- NCT04851184
- Acronym / sponsor ID
- VRVR / NCR180548
- Conditions
- Vestibular Disorder
- Keywords
- gaze stability, vestibular hypofunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges for in-person visits of the affected population and a change in employment of the study team
- Enrolment
- 28 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this research are to 1) utilize virtual reality (VR) to evaluate the exercise dose required to improve symptoms in those with vestibular (dizziness) disorders, 2) compare VR vestibular exercises to standard exercises, and 3) compare exercise performance outcomes to healthy controls without vestibular disorders. Even though more than 35% of those over 40, and ~50% of those who have had concussion have such symptoms, the dose of specific exercises targeted to improve symptoms is not well defined. In this study, the investigators will use a wireless VR device to measure key parameters and response to exercise. Another advantage of the VR device is the ability to control what the individual can see while performing the exercise. In normal daily life, moving objects and distracting backgrounds can make vestibular exercise too uncomfortable to perform. Using these methods, the investigators aim to determine the appropriate type and amount of exercise required for symptom improvement. This study will also compare the effectiveness of performing exercises in the virtual reality environment to standard physical therapy and to healthy persons without history of vestibular disorders. Three categories of vestibular disorders will be investigated with an instrumented and usual therapy group of 1) Unilateral hypofunction, 2) bilateral hypofunction, and 3) post-concussion.
Detailed description
Disorders of vestibular function are prevalent disorders that result in dizziness, decreased balance, and a 12-fold increased risk of falls.1 It has been determined that 20% of community-dwelling adults over the age of 60 report vestibular symptoms prompting a medical evaluation or intervention over a one year period.2 This equates to approximately $50.0 billion in annual healthcare costs.3 In the US alone, there are approximately 1.6-3.8 million sport concussions each year,4,5 where 50% of concussed athletes have at least one vestibular type symptom.6 Although the impact of cost has been demonstrated in older adults, the costs of concussion-related dizziness is much more difficult to calculate due simultaneously treating symptoms from multiple systems.
A common treatment for symptoms related to disorders of vestibular function is vestibular rehabilitation, a sub-specialty of physical therapy. These exercises are performed daily by Subjects at home and consist of visually fixating on a target while moving the head and/or the object on which the subject is fixating. To alter exercise difficulty, exercise parameters are altered including: visual background complexity (plain and dark, busy but stationary, moving objects, rapidly moving objects), postural positioning (seated, standing with a wide base of support, standing with a narrow base of support, standing on one leg), and duration of exercise (from 5 seconds to approximately 2 minutes). Early evidence shows that vestibular rehabilitation exercises provided by a physical therapist is an effective method of ameliorating vestibular hypofunction. Further, effectiveness of vestibular rehabilitation does not decline with increasing age of the patient,8 indicating benefit for all ages that are affected. Unfortunately, many factors limit the ability to determine efficiency and efficacy of treatment and have been highlighted in a recent clinical practice guideline9 and systematic review5,10. Limitations include: poor measurement of prescribed exercise compliance by depending on subjective report, inability to control for environmental factors during home program execution, and the influence of noxious vestibular input associated with traveling to attend scheduled physical therapy visits. These factors hinder performing high quality efficacy studies, resulting in exercise prescription being largely based on expert opinion, the lowest level on the hierarchy of evidence-based practice.11 In fact, current opinion indicates that exercises should be performed 3 times a day for a total of 12 minutes with each bout lasting approximately 2 minutes, all with no clear indication of speed and amplitude of performance. In this study, the investigators aim to use a commercially available virtual reality device to deliver usual vestibular rehabilitation exercises, while using the device's inbuilt sensors to accurately measure head movement, speed and duration. Using this device, the investigators will assess compliance and dose of exercises required to reduce symptoms of dizziness and imbalance and to determine if performing such exercises in a virtual reality environment will provide similar results to that usual rehabilitation techniques.
When a potential subject is identified, the subject will be screened for appropriateness of inclusion for this study. After informed consent has been obtained from a recruited subject, those with Unilateral Vestibular Hypofunction (UVH) will be asked to perform a 4-week intervention, while those with Bilateral Vestibular Hypofunction (BVH) or those post-concussion will each be asked to perform a 12-week intervention. Those with UVH will undergo a shorter intervention due to strong evidence that neural adaptation occurs much more quickly (usually 4 weeks) than those with BVH and history of concussion.9,10,17-19 The intervention will consist of physical therapy visits combined with a home program of specific vestibular exercises. Each subject will be asked to attend physical therapy visits at least one time per week throughout the 4- or 12-week period.
Assessments will be performed on all groups and consist of a combination of vestibulo-ocular assessment, balance and clinical functional outcome measures, and surveys of subject satisfaction. Subjects are randomly assigned to the usual rehabilitation or intervention group based on each of the following diagnostic categories.
The compliance to exercises will be obtained from a log in the virtual reality device for the VR group, and will be paper based for the usual physical therapy group. Subjects in the three intervention groups will be asked to perform the same type of exercises as the usual rehabilitation group, but using a virtual reality device that will be issued to the patient for home use. Subjects will use a custom designed program to perform the exercises using a commercially available virtual reality device (no specialized hardware or additions to the commercially available device will be performed). Subjects will be instructed on the first day in how to operate the Virtual Reality Vestibular Rehabilitation (VRVR) program and how to properly perform the exercises. The VRVR device and software will simulate a virtual reality 'room' with an 'X' fixed in front of a wall. There are six different background complexities. Exercise sessions will start seated upright in a chair and will progress to standing per the home exercise protocol. The system will prompt the patient to begin the exercise and will automatically log the frequency and duration of exercise performed. The system will ask the patient to rate the severity of their symptoms on a 0-10 scale before and after each bout of exercise. Subjects' instruction regarding initial dose and progression will be identical to those given in the usual rehabilitation group. Subjects will be asked to bring their device with them to their 4 week, 8 week, and 12 weeks appointment to transfer their de-identified data and to insure integrity of the data and device. Subjects will be asked to return the device at the end of the intervention period.
Per patient and therapist discretion, additional physical therapy visits may be scheduled to aid in patient understanding of exercise progression protocol, assess correct performance of exercise (with or without virtual reality device). Non-study related physical therapy visits may be scheduled between sessions in order to address impairments unrelated to vestibulo-ocular deficits. These may include interventions to address musculoskeletal deficits or other balance related impairments. Any additional sessions of physical therapy will be reported in order to determine possible confounding information.
There will be an additional group of healthy control subjects that will be tested for only one day. Healthy subjects will be recruited through flyers, approved email lists, and word of mouth in the general public. This healthy control group will perform the same tests as the other groups perform on Day 1. This group will be used to compare outcomes of usual rehabilitation and intervention groups, to the function of those without disorders of vestibular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Vestibular Rehabilitation Care | Active comparator | Behavioral: Gaze stabilization non-instrumentedParticipants 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. |
| Home Exercises Using Virtual Reality Device | Experimental | Device: Gaze stabilization Exercises using Virtual Reality DeviceParticipants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP. |
| Healthy Control | No 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. The healthy-control group will only be assessed at baseline (a single visit). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Known or suspected vestibular dysfunction
- Healthy volunteers without dizziness to serve as healthy control subjects
Key exclusion criteria (12 listed)
- Previous cerebrovacular accident (stroke)
- Reported neurologic or oculuomotor disease
- Taking of medications that affect the vestibular or oculomotor system.
- Current symptoms of benign paroxysmal positional hypofunction
- Concussion occuring less than 7 days prior to enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaze stabilization Exercises using Virtual Reality DeviceParticipants will utilize a wireless virtual reality headset to perform their gaze stabilization exercises to better control the background and visual field as well as collect data related to speed, excursion, and duration of head movements. | Device | Home Exercises Using Virtual Reality Device |
| Gaze stabilization non-instrumentedParticipants will perform gaze stabilization exercises in a non-instrumented manner. Subjects are instructed to focus on a letter on a piece of paper held at arm's length. They are instructed to move their head back and forth as quickly as they can while keeping the letter in focus. The total duration of the exercise (from 10 - 240 seconds) and background complexity (simple to complex moving) are increased gradually according to patient symptoms. | Behavioural | Usual Vestibular Rehabilitation Care |
Primary outcome
Dizziness Handicap Inventory
Time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Final score on the Dizziness Handicap Inventory. The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire used to measure a patient's self-perceived impact of dizziness on their daily life, divided into physical, emotional, and functional subscales. In this study, only the total score (sum of subscales) was used. To score the DHI, each of the 25 questions is answered with "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points), resulting in a total score from 0 to 100. A higher score indicates a greater perceived handicap, a lower score indicates less perceived handicap. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Head Impulse Test at Final Assessment
Time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Assessment of VOR-evoked gaze stability. The head impulse test (HIT) assesses the vestibulo-ocular reflex (VOR) to detect peripheral vestibular dysfunction, or a weakened balance system in the inner ear. In the test, the examiner quickly rotates a patient's head while the patient tries to keep their eyes fixed on a target. A normal response involves the eyes staying fixed on the target, but an abnormal test shows the eyes moving away with the head and then quickly "catching up" with a corrective saccade, indicating the VOR isn't keeping up. Count of participants enrolled in the study are those with a positive clinical finding. This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
3 secondary outcomes
Visual Vertigo Analogue Scale Final Assessment
Time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Functional Gait Assessment Final Assessment
Time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) Final Performance
Time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19468085Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
- Background: PubMed 11346317Sloane PD, Coeytaux RR, Beck RS, Dallara J. Dizziness: state of the science. Ann Intern Med. 2001 May 1;134(9 Pt 2):823-32. doi: 10.7326/0003-4819-134-9_part_2-200105011-00005.
- Background: PubMed 29512120Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.
- Background: PubMed 27655831Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
- Background: PubMed 22904209Kontos AP, Elbin RJ, Schatz P, Covassin T, Henry L, Pardini J, Collins MW. A revised factor structure for the post-concussion symptom scale: baseline and postconcussion factors. Am J Sports Med. 2012 Oct;40(10):2375-84. doi: 10.1177/0363546512455400. Epub 2012 Aug 16.
- Background: PubMed 23331774Alghadir AH, Iqbal ZA, Whitney SL. An update on vestibular physical therapy. J Chin Med Assoc. 2013 Jan;76(1):1-8. doi: 10.1016/j.jcma.2012.09.003. Epub 2012 Dec 26.
- Background: PubMed 12368616Whitney SL, Wrisley DM, Marchetti GF, Furman JM. The effect of age on vestibular rehabilitation outcomes. Laryngoscope. 2002 Oct;112(10):1785-90. doi: 10.1097/00005537-200210000-00015.
- Background: PubMed 26913496Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
- Background: PubMed 25581507McDonnell MN, Hillier SL. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Cochrane Database Syst Rev. 2015 Jan 13;1(1):CD005397. doi: 10.1002/14651858.CD005397.pub4.
- Background: PubMed 17419779Mantzoukas S. A review of evidence-based practice, nursing research and reflection: levelling the hierarchy. J Clin Nurs. 2008 Jan;17(2):214-23. doi: 10.1111/j.1365-2702.2006.01912.x. Epub 2007 Apr 5.
- Background: PubMed 12574761Cohen HS, Kimball KT. Increased independence and decreased vertigo after vestibular rehabilitation. Otolaryngol Head Neck Surg. 2003 Jan;128(1):60-70. doi: 10.1067/mhn.2003.23.
- Background: PubMed 26556560Bergeron M, Lortie CL, Guitton MJ. Use of Virtual Reality Tools for Vestibular Disorders Rehabilitation: A Comprehensive Analysis. Adv Med. 2015;2015:916735. doi: 10.1155/2015/916735. Epub 2015 Apr 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Goodman, DPT principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze stabilization Exercises using Virtual Reality Device and Gaze stabilization non-instrumented in people with Vestibular Disorder, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (time frame: This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851184, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.