Dose of Vestibular Rehabilitation for Vestibular Hypofunction (VRVR)

December 2, 2025 updated by: Keith Cole, George Washington University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20006
        • The George Washington University, Department of Health, Human Function and Rehabilitation Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Known or suspected vestibular dysfunction
  • Healthy volunteers without dizziness to serve as healthy control subjects

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Vestibular Rehabilitation Care
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.
Behavioral: Gaze stabilization non-instrumented
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.
Experimental: Home Exercises Using Virtual Reality Device
Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.
Device: Gaze stabilization Exercises using Virtual Reality Device
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.
No Intervention: Healthy Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
This measure is assessed from 0 to 12 weeks in Intervention Arms; Assessed at a single Baseline timepoint for Healthy Controls.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: Karen Goodman, DPT, The George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCR180548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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