Dose of Vestibular Rehabilitation for Vestibular Hypofunction

NCT04851184 | Terminated Results FDA Device

• 1 other identifier: NCR180548
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Vestibular Disorder

Keywords

gaze stability; vestibular hypofunction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

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

Study Arms (3)

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.

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.

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).

Interventions

Gaze stabilization Exercises using Virtual Reality Device 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.

Home Exercises Using Virtual Reality Device

Gaze stabilization non-instrumented BEHAVIORAL

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.

Usual Vestibular Rehabilitation Care

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

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

Washington D.C., District of Columbia, 20006, United States

Location

Related Publications (17)

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  PMID: 19468085 BACKGROUND

• Sloane 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.

  PMID: 11346317 BACKGROUND

• Florence 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.

  PMID: 29512120 BACKGROUND

• Murray 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.

  PMID: 27655831 BACKGROUND

• Kontos 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.

  PMID: 22904209 BACKGROUND

• Alghadir 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.

  PMID: 23331774 BACKGROUND

• Whitney 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.

  PMID: 12368616 BACKGROUND

• Hall 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.

  PMID: 26913496 BACKGROUND

• McDonnell 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.

  PMID: 25581507 BACKGROUND

• Mantzoukas 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.

  PMID: 17419779 BACKGROUND

• Cohen 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.

  PMID: 12574761 BACKGROUND

• Bergeron 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.

  PMID: 26556560 BACKGROUND

• Micarelli 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.

  PMID: 28723718 BACKGROUND

• Rosiak 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.

  PMID: 30714985 BACKGROUND

• Alahmari 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.

  PMID: 24608691 BACKGROUND

• Hillier SL, McDonnell M. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Clin Otolaryngol. 2011 Jun;36(3):248-9. doi: 10.1111/j.1749-4486.2011.02309.x. No abstract available.

  PMID: 21752206 BACKGROUND

• Cohen HS, Gottshall KR, Graziano M, Malmstrom EM, Sharpe MH, Whitney SL; Barany Society Ad Hoc Committee on Vestibular Rehabilitation Therapy. International guidelines for education in vestibular rehabilitation therapy. J Vestib Res. 2011;21(5):243-50. doi: 10.3233/VES-2011-0424.

  PMID: 22101295 BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

The intervention's effect cannot be determined because the study terminated early before recruiting adequate intervention groups.

Results Point of Contact

• Title: Karen Goodman
• Organization: George Washington University

karengoodman@gwu.edu

202-994-0705

Study Officials

• Karen Goodman, DPT

  The George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 20, 2021
• Study Start: March 22, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)