Recovery of Visual Acuity in People With Vestibular Deficits

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ClinicalTrials.gov Identifier: NCT00411216

Recruitment Status : Completed

First Posted : December 13, 2006

Results First Posted : July 21, 2014

Last Update Posted : August 7, 2015

Sponsor:

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Information provided by (Responsible Party):

Susan Herdman, Emory University

Study Description

Brief Summary:

The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. We hypothesize that the performance of specific adaptation and substitution exercises will result in an improvement in visual acuity during head movements while those patients performing placebo exercises will show no improvement.

Condition or disease	Intervention/treatment	Phase
Vestibular Neuronitis Vestibular Neuronitis, Bilateral Vestibular Schwannoma	Other: Control exercises Other: gaze stabilization exercises	Not Applicable

Detailed Description:

Decrements in visual acuity during head movement in patients with vestibular hypofunction are potentially serious problems. This deficit could contribute to decreased activity level, avoidance of driving with resultant diminished independence and, ultimately, limited social interactions and increased isolation. Oscillopsia occurs because of inadequate vestibulo-ocular reflex (VOR) gain and suggests that compensation for the vestibular loss has not occurred. The purpose of this study was to examine the effect of an exercise intervention on visual acuity during head movement in patients with unilateral and bilateral vestibular hypofunction. We hypothesized that 1) patients performing vestibular exercises would have improved visual acuity during head movement compared to patients performing placebo exercises; 2) there would be no correlation between dynamic visual acuity (DVA) and the patients' subjective complaints of oscillopsia; and 3) improvement in DVA would be reflected by changes in residual vestibular function as indicated by an increase in VOR gain.

Patients are assigned randomly to either the vestibular exercise or placebo exercise group. The randomization schedule is generated using a computer program for 2-sample randomization. The sequence was not concealed from the investigator who obtained consent from the subjects and supervised the exercises (SJH). The group assignment (vestibular exercise or placebo exercise) was concealed from the participants and from the investigator who performed the outcome measures.

The vestibular exercise group practiced exercises that consisted of adaptation exercises and eye-head exercises to targets (Table 1), which were designed to improve gaze stability 16. They also performed gait and balance exercises. The placebo exercise group performed exercises designed to be 'vestibular-neutral'.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	23 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Recovery of Visual Acuity in Vestibular Deficits
Study Start Date :	August 2000
Actual Primary Completion Date :	December 2004
Actual Study Completion Date :	December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Exercise and Physical Fitness

Genetic and Rare Diseases Information Center resources: Acoustic Neuroma Schwannoma Guillain-Barre Syndrome Neuroendocrine Tumor Neuroepithelioma Neurofibroma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: exercises for gaze stabilization Experimental group performed vestibular adaptation and substitution exercises	Other: gaze stabilization exercises adaptation and substitutin exercises encorporating retinal lsip and head movements
Placebo Comparator: Control exercises Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements	Other: Control exercises saccadic eye movements against a plain background; no head movements

Outcome Measures

Primary Outcome Measures :

Change in Visual Acuity During Head Movement From Baseline to Discharge [ Time Frame: pre-intervention and at discharge ]
visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.

The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention).
Subjective Complaints: (All Pre- and Post-intervention): [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
questionnaire

Secondary Outcome Measures :

Disability Scale [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
questionnaire
Activities Specific Balance Confidence Scale [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
questionnaire
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
visual analoque scales
Balance and Gait [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
gait speed
Fall Risk (Dynamic Gait Index) [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ]
performance test
Eye Movements: Scleral Search Coil [ Time Frame: pre- and post-treatment ]
eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient had to have either a unilateral vestibular or bilateral vestibular hypofunction defined as follows: Unilateral vestibular deficits were defined by a > 25% difference in slow phase eye velocity between right and left sides on either the caloric or rotary chair test. Bilateral vestibular deficits were defined included refixation saccades made in response to unpredictable head thrusts to the right and left, a gain < .1 on rotary chair step test and a peak slow phase eye movement of <5 degrees/sec during irrigation of each ear on bithermal water caloric testing
Healthy subjects with normal vestibular function test results
must be able to complete DVA test

Exclusion Criteria:

Patients with central lesions will be omitted from the study because vestibular adaptation or other compensatory mechanisms may be compromised and
Patients with visual acuity when the head is stationary of 20/60 or worse.
Patients on medication that suppress or facilitate vestibular function will not be excluded from the study but data will be analyzed to assess the effect of medication.
Patient who do not understand the purpose of the study and what it involves

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411216

Locations


United States, Georgia
Center for Rehabilitation Medicine, Emory University
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators


Principal Investigator:	Susan J Herdman, PhD	Emory University

More Information

Publications of Results:

Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6.

Herdman SJ, Schubert MC, Tusa RJ. Role of central preprogramming in dynamic visual acuity with vestibular loss. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1205-10.

Schubert MC, Herdman SJ, Tusa RJ. Functional measure of gaze stability in patients with vestibular hypofunction. Ann N Y Acad Sci. 2001 Oct;942:490-1.

Schubert MC, Herdman SJ, Tusa RJ. Vertical dynamic visual acuity in normal subjects and patients with vestibular hypofunction. Otol Neurotol. 2002 May;23(3):372-7.

Herdman SJ, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in unilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):819-24.

Schubert MC, Das V, Tusa RJ, Herdman SJ. Cervico-ocular reflex in normal subjects and patients with unilateral vestibular hypofunction. Otol Neurotol. 2004 Jan;25(1):65-71.

Hall CD, Schubert MC, Herdman SJ. Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. Otol Neurotol. 2004 Sep;25(5):746-51.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Herdman SJ, Hall CD, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in bilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):383-9.


Responsible Party:	Susan Herdman, Professor, Emory University
ClinicalTrials.gov Identifier:	NCT00411216 History of Changes
Other Study ID Numbers:	IRB00000336 R01DC003196 ( U.S. NIH Grant/Contract )
First Posted:	December 13, 2006 Key Record Dates
Results First Posted:	July 21, 2014
Last Update Posted:	August 7, 2015
Last Verified:	July 2015

Keywords provided by Susan Herdman, Emory University:


vestibular rehabilitation vestibular hypofunction

Additional relevant MeSH terms:


Neurilemmoma Neuroma, Acoustic Vestibular Neuronitis Guillain-Barre Syndrome Neuritis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neuroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Nervous System Neoplasms	Neoplasms by Site Peripheral Nervous System Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases Nervous System Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Demyelinating Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Polyneuropathies

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