Skip to main content
OpenTrials
Completed

NCT Number: NCT00411216

Recovery of Visual Acuity in People With Vestibular Deficits

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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'.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Exercises

Other

saccadic eye movements against a plain background; no head movements

gaze stabilization exercises

Other

adaptation and substitutin exercises encorporating retinal lsip and head movements

Primary outcomes

  1. 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).

  2. Subjective Complaints: (All Pre- and Post-intervention):

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    questionnaire

Secondary outcomes

  1. Disability Scale

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    questionnaire

  2. Activities Specific Balance Confidence Scale

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    questionnaire

  3. Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    visual analoque scales

  4. Balance and Gait

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    gait speed

  5. Fall Risk (Dynamic Gait Index)

    Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

    performance test

  6. 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Recovery of Visual Acuity in Vestibular Deficits

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Dec 13, 2006
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.