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Recovery of Visual Acuity in People With Vestibular Deficits
This study is ongoing, but not recruiting participants.
First Received: December 12, 2006   No Changes Posted
Sponsors and Collaborators: Emory University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00411216
  Purpose

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 Intervention Phase
Unilateral Vestibular Hypofunction
Bilateral Vestibular Hypofunction
Behavioral: vestibular exercises
Behavioral: Vestibular neutral exercises
Phase II
Phase III

MedlinePlus related topics: Dizziness and Vertigo Exercise and Physical Fitness Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Recovery of Visual Acuity in Vestibular Deficits

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Visual acuity during head movement: Computerized Dynamic Visual Acuity test; measurement taken before intervention, at 2 and 4 weeks during intervention at at end of intervention

Secondary Outcome Measures:
  • Vestibular function: caloric test (pre-intervention); rotary chair test (pre- and post-intervention)
  • Subjective complaints: (all pre- and post-intervention):
  • disability scale
  • activities specific balance confidence scale
  • symptoms intensity for dizziness, oscillopsia, disequilibrium
  • Balance and Gait
  • fall risk (Dynamic Gait Index)
  • Eye movements: scleral search coil

Estimated Enrollment: 98
Study Start Date: August 2000
Estimated Study Completion Date: December 2004
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’.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411216

Locations
United States, Georgia
Center for Rehabilitation Medicine, Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Susan J Herdman, PhD Emory University
  More Information

Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: RO1-DC 03196, NIH (NIDCD)ID:RO1-DC 03196, IRB ID:501-2000
Study First Received: December 12, 2006
Last Updated: December 12, 2006
ClinicalTrials.gov Identifier: NCT00411216     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
vestibular rehabilitation
vestibular hypofunction

ClinicalTrials.gov processed this record on May 06, 2009