Recovery of Visual Acuity in People With Vestibular Deficits
Primary Purpose
Vestibular Neuronitis, Vestibular Neuronitis, Bilateral, Vestibular Schwannoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control exercises
gaze stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Neuronitis focused on measuring vestibular rehabilitation, vestibular hypofunction
Eligibility 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
Sites / Locations
- Center for Rehabilitation Medicine, Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exercises for gaze stabilization
Control exercises
Arm Description
Experimental group performed vestibular adaptation and substitution exercises
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
Outcomes
Primary Outcome Measures
Change in Visual Acuity During Head Movement From Baseline to 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):
questionnaire
Secondary Outcome Measures
Disability Scale
questionnaire
Activities Specific Balance Confidence Scale
questionnaire
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
visual analoque scales
Balance and Gait
gait speed
Fall Risk (Dynamic Gait Index)
performance test
Eye Movements: Scleral Search Coil
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
Full Information
NCT ID
NCT00411216
First Posted
December 12, 2006
Last Updated
July 16, 2015
Sponsor
Emory University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00411216
Brief Title
Recovery of Visual Acuity in People With Vestibular Deficits
Official Title
Recovery of Visual Acuity in Vestibular Deficits
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
No
5. 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.
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'.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuronitis, Vestibular Neuronitis, Bilateral, Vestibular Schwannoma
Keywords
vestibular rehabilitation, vestibular hypofunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercises for gaze stabilization
Arm Type
Experimental
Arm Description
Experimental group performed vestibular adaptation and substitution exercises
Arm Title
Control exercises
Arm Type
Placebo Comparator
Arm Description
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
Intervention Type
Other
Intervention Name(s)
Control exercises
Intervention Description
saccadic eye movements against a plain background; no head movements
Intervention Type
Other
Intervention Name(s)
gaze stabilization exercises
Intervention Description
adaptation and substitutin exercises encorporating retinal lsip and head movements
Primary Outcome Measure Information:
Title
Change in Visual Acuity During Head Movement From Baseline to Discharge
Description
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).
Time Frame
pre-intervention and at discharge
Title
Subjective Complaints: (All Pre- and Post-intervention):
Description
questionnaire
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Secondary Outcome Measure Information:
Title
Disability Scale
Description
questionnaire
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Title
Activities Specific Balance Confidence Scale
Description
questionnaire
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Title
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
Description
visual analoque scales
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Title
Balance and Gait
Description
gait speed
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Title
Fall Risk (Dynamic Gait Index)
Description
performance test
Time Frame
pre-intervention, 2 weeks, 4 weeks and at discharge
Title
Eye Movements: Scleral Search Coil
Description
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
Time Frame
pre- and post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Herdman, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Rehabilitation Medicine, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9831156
Citation
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.
Results Reference
result
PubMed Identifier
11587600
Citation
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. doi: 10.1001/archotol.127.10.1205.
Results Reference
result
PubMed Identifier
11710496
Citation
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. doi: 10.1111/j.1749-6632.2001.tb03777.x. No abstract available.
Results Reference
result
PubMed Identifier
11981398
Citation
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. doi: 10.1097/00129492-200205000-00025.
Results Reference
result
PubMed Identifier
12925338
Citation
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. doi: 10.1001/archotol.129.8.819.
Results Reference
result
PubMed Identifier
14724495
Citation
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. doi: 10.1097/00129492-200401000-00013.
Results Reference
result
PubMed Identifier
15354006
Citation
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. doi: 10.1097/00129492-200409000-00017.
Results Reference
result
PubMed Identifier
17438254
Citation
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. doi: 10.1001/archotol.133.4.383.
Results Reference
derived
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Recovery of Visual Acuity in People With Vestibular Deficits
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