Recovery of Visual Acuity in People With Vestibular Deficits
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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 |
|---|---|
|
Vestibular Neuronitis Vestibular Neuronitis, Bilateral Vestibular Schwannoma |
Other: Control exercises Other: gaze stabilization exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Recovery of Visual Acuity in Vestibular Deficits |
- 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 [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: No ]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
- Vestibular function: caloric test (pre-intervention); rotary chair test (pre- and post-intervention) [ Time Frame: caloric test: pre-intervention; rotary chair test pre- and post-intervention ] [ Designated as safety issue: No ]bithermal caloric test; step rotations at 60 and 240 degrees per second rotary chair tests
- Subjective complaints: (all pre- and post-intervention): [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: No ]questionnaire
- disability scale [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: No ]questionnaire
- activities specific balance confidence scale [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: No ]questionnaire
- symptoms intensity for dizziness, oscillopsia, disequilibrium [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: No ]visual analoque scales
- Balance and Gait [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: Yes ]gait speed
- fall risk (Dynamic Gait Index) [ Time Frame: pre-intervention, 2 weeks, 4 weeks and at discharge ] [ Designated as safety issue: Yes ]performance test
- Eye movements: scleral search coil [ Time Frame: pre- and post-treatment ] [ Designated as safety issue: Yes ]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
| Enrollment: | 98 |
| Study Start Date: | August 2000 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 |
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| United States, Georgia | |
| Center for Rehabilitation Medicine, Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Susan J Herdman, PhD | Emory University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susan Herdman, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00411216 History of Changes |
| Other Study ID Numbers: | RO1-DC 03196, R01DC003196 |
| Study First Received: | December 12, 2006 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
vestibular rehabilitation vestibular hypofunction |
Additional relevant MeSH terms:
|
Neurilemmoma Neuroma, Acoustic Guillain-Barre Syndrome Neuritis Vestibular Neuronitis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neuroma Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms by Site Cranial Nerve Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Demyelinating Diseases Polyneuropathies |
ClinicalTrials.gov processed this record on May 23, 2013