CompletedNCT00411216Updated Aug 7, 2015Results posted

Recovery of Visual Acuity in People With Vestibular Deficits

An interventional study of Control exercises and gaze stabilization exercises in Vestibular Neuronitis, Vestibular Neuronitis, Bilateral and Vestibular Schwannoma, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-07.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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'.

Conditions studied

Vestibular Neuronitis
Vestibular Neuronitis, Bilateral
Vestibular Schwannoma

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Keywords

vestibular rehabilitation
vestibular hypofunction

In context

Vestibular Neuronitis

34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.

This study's enrollment of 23 is below the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.

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Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.

Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 23 participants (actual)

Study arms

Experimental
exercises for gaze stabilization
Experimental group performed vestibular adaptation and substitution exercises
Other: gaze stabilization exercises
Placebo comparator
Control exercises
Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
Other: Control exercises

Interventions

OtherControl exercises
saccadic eye movements against a plain background; no head movements
Othergaze stabilization exercises
adaptation and substitutin exercises encorporating retinal lsip and head movements

What researchers measure

Primary outcomes

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).
Time frame: pre-intervention and at discharge
Subjective Complaints: (All Pre- and Post-intervention):
questionnaire
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge

Secondary outcomes

Disability Scale
questionnaire
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Activities Specific Balance Confidence Scale
questionnaire
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
visual analoque scales
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Balance and Gait
gait speed
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Fall Risk (Dynamic Gait Index)
performance test
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
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
Time frame: pre- and post-treatment

Results

Posted Jul 21, 2014

Participant flow

Participant flow — Overall Study
Milestone	Exercises for Gaze Stabilization	Control Exercises
Started	13	10
Completed	13	8
Not completed	0	2
Withdrew: Ten participants were entered into the c	0	2

Outcome measures

PrimaryChange 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).

Time frame:: pre-intervention and at discharge
Reported as:: Mean · LogMAR

Change in Visual Acuity During Head Movement From Baseline to Discharge
LogMAR	Exercises for Gaze Stabilization	Control Exercises
Change in Visual Acuity During Head Movement From Baseline to Discharge	0.198 ± 0.101	.296 ± .122

PrimarySubjective Complaints: (All Pre- and Post-intervention):

questionnaire

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