Recovery of Visual Acuity in Vestibular Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Visual Acuity During Head Movement From Baseline to Discharge
研究概览
简要总结
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.
详细描述
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'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Visual Acuity During Head Movement From Baseline to Discharge
时间窗: 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).
Subjective Complaints: (All Pre- and Post-intervention):
时间窗: pre-intervention, 2 weeks, 4 weeks and at discharge
questionnaire
次要结局
- Disability Scale(pre-intervention, 2 weeks, 4 weeks and at discharge)
- Activities Specific Balance Confidence Scale(pre-intervention, 2 weeks, 4 weeks and at discharge)
- Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium(pre-intervention, 2 weeks, 4 weeks and at discharge)
- Balance and Gait(pre-intervention, 2 weeks, 4 weeks and at discharge)
- Fall Risk (Dynamic Gait Index)(pre-intervention, 2 weeks, 4 weeks and at discharge)
- Eye Movements: Scleral Search Coil(pre- and post-treatment)