Sensory Re-weighting Training for Orientation and Equilibrium: A Pilot Trial for the Treatment of Visually-induced Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Post-Intervention Virtual Reality Sickness Questionnaire (VRSQ) Score
研究概览
简要总结
This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. The researchers will use the new tests and treatments with adults who are affected by visually-induced dizziness. Testing is done twice before and once after treatment. The total time participants are involved in the study is approximately two weeks.
详细描述
This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. It is not known whether the new tests of orientation and balance are better, worse, or the same as existing tests in the ability to detect problems, nor is it known if the new treatment technique is any better, worse, or the same as existing treatments for dizziness and imbalance. However, the researchers hypothesize that the new tests will improve the ability to detect problems. They hypothesize that the treatment will result in less dizziness, better balance, and reduced risk of falling for those who receive it and that it is a better alternative to treatments that are already available to patients.
In order to see if this is true, the researchers will use the new tests and treatments with adults who are affected by dizziness. All participants in this study will undergo the same tests and will receive the same treatment. Testing is done twice before and once after the treatment period. The tests and treatment are done while standing on a computerized platform that measures balance and can tilt people from side to side. During these study procedures, participants wear virtual reality goggles that show them simple images in an otherwise dark environment.
The goal of the tests and the treatment is for participants to use what they feel to help them decide if the images shown inside the goggles are aligned with the person's sense of gravity. Participation in this study is voluntary and people who decide to participate may stop at any time without penalty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking is not practical for this pilot trial.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have self-reported symptoms of visually-induced dizziness
- •Participants must have normal self-reported cognitive function
- •Participants must speak English fluently
- •Weigh less than 225 pounds
- •Be able to support their body weight in an upright posture for 15 minutes at a time
- •Be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in the study protocol.
排除标准
- •Participants must not be participating in vestibular and balance rehabilitation therapy
- •Pregnant or planning to become pregnant while in "on study" status
- •Best-corrected visual acuity > 20/70
- •Any self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- •Peripheral neuropathy
- •Self-reported history of frequent syncope (>1/month).
结局指标
主要结局
Post-Intervention Virtual Reality Sickness Questionnaire (VRSQ) Score
时间窗: Visit 3 (Week 2)
This questionnaire will be administered on paper immediately following each instance of testing and each round of training. Additional rest time will be required if participants symptoms are scored as \> 33% on the VRSQ (see below for more information regarding VRSQ scoring). Symptoms must return to baseline before participants are permitted to begin a round of testing or training. The VRSQ is comprised of nine items from two domains (oculomotor: general discomfort, fatigue, eye strain, and difficulty focusing; disorientation: headache, fullness of head, blurred vision, dizzy (eyes closed), and vertigo). The intensity of each item is rated on a 4-point Likert scale: 0 = not at all, 1 = slightly, 2 = moderately, and 3 = very. Scores for each sub-scale and the total score range from 0 to 100. Higher scores indicate greater symptom intensity. The VRSQ is an adaptation of the Simulator Sickness Questionnaire (SSQ) for use in virtual environments.
Percent of Participants Enrolled Relative to Approached
时间窗: Up to 30 minutes
Study feasibility is a primary outcome of this study. Feasibility will be measured using enrollment rates: the number of participants enrolled relative to the number of potential participants approached. This study will be considered 'feasible' with an enrollment rate higher than 70%
Participant Drop out Rate
时间窗: Up to 3 weeks
Tolerance of the intervention is a primary outcome of this study. Tolerance will be measured using the participant drop out rate. This study will be considered tolerable if the drop out rate is less than 20%
次要结局
- Change in Rod and Frame Test (RFT) Mean Performance(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))
- Change in Motion Sensitivity Assessment Questionnaire (MSAQ) Overall Score(Visit 1 (Week 1) and Visit 3 (Week 2))
- Change in Visual Vertical Analogue Scale (VVAS) Total Score(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))
- Change in Rod and Disk Test (RDT) Mean Performance(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))
- Change in Multisensory Balance Evaluation (MBE) as measured by the Intersection Point Height(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))
- Change in Subjective Visual Vertical (SVV) Mean Performance(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))
- Change in Semmes-Weinstein Monofilament Examination (SWME) Discrimination Threshold(Visit 2 (in Week 2) and Visit 3 (in Week 2))
- Change in Vision-related Dizziness Questionnaire (VRDQ) Total Score(Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2))