High-precision Immersive Robotic Environment for Sensorimotor Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
研究概览
简要总结
This is a preliminary study to determine the reliability and validity of new tests of orientation and balance, as well as to test the effects of a new treatment for visually induced dizziness. Tests involve determining vertical alignment. The treatment is task-based and involves focusing attention on internal body sensations to help improve the sense of upright. Testing is done twice before and twice after treatment, which is provided twice-weekly during a three-week period between testing. The total time participants are involved in the study is approximately six weeks.
详细描述
Falls are a major concern for people living in countries all over the world. Tens of millions of people who fall are seriously injured and hundreds of thousands of people who fall die every year. People who are dizzy are far more likely to fall. The investigators are particularly interested in working with people who have dizziness that is caused by watching motion or looking at complex patterns (e.g. checkerboard patterns, walking through grocery store aisles, riding in vehicles, or watching movies).
This type of dizziness or vertigo is typically described as motion sickness or, more specifically, visually-induced dizziness. This problem affects adults who are healthy and adults who have a variety of health conditions. No diagnostic tests for this condition exist at this time and the treatments currently being used may result in worsening dizziness for some patients.
New tests were created for orientation and balance, as well as a new treatment for visually-induced dizziness. This is a preliminary study of the reliability and validity of the tests we developed, as well as whether the new treatment created results in reduced dizziness, improved balance, and changes in daily functioning.
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. It is hypothesized that the new tests will be accurate and able to detect problems in impaired adults. Additionally, that the treatment will result in less dizziness, better balance, and reduced risk of falling.
The plan is to enroll a total of 30 people in this study, 15 who are healthy and 15 who have visually-induced dizziness due to a vestibular (inner ear) problem. Each participant will complete several questionnaires and tests of balance performance before and after undergoing the treatment. Participants attend 8 visits over 6 weeks. Each study visit lasts approximately 60 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
It is not possible to mask this behavioral intervention. The study team small; thus, masking of the study team is also not possible.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants:
- •Inclusion Criteria: Participants must
- •have normal self-reported cognitive function
- •speak English fluently
- •weigh less than 225 pounds and be less than 6'4"
- •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 this protocol
排除标准
- •Participants must not
- •be pregnant or planning to become pregnant while in "on study" status
- •have best-corrected visual acuity > 20/70
- •have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- •have peripheral neuropathy
- •have a self-reported history of frequent syncope (>1/month)
- •Participants with Visually-induced Dizziness:
- •Inclusion Criteria: Participants must
- •have self-reported symptoms of visually-induced dizziness
- •have normal self-reported cognitive function
- •speak English fluently
- •weigh less than 225 pounds and be less than 6'4"
- •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 this protocol
- •Exclusion Criteria: Participants must not
- •be participating in vestibular and balance rehabilitation therapy and/or be pregnant or planning to become pregnant while in "on study" status
- •have best-corrected visual acuity > 20/70
- •have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
- •have peripheral neuropathy, and/or 5) have a self-reported history of frequent syncope (>1/month)
研究组 & 干预措施
Healthy
Healthy adults with visually-induced dizziness with undergo the testing and treatment.
干预措施: Sensory re-weighting (Behavioral)
Vestibular-impaired
Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.
干预措施: Sensory re-weighting (Behavioral)
结局指标
主要结局
Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height
时间窗: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
This test is designed to assess balance during quiet standing in different sensory conditions. Participants perform one trial (lasting 30 seconds) of each condition. All trials are performed while standing on a force plate with the feet in a self-selected, comfortable position. The visual environment is controlled using an Oculus Rift. The surface conditions are either non-compliant or compliant. The frequency-dependent height of the Intersection Point (IP) of the ground reaction force is the main metric. The overall height of the IP curve obtained while the participant stands on a firm surface with their eyes open is the primary outcome. The height of IP ranges from 0 to 4.0, and higher values represent greater stability.
Rod and Frame Test (RFT) Mean Performance
时间窗: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be projected inside a tilted frame within the central portion of the visual field. The surrounding virtual environment will be void. The frame will be tilted by +/- 20° in the frontal plane. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, mean performance in this population is 6.51 (sd 7.8). Higher values indicate greater deviations of perceived vertical from earth vertical.
Rod and Disk Test (RDT) Mean Performance
时间窗: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
Subjective Visual Vertical (SVV) Mean Performance
时间窗: Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)
An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.
次要结局
- Vision-related Dizziness Questionnaire (VRDQ) Total Score(Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5))
- Dizziness Handicap Inventory (DHI) Total Score(Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5))