Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Perturbed Stance Postural Control
研究概览
简要总结
The nervous system responds to changes in external or internal conditions by altering the behavior of neurons through multiple forms of neural plasticity. A specific form of plasticity, "homeostatic plasticity", stabilizes neural activity by driving the excitability of neurons toward a "set-point" level of activity. Over the last six years, new data have come to light showing that the vestibular system also possess a robust capacity to modulate sensitivity to self-motion cues in response to prolonged periods of motion. Collectively, these studies have demonstrated a capacity to use motion perturbations (i.e., low, or high levels of vestibular stimulation) to dynamically adjust the sensitivity of the vestibular system on both the single neuron and behavioral levels. The ability to use subthreshold motion stimuli to drive plasticity in the vestibular system motivates this study. The investigators aim to determine the impact of subthreshold motion on (a) balance performance and (b) balance training in individuals with peripheral vestibular hypofunction.
详细描述
The investigators aim to test (1) if sub threshold motion improves motion perception, (2) if sub threshold motion improves balance performance, and (3) if sub threshold motion prior to balance training leads to improved balance performance. Twenty-four subjects with peripheral vestibular hypofunction (12 with bilateral and 12 with unilateral hypofunction) and twenty-four healthy control participants will complete the study. Each participant will complete four visits to the laboratory. Day 1 will measure the capacity to modify balance and self-motion perception after a single block of subthreshold motion, including any retention effects after a washout period. Days 2-4 will be performed in random order and will test changes in balance and self-motion perception after (a) repeated balance training, (b) repeated subthreshold motion, and (c) balance training combined with sub threshold motion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants will complete all elements of the study. However, they will be blinded to the nature of each day of the study (i.e., will be unaware of participation in a "sham" vs. "motion" stimulus).
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Bilateral Vestibular Hypofunction:
- •1. Bilateral lateral canal VOR gain of < 0.8 on video head impulse testing OR bilateral positive bedside head impulse test
- •Inclusion Criteria for Unilateral Vestibular Hypofunction:
- •1. Unilateral yaw aVOR gain of < 0.8 on video head impulse testing OR unilateral positive bedside head impulse test
- •Inclusion Criteria for all Participants:
- •Must be able to stand for 5 minutes unassisted
- •No leg or foot amputations
- •No lower limb braces
- •Not currently pregnant by self-report
- •Weight <= 300 pounds (due to limitations of testing equipment)
排除标准
- •for all participants:
- •Severe head trauma or traumatic brain injury
- •History of seizures
- •Alternative neurologic illness or condition known to impact vestibular or balance function (e.g., stroke, neurodegenerative disorders, demyelinating illness)
- •Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
- •Any of the following eye diseases or conditions: amblyopia (or "lazy eye") or history of amblyopia, diagnosis of age- related macular degeneration, retina dystrophy, glaucoma, cataracts,
- •Recent (<6 months) orthopedic injury that may affect test performance
- •Recent surgery (< 6 months) that may impact test performance.
- •Other severe health problems (heart disease, pulmonary disease, cancer, etc.) that may affect test performance
- •Due to potentially nauseogenic nature of some motions and to protect fetus and mother, pregnant women will also be excluded from this study
- •Since the investigators cannot address every possible potential individual recruit in advance, additional exclusion criteria may be required.
研究组 & 干预措施
Balance training performed with and without added subthreshold conditioning.
Each participant in this single group design will complete the same three conditions of the experiment in a randomized order.
干预措施: Subthreshold Vestibular Conditioning (Behavioral)
Balance training performed with and without added subthreshold conditioning.
Each participant in this single group design will complete the same three conditions of the experiment in a randomized order.
干预措施: Balance Training (Behavioral)
Balance training performed with and without added subthreshold conditioning.
Each participant in this single group design will complete the same three conditions of the experiment in a randomized order.
干预措施: Balance Training Plus Subthreshold Conditioning (Other)
结局指标
主要结局
Perturbed Stance Postural Control
时间窗: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
The RMSD of mediolateral (ML) and anteroposterior (AP) postural sway will be measured in response to pseudorandom two-dimensional mediolateral and anteroposterior tilts of the support surface delivered using a 6DoF motion platform. Participants will stand with eyes closed and feet at a standardized distance on top of the motion platform. The platform will tilt simultaneously in both the roll and pitch planes, with each plane of tilt having independent frequency spectra (\~0.08 to 1 Hz). The perturbation test will last approximately 2 minutes.
Vestibular Perceptual Thresholds - 0.5Hz Roll Tilt
时间窗: At each of the 4 visits, outcome measures will be captured at (1) beginning of the visit (i.e., baseline), (2) post-intervention (20 minutes after baseline), and (3) post-washout (20 minutes after the post-intervention assessment).
Vestibular perceptual thresholds will be measured using a forced-choice direction recognition task using methods that the investigators have used extensively. Subjects will be tilted in the coronal plane (i.e., roll tilt) in one of two directions (e.g., towards the left or right) in complete darkness while seated on a 6DoF platform. To mask potential auditory directionality cues, auditory "noise" - uncorrelated with motion (amplitude, direction, or type) - will be applied at approximately 60 dB SPL. Motion stimuli will consist of single cycles of sinusoidal acceleration. After each motion, the participant will be asked to judge the direction of the tilt stimulus, with the threshold being defined as the smallest velocity of tilt that can be accurately perceived.
次要结局
未报告次要终点