Head-Mounted Vibrotactile Prosthesis for Patients with Chronic Postural Instabili

描述（由申请人提供）：基于微机电系统（MEMS）的惯性仪器在尺寸和性能方面的最新进展使得能够开发平衡假体，以向患有慢性平衡功能障碍的患者提供关于头部方向的反馈。需要平衡假体来帮助患有这种慢性平衡障碍的患者，以及需要能够通过训练促进这种障碍的康复的装置。本文提出的一体式、非侵入性和离散的BALCAP假体通过简单、可调节或重新调整的帽子提供了满足这两种要求的可能性，有不同的风格/颜色可供选择。使用BALCAP假体，通过帽带触觉器直接向头部提供低振幅振动触觉提示，帽带触觉器为佩戴者提供关于俯仰和滚转平面中头部倾斜的反馈，无论他/她是静止还是移动。 为了评估所提出的BALCAP平衡假体的效用，患有慢性平衡功能障碍的患者跨越一系列病因（例如，外周功能障碍、中枢功能障碍和多因素不平衡，也称为老化不平衡）将经历姿势稳定性和步态评估以确定该装置是否提供：（1）辅助益处;即，当BALCAP被启用与被禁用时显著改善了评估分数;以及（2）康复益处;即，在启用设备的情况下进行6周康复训练后，当BALCAP被禁用（关闭）时，评估评分显著改善。关于第一个假设，提议团队先前的工作证明了基于第一代头戴式振动触觉假体的双侧前庭丧失（BVL）患者的姿势稳定性的显著辅助改善。拟议的工作将评估这种平衡假体在慢性不平衡患者人群中的辅助功效，这些患者的疾病病因范围比先前研究中所述的更广，纳入其中将大大扩大商业市场的规模。 关于第二个假设，一个研究小组发表的研究结果支持这样一种观点，即使用这种替代感觉通道的康复训练可以导致训练后残余平衡改善的保持。然而，一个独立的研究小组发表了直接矛盾的发现，至少是关于BVL患者的发现。为了协调这些不同的结果，本文提出的工作还将基于包括静态和动态锻炼的6周结构化训练方案来研究BALCAP设备的康复潜力。如果通过康复训练来保持剩余平衡是可能的，那么将训练扩展到包括静态和动态活动最有可能使其变得明显。 如果关于辅助益处的假设得到支持，则头戴式振动触觉假体产品将能够为大量慢性姿势不稳定患者提供即时益处。如果康复训练能够实现剩余平衡保持，这将开辟新的研究领域，例如如何优化训练以最大限度地提高剩余平衡保持。 公共卫生相关性：预计这项研究产生的产品将为慢性姿势不稳定患者提供显着益处，帮助他们改善静态和动态活动的平衡，使他们能够更正常地发挥作用。简单、一体式、非侵入性、谨慎和低成本的平衡假体的可用性将提高平衡障碍患者的生活质量，并可能导致该领域的进一步发展。在家庭内外使用这种设备作为辅助工具，可以产生即时（辅助）和长期（康复）效益。辅助假肢还可以让患者在进行正常活动（与结构化锻炼相反）的同时进行“训练”，从而大大减轻患者的负担。

DESCRIPTION (provided by applicant): Recent advances in the size and performance of micro-electromechanical systems (MEMS)-based inertial instruments enable the development of a balance prosthesis to provide feedback regarding head orientation to patients with chronic balance dysfunction. There is a need for balance prostheses to assist patients with such chronic balance disorders, as well for devices that can facilitate rehabilitation of such disorders through training. The one-piece, noninvasive, and discreet BALCAP prosthesis proposed herein offers the potential to satisfy both requirements via a simple, adjustable or presized hat, available in different styles/colors. With the BALCAP prosthesis, low-amplitude vibrotactile cues are provided directly to the head via hatband tactors that furnish the wearer with feedback concerning head tilt in the pitch and roll planes, whether he/she is stationary or moving. To evaluate the utility of the proposed BALCAP balance prosthesis, patients with chronic balance dys- function spanning a range of etiologies (e.g., peripheral dysfunction, central dysfunction, and multi-factorial disequilibrium, also referred to as disequilibrium of aging) will undergo postural stability and gait assessments to determine if the device offers: (1) assistive benefit; i.e., significantly improves assessment scores when the BALCAP is enabled vs. disabled; and (2)rehabilitation benefit; i.e., yields significantly-improved assessment scores when the BALCAP is disabled (turned off) following 6 weeks of rehabilitation training with the device enabled. Regarding the first hypothesis, prior work by the proposing team demonstrated significant assistive improvements in postural stability in patients with bilateral vestibular loss (BVL) based on a first-generation head-mounted vibrotactile prosthesis. The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wider range of disease etiologies than was addressed in the prior study, the inclusion of which will greatly expand the size of the commercial market. Concerning the second hypothesis, published findings from one research group supports the notion that rehabilitation training using such a substitute sensory channel can lead to post-training retention of residual balance improvement. However, directly contradictory findings-at least concerning BVL patients-have been published by an independent group. To reconcile these disparate outcomes, the work proposed herein will also investigate the rehabilitative potential of the BALCAP device based on a 6-week structured training regimen that includes both static and dynamic exercises. If rehabilitative training to achieve residual balance retention is possible, expanding training to include both static and dynamic activities is most likely to make it evident. If the hypothesis concerning the assistive benefit is supported, a head-mounted vibrotactile prosthesis product would enable immediate benefit to be provided to a large number of patients with chronic postural instability. If rehabilitative training to achieve residual balance retention is possible, it would open new areas of research, such as how to optimize training to maximize residual retention of balance improvements. PUBLIC HEALTH RELEVANCE: Products resulting from this research are anticipated to offer significant benefit to patients with chronic postural instability to help them improve their balance in both static and dynamic activities, allowing them to function more normally. The availability of a simple, one-piece, noninvasive, discreet, and low-cost balance prosthesis will enhance the quality of life for balance-disordered patients and could lead to further advancements in this area. The use of such a device as an assistive aid, both inside and outside of the home, could yield both immediate (assistive) and longer-term (rehabilitation) benefits. An assistive prosthesis might also allow patients to "train" while performing their normal activities (in contrast to structured exercises), substantially reducing patient burden.