TheraBracelet: The first and only wearable to instantly improve stroke hand function

项目摘要：中风后手功能障碍非常普遍，严重限制功能和功能 独立。事实上，每40秒就会发生一次新的中风，中风被认为是导致中风的主要原因 长期残疾。然而，在家里，每天，在活动中，没有辅助设备来帮助手功能 日常生活。手开矫形器等现有设备价格昂贵(例如Myomo和Bioness 价格为7,500美元以上)，不舒服，笨重，适合在短期治疗期间使用，而不是 在日常生活中。因此，它们的影响是有限的。因此，发展有效而又负担得起的 辅助设备是最重要的。该提案通过提供 正在申请专利的创新技术。“TheraBraclet”是一个应用了难以察觉的白噪音的腕带。 震动到皮肤。TheraBraclet是有效的，因为它被证明可以立即改善慢性中风 初步研究中幸存者的触觉和手部灵巧性。TheraBraclet价格实惠，只需使用 一种低成本的振动器。TheraBraclet也是平移的，因为手腕上巧妙地放置了振动器 不会干扰手指的灵巧运动，而且只涉及皮肤上难以察觉的振动，风险很低。 这些实用性确保了在家庭环境中易于采用，从而对感觉运动障碍产生了较大影响。 商业化的关键下一步，也就是第一阶段提案的目标，是确定 在一个月的日常活动中，每天全天使用这种辅助设备的可行性和安全性，以及 确定TheraBraclet的即时效果在长期使用过程中是否持续。这一目标将是 采用双盲、随机、对照、交叉设计研究。可行性(合规性 每天使用该设备)和安全性(感觉、力量、灵巧、疼痛、痉挛、皮肤不会恶化 刺激性)将评估治疗条件与对照条件(佩戴设备 无振动)通过每周评估。其可行性和安全性可与佩戴 Watch和FDA批准的类似设备将支持TheraBraclet的商业可行性 必要的监管批准。此外，TheraBraclet在改善手功能方面的即时好处将是 每周评估一次。TheraBraclet在所有每周评估中持续获得即时收益将支持 耐用性(即在一个月以上的日常延长使用期间不会对振动脱敏)。 对可行性、安全性和耐用性的了解将为这部小说的商业化铺平道路 技术该项目预计将导致一种辅助腕带，可以在 日常生活活动，从而提高独立性和生活质量，并减轻照顾者的负担 大量中风幸存者手部受损。

Project Summary: Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. In fact, every 40 seconds a new stroke occurs, and stroke is recognized as the leading cause of long-term disability. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. Existing devices such as hand-opening orthoses are expensive (e.g. Myomo and Bioness are priced at $7,500+), uncomfortable, bulky, and meant for use during short therapy sessions as opposed to during daily living. Thus their impact is limited. Consequently, the development of efficacious and affordable assistive device is of paramount importance. This proposal addresses this critical gap by providing an innovative patent-pending technology. The “TheraBracelet” is a wristband applying imperceptible white-noise vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors’ touch sensation and hand dexterity in preliminary studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. The essential next step toward commercialization, thus the objective of this Phase I proposal, is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity, and to determine if TheraBracelet’s instant effects are sustained during prolonged use. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety (no worsening of sensation, strength, dexterity, pain, spasticity, skin irritation) will be assessed for the treatment condition compared to the control condition (wearing the device without vibration) through weekly evaluations. The feasibility and safety level comparable to those of wearing a watch and of a comparable FDA-approved device will support commercial viability of TheraBracelet with necessary regulatory approvals. In addition, TheraBracelet’s instant benefits in improving hand function will be assessed weekly. Persistence of TheraBracelet’s instant benefits across all weekly evaluations will support durability (i.e. desensitization to vibration does not occur during extended daily use over a one-month period). The knowledge of feasibility, safety, and durability will pave the way toward commercialization of this novel technology. This project is expected to lead to an assistive wristband that increases hand function during activities of daily living, thus increasing independence and quality of life and reducing caregiver burden for a large number of stroke survivors with hand impairment.