A Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study

仿生手臂的神经肌肉骨骼接口：随机交叉研究

• 批准号: 10577128
• 负责人: Levi John Hargrove
• 金额: $ 120.56万
• 依托单位: REHABILITATION INSTITUTE OF CHICAGO D/B/A SHIRLEY RYAN ABILITYLAB
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10577128
• 关键词: Amputation; Amputees; Arm Bones; Artificial Arm; Bionics; Calibration; Clinical; Clinical Trials; Computational algorithm; Contracts; Cross-Over Studies; Data; Devices; Electrodes; Electromyography; Electronics; Hand; Home; Implant; Implanted Electrodes; Individual; Lead; Leisure Activities; Life; Maps; Metals; Movement; Muscle; Myoelectric prosthesis; Noise; Operative Surgical Procedures; Osseointegration; Outcome Measure; Patients; Pattern Recognition; Peripheral Nerve Stimulation; Persons; Phase; Positioning Attribute; Process; Prosthesis; Prosthetic rehabilitation; Protocols documentation; Random Allocation; Randomized; Research; Research Design; Residual state; Rod; Safety; Secure; Series; Signal Transduction; Skeleton; Skin; Surface; Suspensions; Sweden; System; Technology; Testing; Training; Upper Extremity; Work; arm; bone; design; efficacy validation; first-in-human; functional improvement; healing; implantation; improved; innovation; muscle reinnervation; neuromusculoskeletal; osseointegrated implant; prospective; prosthesis control; reinnervation; residual limb; sensor; sensory feedback; skin irritation; somatosensory

Loss of an arm makes it harder to work, to take part in leisure activities, and to do many of the tasks needed to lead an independent life. Using an artificial arm (prosthesis) can help with these activities, and a lot of research has gone into designing advanced prostheses that can replace the many functions of an intact hand and arm. However, a prosthesis is typically attached to the body using a socket, which fits over the residual limb. Sockets can cause problems with skin irritation and can be uncomfortable or hot to wear for long periods. One way around this is to attach the prosthesis directly to the bone of the residual limb. This solves the problems associated with wearing a socket, allows a wider range of movement, and the makes the prosthesis feel more like a part of the user’s body. The prosthesis is attached to a metal rod that is inserted into the arm bone during a two-step surgery. The bone then grows into the metal rod, forming a strong permanent attachment. This process is called osseointegration (OI). Another problem is how to control the prosthesis, i.e., how to make it do what the user wants it to do. Some prostheses are controlled using small electrical signals (called EMG signals) that are produced by muscles when they contract. EMG signals are usually recorded by electrodes placed on the skin over the muscle; the signals are decoded by a computer algorithm and turned into control signals for the prosthesis. EMG signals recorded from the skin surface can be unreliable, so another option is to implant the electrodes onto the muscle. A system called Osseointegration of Prostheses for the Rehabilitation of Amputees (OPRA) uses OI to attach the prosthesis. A new version of this system, e-OPRA, uses OI with implanted electrodes. e-OPRA can also be used to stimulate peripheral nerves so that the user feels some sensory feedback from the prosthesis, which also may help with control of the device. Our objective is to perform two clinical trials to first test whether e-OPRA provides better function and comfort than OPRA, and second to find out whether e-OPRA is better with or without sensory feedback. Our rationale is that directly attaching the prosthesis to the skeleton has many advantages over use of a socket, that implanted electrodes will provide cleaner, more stable and reliable EMG signals than electrodes at the skin surface, and that sensory feedback will help the user control their device. We therefore expect that the e-OPRA system with sensory feedback will provide improved prosthesis control and function compared to conventional socket-based systems or OI without sensory feedback.

失去一只手臂会使人们更难工作，更难参加休闲活动，更难完成许多独立生活所需的任务。使用人工手臂（假肢）可以帮助这些活动，并且已经进行了大量的研究来设计先进的假肢，可以取代完整的手和手臂的许多功能。然而，假肢通常使用插座连接到身体上，该插座安装在残肢上。插座可能会导致皮肤刺激问题，长时间佩戴会感到不舒服或发热。解决这个问题的一种方法是将假肢直接连接到残肢的骨头上。这解决了与佩戴承窝相关的问题，允许更大范围的运动，并且使假肢感觉更像使用者身体的一部分。假体连接到一个金属杆，在两步手术过程中插入臂骨。然后骨头长入金属棒，形成牢固的永久附着。这个过程被称为骨整合（OI）。另一个问题是如何控制假体，即，如何让它做用户想让它做的事情。一些假肢是使用肌肉收缩时产生的小电信号（称为EMG信号）来控制的。EMG信号通常由放置在肌肉皮肤上的电极记录;信号由计算机算法解码并转化为假肢的控制信号。从皮肤表面记录的EMG信号可能不可靠，因此另一种选择是将电极植入肌肉上。一种称为截肢者康复假体骨整合（OPRA）的系统使用OI连接假体。该系统的新版本e-OPRA使用带有植入电极的OI。e-OPRA还可用于刺激外周神经，使得用户感觉到来自假体的一些感觉反馈，这也可有助于控制装置。我们的目标是进行两项临床试验，首先测试e-OPRA是否比OPRA提供更好的功能和舒适度，其次确定e-OPRA是否有或没有感觉反馈。我们的基本原理是，直接将假肢连接到骨骼上比使用插座有许多优点，植入电极将提供比皮肤表面电极更干净，更稳定和可靠的EMG信号，感觉反馈将帮助用户控制他们的设备。因此，我们预计，与传统的基于插座的系统或没有感觉反馈的OI相比，具有感觉反馈的e-OPRA系统将提供改进的假肢控制和功能。