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.

失去一只胳膊使他们更难工作，更难参加休闲活动，也更难完成独立生活所需的许多任务。使用假臂(假肢)可以帮助这些活动，许多研究已经进入设计先进的假肢，可以取代许多功能的完整的手和手臂。然而，假肢通常是使用插座连接到身体上的，插座适合安装在残肢上。插座可能会引起皮肤刺激问题，长时间佩戴可能会感到不舒服或热。解决这个问题的一种方法是将假体直接连接到残肢的骨头上。这解决了与佩戴插座相关的问题，允许更广泛的运动范围，使假体感觉更像用户身体的一部分。假体连接到一根金属棒上，在两步手术中插入手臂骨中。然后，骨头长成金属棒，形成一种牢固的永久连接。这个过程被称为骨整合(OI)。另一个问题是如何控制假肢，即如何让它做用户想让它做的事情。一些假肢是通过肌肉收缩时产生的微小电信号(称为肌电信号)来控制的。肌电信号通常由放置在肌肉上的皮肤上的电极记录下来；这些信号由计算机算法解码，并转化为假肢的控制信号。从皮肤表面记录的肌电信号可能不可靠，因此另一种选择是将电极植入肌肉。一种名为OPRA(OPRA)的系统使用OI连接假体。该系统的一个新版本，e-OPRA，使用植入电极的OI。E-OPRA还可以用来刺激周围神经，以便用户感受到假体的一些感觉反馈，这也可能有助于对设备的控制。我们的目标是进行两个临床试验，首先测试e-OPRA是否比OPRA提供更好的功能和舒适性，其次确定e-OPRA在有或没有感觉反馈的情况下更好。我们的基本原理是，与使用插座相比，直接将假体连接到骨骼上有许多优势，植入的电极将比皮肤表面的电极提供更干净、更稳定和更可靠的肌电信号，感觉反馈将帮助用户控制他们的设备。因此，我们期望具有感觉反馈的e-OPRA系统将比传统的基于插座的系统或没有感觉反馈的OI系统提供更好的假体控制和功能。