Adaptive Stimulator for Exercise and Rehabilitation

描述(申请人提供)：我们建议开发一种具有运动和康复适应能力的电刺激系统。目标人群为：1)有完整或不完全脊髓损伤的个人，有兴趣通过电刺激的下肢运动改善身体健康的；2)有完全或不完全脊髓损伤的个人，寻求发展或保持足够的肌肉力量，以便能够常规地使用FES系统站立；以及3)有不完全脊髓损伤、脑损伤或中风的个人，有可能通过运动再训练疗法恢复自愿的下肢运动功能。 拟议的便携式运动单元将包括传感器和自适应控制算法，以提供可重复的运动。我们预计，自适应控制器将提供安全和有效的运动，并且自适应控制器将允许在运动中定义运动目标，而不是特定于刺激的参数。对于运动再培训，该系统将通过只提供必要的刺激来补充使用者的努力，从而鼓励最大限度的自愿努力。 第一阶段目标顺利实现。第一阶段的结果清楚地证明了我们方法的可行性，并为拟议的第二阶段工作奠定了坚实的基础。 在第二阶段，我们将：1)开发传感器来提供直接的膝关节角度测量并简化穿戴和校准，2)开发一个原型自适应刺激器，供患有完全性或不完全性脊髓损伤的个人使用，3)开发一个临床软件套件，用于方案编程、性能评估和文档记录，4)在一项涉及希望通过基于长期电刺激的训练方案来增加肌肉质量、力量和耐力的研究中，评估该装置的有效性。以及5)在一项研究中评估该装置的有效性，该研究涉及对目标肌肉具有一定程度的自愿控制并且希望改善肌肉状况并潜在地提高其执行功能性自愿活动的能力的不完全损伤的个人。

DESCRIPTION (provided by applicant): We propose to develop an electrical stimulation system with adaptive capabilities for exercise and rehabilitation. The target populations are: 1) individuals with complete or incomplete SCI who are interested in improving their physical fitness through electrically stimulated lower-extremity exercise, 2) individuals with complete or incomplete SCI who seek to develop or maintain adequate muscle strength to allow routine use of an FES system for standing, and 3) individuals with incomplete spinal cord injury, brain injury, or stroke who have the potential to regain voluntary lower extremity motor function through motor retraining therapy. The proposed portable exercise unit will include sensors and an adaptive control algorithm to provide repeatable movements. We anticipate that the adaptive controller will provide safe and effective exercise and that the adaptive controller will allow the exercise goals to be defined in movement rather than stimulation-specific parameters. For motor retraining, the system will encourage maximum voluntary effort by providing only the stimulation required to supplement the user's effort. The Phase I aims were achieved successfully. Phase I results clearly demonstrate the feasibility of our approach and have laid a strong foundation for the proposed Phase II effort. In Phase II, we will: 1) develop sensors to provide direct knee angle measurements and simplify donning and calibration, 2) develop a prototype adaptive stimulator for use by individuals with complete or incomplete SCI, 3) develop a clinical software suite for protocol programming, performance evaluation, and documentation, 4) assess the efficacy of the device in a study involving individuals with complete injuries who wish to increase muscle mass, strength and endurance through a long-term electrical stimulation based training protocol, and 5) assess the efficacy of the device in a study involving individuals with incomplete injuries who have some degree of voluntary control over the target muscles and who wish to improve muscle condition and potentially improve their ability to perform functional voluntary activities.