Stimulation-Augmented Exercise and Neuromotor Therapy

描述（由申请人提供）：本阶段II SBIR项目拟为不完全性脊髓损伤（iSCI）患者开发一种电刺激增强运动器械。 该器械将提供一种闭合链、承重下肢运动，有可能调节肌肉并逆转或减缓骨矿物质密度的损失速率。 将鼓励用户自愿进行练习。 客户意志力将通过电刺激和电驱动器增强，以便在每个运动周期中完成规定的运动范围。 自适应刺激控制器将基于运动误差和运动活动连续地调整刺激曲线，以仅提供完成锻炼所必需的刺激，同时鼓励客户在每个锻炼周期上贡献他们最大的意志努力。 将开发一个视觉反馈基础设施，鼓励客户参与，强调临床相关的治疗锻炼目标，并奖励客户的成就。 视觉环境将要求客户端生成一系列适当定时和执行的意志触发事件（范围从“施加力的跟踪水平”到“无辅助运动”），这些事件将获得全方位的运动循环和游戏中的成功。 我们假设，在综合运动康复计划中长期使用该器械，除了运动的局部和全身受益外，还可能导致功能改善。 实现了I期可行性里程碑，包括证明：1）客户意志努力可以与刺激控制器同步; 2）在皮肤感觉完整的人群中，功能刺激水平可以良好耐受（潜在过敏）;和3）刺激控制器可以适应客户的意志努力，运动 我们建议通过以下第二阶段目标来建立第一阶段的结果：1）开发一种能够提高运动质量的触觉驱动器，提供更大范围和更好的体重负荷控制，允许最需要运动的晚期骨质疏松症患者使用，并通过触觉反馈而不是实时视觉显示来实现协调意志和刺激增强努力的目标; 2）开发智力上吸引人的视觉显示环境，鼓励和奖励临床相关的客户意志努力;以及3）提高可靠性和可制造性。 我们将通过一项两中心临床试验证明其有效性，在该试验中，20名慢性不完全性脊髓损伤患者使用该器械参加了为期12周的运动模式。结果指标将包括功能改善的评估（即，步态分析）和测力计测试，以评估独立于运动相关的扭矩产生能力的改善的意志控制的改善。该设备的目标市场是为患有神经运动障碍的个人提供服务的诊所，如不完全SCI，创伤性脑损伤或中风。 该设备将在基于电刺激的运动设备市场中具有竞争力的价格。 公共卫生救济：拟议的工作可能有利于公众健康，通过开发一个临床上可行的，电刺激为基础的治疗运动设备用于运动康复脊髓损伤或中风。与现有的设备和技术相比，自适应控制的电刺激、电刺激辅助和视频游戏组件以及仪器、控制、刺激、可视化和报告特征的紧密集成可以提高治疗干预对许多受影响个体的功效和可用性。

DESCRIPTION (provided by applicant): This Phase II SBIR project proposes to develop an electrical stimulation augmented exercise device for individuals with incomplete spinal cord injury (iSCI). The device will provide a closed-chain, load bearing lower extremity exercise that has the potential to condition muscles and reverse or slow the rate of loss of bone mineral density. Users will be encouraged to voluntarily perform the exercise. Client volitional efforts will be augmented by electrical stimulation and a servomotor drive such that the prescribed exercise range of motion is fulfilled with each movement cycle. The adaptive stimulation controller will continuously adjust the stimulation profile based on movement errors and servomotor activity to provide only the stimulation that is necessary to complete the exercise while encouraging clients to contribute their best volitional effort on each exercise cycle. A visual feedback infrastructure will be developed that encourages client participation, emphasizes clinically relevant therapeutic exercise goals, and rewards client achievements. The visual environment will require clients to generate a series of appropriately timed and executed volitional trigger events (ranging from 'trace levels of applied force' to 'unassisted movements') which will be rewarded with a full range of motion movement cycle and success in a game. We hypothesize that long-term use of the device in a comprehensive motor rehabilitation program may lead to functional improvements in addition to the localized and systemic benefits of exercise. Phase I feasibility milestones were achieved, including demonstration that: 1) client volitional effort could be synchronized with the stimulation controller; 2) functional stimulation levels could be well tolerated in this population where cutaneous sensation is in-tact (potentially hypersensitive); and 3) the stimulation controller could accommodate client volitional effort and generate only the stimulation that was needed to elicit the desired exercise movement. We propose to build upon Phase I results through the following Phase II aims: 1) develop a servomotor drive that will improve exercise quality, provide a wider range and better control of bodyweight loading, allow use by individuals with advanced osteoporosis who are most in need of the exercise, and accomplish the goal of coordinating volitional and stimulation-augmented efforts via haptic feedback rather than a real-time visual display; 2) develop intellectually engaging visual display environments that encourage and reward clinically relevant client volitional efforts; and 3) improve reliability and manufacturability. We will demonstrate efficacy via a two-site clinical trial in which twenty (20) individuals with chronic incomplete spinal cord injury participate in a 12-week exercise paradigm using the device. Outcome measures will include assessment of functional improvements (i.e., FIM, gait analysis) and a dynamometer test to assess improvements in volitional control independent of exercise-related improvements in torque generating capability. The target market for the device is clinics who serve individuals with neuromotor disabilities such as incomplete SCI, traumatic brain injury, or stroke. The device will be competitively priced within the electrical stimulation-based exercise equipment market. PUBLIC HEALTH RELEVENCE: The proposed work may benefit public health through development of a clinically viable, electrical stimulation based therapeutic exercise device for use in motor rehabilitation following spinal cord injury or stroke. Compared to existing devices and techniques, the adaptively controlled electrical stimulation, servomotor assist, and video game components and tight integration of instrumentation, control, stimulation, visualization, and reporting features may improve efficacy and availability of the therapeutic intervention for many affected individuals.