Stimulation-Augmented Exercise and Neuromotor Therapy

描述（由申请人提供）：本二期SBIR项目旨在为不完全性脊髓损伤（iSCI）患者开发一种电刺激增强运动装置。该设备将提供一个封闭链，承重的下肢运动，有可能调节肌肉，逆转或减缓骨密度损失的速度。我们将鼓励用户自愿执行此操作。病人意志的努力将通过电刺激和伺服电机驱动来增强，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根据运动误差和伺服运动活动不断调整刺激轮廓，只提供完成锻炼所需的刺激，同时鼓励客户在每个锻炼周期中贡献他们最好的意志努力。将建立视觉反馈基础设施，鼓励客户参与，强调临床相关的治疗运动目标，并奖励客户的成就。视觉环境将要求客户生成一系列适当的时间和执行的意志触发事件（从“施加力量的痕迹水平”到“无辅助的运动”），这将奖励一个完整的运动周期和游戏中的成功。我们假设，在全面的运动康复计划中长期使用该装置除了局部和全身的运动益处外，还可能导致功能改善。实现了第一阶段可行性里程碑，包括证明：1)客户的意志努力可以与增产控制器同步；2)在皮肤感觉正常的人群（潜在的过敏）中，功能性刺激水平可以很好地耐受；3)刺激控制器能够适应病人的意志努力，只产生引起期望运动动作所需的刺激。我们建议在第一阶段的结果基础上，通过以下第二阶段的目标：1)开发一种伺服电机驱动器，它将提高运动质量，提供更大范围和更好的体重负荷控制，允许最需要锻炼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)开发具有智力吸引力的视觉展示环境，鼓励和奖励临床相关的客户意志努力；3)提高可靠性和可制造性。我们将通过一项两站临床试验来证明其有效性，在该试验中，20名慢性不完全性脊髓损伤患者使用该装置进行为期12周的锻炼。结果测量将包括评估功能改善（即FIM，步态分析）和一个测力计测试，以评估独立于运动相关的扭矩产生能力改善的意志控制改善。该设备的目标市场是为神经运动障碍患者（如不完全性脊髓损伤、创伤性脑损伤或中风）提供服务的诊所。该设备的价格将在电刺激运动设备市场中具有竞争力。公共卫生相关性：通过开发一种临床可行的、基于电刺激的治疗性运动装置，用于脊髓损伤或中风后的运动康复，拟议的工作可能有益于公共卫生。与现有的设备和技术相比，自适应控制的电刺激、伺服运动辅助和视频游戏组件以及仪器、控制、刺激、可视化和报告功能的紧密集成可能会提高许多受影响个体的治疗干预的有效性和可用性。

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.