Adaptive High Intensity Electrical Stimulation for Post-Surgical Rehabilitation

描述（由申请方提供）：术后膝关节固定后股四头肌肌力的恢复是一个重要的治疗目标，与步态质量和日常生活活动能力相关。来自不同研究小组的几项研究表明，神经肌肉电刺激（NMES）与全面的术后康复计划结合使用，是实现股四头肌强化的安全有效的方法。使用高强度NMES技术已经证明了最深刻的结果，在该技术中，在患者坐在生物力学测力计上的物理治疗期间，每周进行几次股四头肌的非常强烈的等长收缩。该技术的有效性已被证明适用于前交叉韧带（ACLR）手术重建后接受康复的个人;然而，该技术的广泛临床接受程度有限。我们断言，这种高强度电刺激技术将得到更广泛的实践：1）如果低成本，实用，有凝聚力的系统可用于取代昂贵的和松散连接的基于研究的设备，以及2）如果该系统涉及NMES单元，该NMES单元使用基于结果的范例自动控制刺激，而不需要治疗师的不断参与。我们提出了一种新的康复系统，适用于术后膝关节固定期间的股四头肌强化，其中膝关节将使用仪器化术后膝关节支架进行稳定，刺激由具有自主自适应刺激控制能力的高输出便携式NMES单元提供。该器械的目标市场是为ACLR或全膝关节置换术（TKA）后接受康复治疗的患者提供服务的诊所。该系统的目标价格为4000美元。因此，该FastTrack SBIR项目的目标是使用基于实验室的设备证明第I阶段自适应刺激控制方法的可行性。我们将接口我们的自适应刺激器的KinCom测力计，并表明，刺激器可以引起足够的强度，功能的结果可以预期的收缩，并证明自适应控制器可以开发适当的刺激模式，用于在这个低周期计数的应用。第二阶段的目标将是：1）开发一种能够在接近最大等长收缩期间稳定膝盖并获得所得扭矩的测量值的仪器化膝盖支架; 2）实现我们的自适应刺激控制器的快速训练版本，其适用于这种低循环计数应用; 3）实现可能对某些用户更舒适的替代基本刺激波形;以及4）证明所提出的系统在ACLR或TKA后用于股四头肌增强的有效性。/相关性拟议的工作可能有益于公众健康，通过开发一种电刺激锻炼设备，适用于前交叉韧带（ACLR）或全膝关节置换术（TKA）手术修复后固定期间的股四头肌加强。股四头肌加强已被证明可以改善步态和改善日常生活活动（ADL）的表现。美国每年约有100，000例ACLR和400，000例TKA手术。

DESCRIPTION (provided by applicant): Recovery of quadriceps muscle force following post-surgical knee immobilization is a significant therapeutic aim which is associated with quality of gait and the ability to perform activities of daily living. Several studies from various research groups have shown that neuromuscular electrical stimulation (NMES), used in conjunction with a comprehensive post-surgical rehabilitation program, is a safe and highly effective method for achieving quadriceps strengthening. The most profound results have been demonstrated with use of high intensity NMES technique in which a few very strong isometric contractions of the quadriceps muscle were performed several times per week during a physical therapy session in which the patient was seated on a biomechanical dynamometer. Efficacy of this technique has been demonstrated for individuals undergoing rehabilitation following surgical reconstruction of the anterior cruciate ligament (ACLR); however, widespread clinical acceptance of the technique has been limited. We assert that this high intensity electrical stimulation technique would be more widely practiced: 1) if a low cost, practical, cohesive system were available to replace costly and loosely connected research-based apparatus, and 2) if the system involved an NMES unit that controlled stimulation automatically using an outcome-based paradigm that did not require incessant involvement of the therapist. We propose a novel rehabilitation system indicated for quadriceps strengthening during post-surgical knee immobilization in which the knee joint will be stabilized using an instrumented post-surgical knee brace and stimulation is delivered by a high output, portable NMES unit with autonomous, adaptive stimulation control capabilities. The target markets for this device would be clinics who serve patients undergoing rehabilitation following ACLR or total knee arthroplasty (TKA). The target price for the system will be $4000. The goals of this FastTrack SBIR project are therefore to demonstrate feasibility of the adaptive stimulation control approach in Phase I using laboratory-based apparatus. We will interface our adaptive stimulator to the KinCom dynamometer and show that the stimulator can elicit a contraction of sufficient strength that function outcomes could be expected, and demonstrate that the adaptive controller can develop appropriate stimulation patterns for use in this low-cycle count application. The Phase II goals will be: 1) to develop an instrumented knee brace capable of stabilizing the knee during near maximal isometric contractions and obtaining measurements of the resulting torque; 2) to implement a rapid training version of our adaptive stimulation controller that is suited for use in this low cycle count application; 3) to implement an alternate fundamental stimulation waveform that may be more comfortable to some users; and 4) to demonstrate efficacy of the proposed system for quadriceps strengthening following ACLR or TKA. / Relevance The proposed work may benefit public health through development of an electrical stimulation exercise device indicated for quadriceps strengthening during post-surgical immobilization following surgical repair of the anterior cruciate ligament (ACLR) or total knee arthroplasty (TKA). Quadriceps strengthening has been shown to improve gait and improve performance of activities of daily living (ADLs). There are approximately 100,000 ACLR and 400,000 TKA surgeries per year in the United States.