Adaptive High Intensity Electrical Stimulation for Post-Surgical Rehabilitation

描述(申请人提供)：膝关节手术后制动后股四头肌肌力的恢复是一个重要的治疗目标，它与步态质量和日常生活活动的能力有关。来自不同研究小组的多项研究表明，神经肌肉电刺激(NMES)与全面的术后康复计划相结合，是实现股四头肌加强的一种安全和高效的方法。最深刻的结果是使用高强度的NMES技术，在患者坐在生物力学测力仪上的物理治疗过程中，每周进行几次非常强烈的股四头肌等长收缩。这项技术的有效性已经在前交叉韧带(ACLR)手术重建后接受康复治疗的患者中得到证实；然而，该技术在临床上的广泛接受度有限。我们断言，这种高强度电刺激技术将得到更广泛的实践：1)如果有低成本、实用、有凝聚力的系统来取代昂贵且连接松散的基于研究的设备，以及2)如果系统包括NMES单元，该单元使用基于结果的范式自动控制刺激，而不需要治疗师的持续参与。我们提出了一种新的康复系统，用于在手术后膝关节制动期间加强股四头肌，其中膝关节将使用手术后仪器化的膝关节支架稳定，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。该设备的目标市场将是为接受ACLR或全膝关节置换术(TKA)后康复的患者提供服务的诊所。该系统的目标价格将为4000美元。因此，FastTrack SBIR项目的目标是使用基于实验室的设备在第一阶段证明自适应刺激控制方法的可行性。我们将把我们的自适应刺激器连接到KinCom测功机上，并展示刺激器可以引起足够强度的收缩，使功能结果可以预期，并证明自适应控制器可以开发出适合在这种低周期计数应用中使用的刺激模式。第二阶段的目标将是：1)开发一种仪表式膝关节支架，能够在接近最大等长收缩时稳定膝关节，并获得所产生的扭矩的测量结果；2)实现我们的自适应刺激控制器的快速训练版本，适合在这种低循环计数应用中使用；3)实现可能对一些用户更舒适的替代基本刺激波形；以及4)展示所建议的系统在ACLR或TKA后加强股四头肌的有效性。建议的工作可能有益于公众健康，方法是开发一种电刺激锻炼装置，用于在手术修复前十字韧带(ACLR)或全膝关节置换术(TKA)后的术后制动期间加强股四头肌。增强股四头肌已被证明可以改善步态，改善日常生活能力(ADLS)。在美国，每年大约有10万例ACLR和40万例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.