Adaptive High Intensity Electrical Stimulation for Post-Surgical Rehabilitation

用于术后康复的自适应高强度电刺激

• 批准号: 7615130
• 负责人: Eric C Hartman
• 金额: $ 36.86万
• 依托单位: CUSTOMKYNETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-15 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7615130
• 关键词: Activities of Daily Living; Algorithms; Biomechanics; Braces-Orthopedic appliances; Client; Clinic; Clinical; Databases; Degenerative polyarthritis; Delaware; Development; Devices; Electric Stimulation; Exercise; Gait; Goals; Immobilization; Individual; Isometric Contraction; Isometric Exercise; Knee; Knee joint; Laboratories; Lead; Leg; Marketing; Measurement; Methods; Muscle; Operative Surgical Procedures; Outcome; Output; Patients; Pattern; Performance; Phase; Physical therapy; Pilot Projects; Postoperative Period; Price; Protocols documentation; Public Health; Ramp; Recovery; Recruitment Activity; Regulation; Rehabilitation therapy; Reporting; Research; Safety; Signal Transduction; Small Business Innovation Research Grant; Speed; Staging; System; Techniques; Therapeutic; Time; Torque; Training; Transducers; United States; Universities; Work; analog; anterior cruciate ligament reconstruction; base; cost; improved; instrument; knee replacement arthroplasty; neuromuscular; novel; programs; prototype; tool

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.

描述（由申请人提供）：手术后膝盖固定后的股四头肌肌肉力量是一个重要的治疗目的，与步态质量和进行日常生活活动的能力有关。来自各个研究小组的几项研究表明，与全面的手术后康复计划结合使用的神经肌肉电刺激（NME）是一种安全有效的方法，可实现股四头肌增强。使用高强度NMES技术证明了最深刻的结果，其中在物理治疗课程中，每周进行了几次非常强的股四头肌等均值收缩，其中患者坐在生物力学测功机上。该技术的功效已被证明是在前交叉韧带（ACLR）手术重建后接受康复的个体的表现。但是，该技术的广泛临床接受是有限的。我们断言，这种高强度的电刺激技术将得到更广泛的实践：1）如果可使用低成本，实用，凝聚力的系统来替换成本昂贵且基于较松散的基于研究的设备，并且2）如果系统涉及的NMES单元可以自动使用基于结果的刺激来控制刺激的刺激，则不需要刺激性的态度，而不需要刺激性地参与更具影响力的刺激。我们提出了一个新型的康复系统，该系统指示在手术后的膝盖固定过程中加强股四头肌，在该系统中，使用仪器的手术后的膝盖支架可以稳定膝关节，并由高输出，便携式NMES单位具有自主，适应性刺激控制能力。该设备的目标市场将是为ACLR或总膝关节置换术（TKA）接受康复的患者提供服务的诊所。该系统的目标价格为4000美元。因此，这个FastTrack SBIR项目的目标是证明使用基于实验室的设备在I期中自适应刺激控制方法的可行性。我们将使我们的自适应刺激器与Kincom测功机连接在一起，并表明刺激器可以引起足够强度的收缩，可以预期功能结果，并证明自适应控制器可以开发适当的刺激模式，以在此低循环计数中使用。 II期目标将是：1）开发一个仪器的膝盖支架，能够在近乎最大的等距收缩期间稳定膝盖并获得所得扭矩的测量； 2）实施适用于此低周期计数应用程序的自适应刺激控制器的快速培训版本； 3）实施对某些用户可能更舒适的替代基本刺激波形； 4）证明所提出的系统在ACLR或TKA后加强股四头肌的功效。 /相关性拟议的工作可能通过开发用于在手术后固定过程中加强股四头肌的电刺激运动装置来使公共卫生受益，而前交叉韧带（ACLR）或总膝关节置换术（TKA）进行手术修复后手术后固定。股四头肌的加强已被证明可以改善步态并改善日常生活活动（ADL）的表现。在美国，每年约有100,000个ACLR和40万TKA手术。