Use of a Powered Orthotic Exoskeleton to Promote Mobility Through Improved Squat, Knee Flexion and Loading of the Paretic Leg in Persons with Chronic Stroke

使用动力矫形外骨骼通过改善慢性中风患者的下蹲、膝关节屈曲和瘫痪腿的负重来促进活动能力

• 批准号: 10155112
• 负责人: Ann Michele Spungen
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10155112
• 关键词: Activities of Daily Living; Affect; Articular Range of Motion; Biomechanics; Body Composition; Bone Density; Cardiovascular Deconditioning; Cardiovascular Physiology; Carpet; Clinical Trials; Clothing; Communities; Competence; Control Groups; Development; Devices; Educational Intervention; Energy Metabolism; Environment; FDA approved; Future; Gait; Health; Hip Joint; Hip region structure; Home; Hour; Impairment; Intervention; Intuition; Investigation; Joints; Knee; Knee joint; Lead; Learning; Leg; Limb structure; Lower Extremity; Measurement; Measures; Metabolic; Monitor; Motivation; Motor; Movement; Orthotic Devices; Outcome; Outcome Measure; Oxygen Consumption; Paresis; Participant; Patients; Persons; Phase; Pilot Projects; Quality of life; Randomized; Rehabilitation Centers; Rehabilitation therapy; Research; Rotation; SF-36; Secondary to; Spinal cord injury; Stroke; Structure; System; Testing; Time; Training; Training Programs; Transferable Skills; Veterans; Visit; Volition; Walking; Weight; Work; chronic stroke; clinically significant; community setting; cost; exoskeleton; foot; gait rehabilitation; improved; improved functioning; improved mobility; instrument; joint mobilization; leg paresis; medical complication; muscle form; muscle strength; novel; portability; post stroke; powered exoskeleton; pressure; recruit; reduced muscle strength; stroke survivor; wearable device

Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices approved by the FDA for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement. This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide. The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb will be accomplished using an instrumented goniometer; changes in limb loading will be monitored using a foot pressure mapping system; and stepping parameters will be recorded using the GaitRite carpet. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton will be assessed from a 6-minute walking test using a portable metabolic cart. Additional exploratory outcome measures of QOL will be determined using the SF-36 and the Stroke Specific Quality of Life Scale. Baseline testing for both groups will be performed while ambulating without the device and prior to starting in the training program. The exoskeleton group will repeat testing within the first 3 sessions of the training program. Post assessments will be obtained after 36 sessions of training. Retention will be assessed by repeating the assessments without the exoskeleton after 1 month of stopping the training program. It is anticipated that longitudinal training with the device will increase number of squats achievable, increase knee flexion during swing, increase loading of the paretic limb, and induce symmetrical stepping. No immediate effect on energy expenditure by the device is expected however, a training effect is expected to demonstrate improvement in the energy cost of ambulation. Any gains observed during this study may not be retained, but as this device has the potential to be used in the home and community environment, justifying a prescription of this device for retention purposes may be warranted. Use of this device may also lead to improvement of QOL.

90%的中风幸存者在临床上有明显的步态障碍，导致继发性 医疗并发症，包括心血管疾病解除和生活质量(QOL)降低。几个 提高活动量和流动性的康复干预措施已被证明是有益的。 这些运动步态训练干预措施中的大多数带来的挑战需要反复访问 康复中心。新型动力外骨骼的最新发展提供了一种潜在的机制 中风幸存者，以改善家庭和社区的流动性。尽管主要研究使用的是 这些装置已经在脊髓损伤患者身上使用，目前有两种装置获得FDA批准 用于中风患者，正在开发更多的设备。Keeogo动力矫形器 外骨骼是一种专为中风患者设计的新型设备，这些患者可以行走，但步态受损。这 该装置由一个脊状矫形结构组成，放置在腿上的衣服上，电池为马达提供动力。 这有助于双膝的步态运动。该系统监控用户驱动的臀部运动，并解释 这一动作要在膝关节处施加适当的辅助。这种独特的方法使学习 直观，使用户只能适应系统，而不是学习如何控制设备以 启动所需的移动。 这项建议是一项随机对照的先导研究。15名患有慢性中风的退伍军人(&gt；6个月) 那些保留了一些采取措施的能力，但步态受损的人将被招募。十名参与者将是 随机分为外骨骼组5只，对照组5只。两个小组都将被要求完成36 一小时的步行训练。外骨骼小组将使用Keeogo动力矫形器进行训练 外骨骼和对照组将在不使用自己的常规助手的情况下进行训练。 主要目的是确定使用这种外骨骼进行训练的效果及其改善能力。 根据五次坐立测试的评估，转为站立和坐着。次要目标将是评估 该装置在地面行走过程中的影响。调查膝关节活动范围变化的结果测量 偏瘫肢体的运动和负荷的变化将使用仪表式测角仪完成； 肢体负荷将使用足部压力测绘系统进行监测；并将记录步态参数 使用GaitRite地毯。人与人步行过程中能量消耗变化的探讨 在没有动力的情况下，外骨骼将通过使用便携式代谢车进行的6分钟步行测试进行评估。 生活质量的其他探索性结果测量将使用SF-36和卒中特定量表来确定 生活质量量表。 两组的基线测试将在不使用该设备的情况下行走时以及在 从培训计划开始。外骨骼小组将在前3次会议中重复测试 培训计划。将在36期培训后进行员额评估。留任将通过以下方式进行评估 在停止训练1个月后，在没有外骨骼的情况下重复评估。 预计使用该装置进行的纵向训练将增加可实现的下蹲次数， 在摆动过程中增加膝关节屈曲，增加瘫痪肢体的负荷，并诱导对称步法。不是 然而，预计该设备对能量消耗的即时影响，预计将产生训练效果 证明步行的能源成本有所改善。在这项研究中观察到的任何收益可能不是 保留，但由于该设备有可能在家庭和社区环境中使用，因此有理由 出于保留目的而开此装置的处方可能是合理的。使用此设备还可能导致 生活质量的改善。