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: 10631850
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10631850
• 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.

百分之九十的中风幸存者具有临床意义的步态障碍 医疗并发症，包括心血管调节和减少生活质量（QOL）。一些 增加了活动水平和活动能力的康复干预措施已被证明是有益的。 大多数这些运动步态训练干预措施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 中风幸存者可以改善家庭和社区的流动性。尽管主要研究 这些设备已经患有脊髓损伤，目前有两种由FDA批准的设备 用于中风患者和其他设备的使用。 Keeogo动力矫形器 外骨骼是一种新型装置，适用于中风的人可以行走但步态障碍的人。这 设备由腿部矫形器结构和电池电池放在腿上的矫形器结构和电动机 这有助于步态运动。系统监视用户驱动并解释的髋关节运动 这种运动在膝盖关节上应用适当的援助。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 启动所需的运动。 该提案是一项随机对照的试点研究。十五名老兵慢性中风（> 6个月） 谁保留一些步骤但步态受损的能力将被招募。十个参与者将 随机分为外骨骼组，将5随机分为对照组。两组将被要求完成36 一小时的移动培训课程。外骨骼组将使用Keeogo动力矫形器训练 外骨骼和对照组将不使用自己的常规助手进行训练。 主要目的是通过这种外骨骼及其改善能力来确定训练的功效 通过五次坐下测试评估，转移到站立和坐着。第二个目标是评估 在地面行驶期间设备的影响。结果测量以研究膝盖范围的变化 将使用仪器的性角度计实现运动和肢体的载荷；变更 将使用脚压力映射系统监视肢体负荷；并记录阶梯参数 使用步枪地毯。与和 没有动力外骨骼，将使用便携式代谢推车进行6分钟的步行测试评估。 QOL的其他探索结果度量将使用SF-36和PENTOK CHATEN 生活质量规模。 两组的基线测试将在没有设备的情况下进行卧床进行操作 从培训计划开始。外骨骼组将重复测试 培训计划。 36次培训后，将获得后评估。保留将由 停止培训计划1个月后，在没有外骨骼的情况下重复评估。 可以预计，使用该设备的纵向训练将增加可实现的下蹲数量， 增加挥杆过程中的膝盖屈曲，增加右肢的负载，并诱导对称步进。不 但是，预计将对设备对能源消耗的直接影响，但预计培训效果将会 证明行走能源成本的改善。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，并证明 可以保留此设备的处方。使用此设备也可能导致 改进QOL。