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.

90%的中风幸存者有临床显著的步态障碍，导致继发性 医疗并发症，包括心血管失调和生活质量（QOL）下降。几 提高活动和流动水平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所带来的挑战需要经常访问一个 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，以改善在家庭和社区的流动性。虽然主要的研究使用 这些装置已经用于脊髓损伤患者，目前有两种装置获得FDA批准 用于中风患者，并且正在开发另外的装置。Keeogo动力矫形器 外骨骼是一种新型装置，用于能够行走但有步态障碍的中风患者。这 一种装置由一个脊状的矫形结构和电池组成，该矫形结构放置在腿部的衣服上，电池为马达提供动力 帮助双膝进行步态运动。系统监测用户驱动的髋关节运动，并解释 该运动用于在膝关节处施加适当的辅助。这种独特的方法使学习 直观，使用户只适应系统，而不是学习如何控制设备， 启动所需的运动。 本方案为随机对照初探性研究。15名慢性卒中退伍军人（> 6个月） 并且那些保持一定的行走能力但步态受损的人将被招募。10名参与者将 随机分为外骨骼组和对照组。两组都将被要求完成36项 一小时的业余训练。外骨骼小组将使用Keeogo动力矫形器进行训练 外骨骼组和对照组将在不使用他们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功效及其提高 转移到站立和坐下，如通过五次坐到站测试所评估的。第二个目标是评估 设备在地上安装期间的影响。研究膝关节范围变化的结局测量 运动和轻瘫肢体的负荷的变化将使用仪器测角器完成; 将使用足部压力测绘系统监测肢体负荷，并记录踏步参数 用的是盖特利特地毯一个探索性的结果，在能源消耗的变化， 将使用便携式代谢推车通过6分钟步行测试来评估没有动力外骨骼的人。 将使用SF-36和卒中特异性量表确定QOL的其他探索性结局指标 生活质量量表。 两组的基线测试将在无器械行走时和 从训练计划开始。外骨骼组将在前3个阶段内重复测试。 培训计划。36期培训结束后将进行岗位评估。保留将由以下人员评估： 在停止所述训练程序1个月后，在没有所述外骨骼的情况下重复所述评估。 预计使用该装置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，增加麻痹肢体的负荷，并诱导对称踏步。没有 预期该装置对能量消耗的直接影响，然而，预期训练效果 证明了节能减排的成效。本研究期间观察到的任何收益可能不会 保留，但由于该设备具有在家庭和社区环境中使用的潜力， 可能需要为保留目的开具该器械的处方。使用该器械还可能导致 改善QOL。