Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson’s Disease

目前，渐进式抗阻运动训练、大强度跑步机训练、平衡式训练 干扰和标准体育锻炼用于治疗与帕金森病相关的活动能力障碍； 然而，这些疗法的有效性是有限的。这项研究建议调查一项 为帕金森病患者设计的便携式外骨骼。其目标是建立一种轻便便携的安全性 用于步态训练的外骨骼Keeogo，并初步评估其对步态活动的潜在疗效 并减少跌倒。由于绝大多数帕金森氏症患者最终需要辅助活动装置，便携式 外骨骼代表着一条提高流动性、提高生活质量和独立性的途径。机器人辅助 步态训练(RAGT)作为一种值得注意的治疗方式得到了广泛的应用，因此它 使饱受严重神经损伤的上进心强的人能够恢复独立行走。 尽管这项技术有可能改变帕金森氏症患者的生活，但这些设备并没有 在有运动障碍的人中进行了充分的研究。 初步建立Keeogo外骨骼在各种疾病帕金森病患者中的安全性和有效性 阶段，我们将考察Hohen&Yahr阶段II、III、IV和V阶段的代表性科目。 是：1)PADRECC运动障碍专家使用英国脑库标准确认的帕金森病，2) 改进的H&Y阶段II-V排除标准为：1)神经、肌肉骨骼或其他疾病 与导致站立、步态、平衡或协调障碍的帕金森病无关，2)严重的CHF、COPD、 或需要鼻导管氧气，3)植入心脏装置或消融手术病史，4)中等 到严重认知障碍/痴呆症(蒙特利尔认知评估和lt；17/30)，5)有症状 用力直立性低血压，6)饲管或相关端口放置(聚乙二醇/J-聚乙二醇)，7)身体 身高小于5英尺1英寸或大于6英尺3英寸8)体重超过250磅，以及9)截肢 下肢的一部分。受试者将参与总共30分钟的RAGT步行与Keeogo 每周两次，共6周(12次)。受试者可以选择使用站台滚步机、滚步机、 双侧低线拐杖或单边装置，如拐杖或低线拐杖，并将予以维护 在整个干预过程中。 为确定安全性，不良事件的数量和严重程度，如跌倒、不适、皮肤或肌肉骨骼 受伤和直立性低血压发作将被记录在案。干预效果将在 在每两周一次的干预访问中和在为期6周的研究后佩戴Keeogo外骨骼 参观。步行能力，包括雾天带来的益处，将通过六分钟步行测试(6MWT)进行评估， 平衡和姿势稳定性与Berg平衡量表(BBS)，以及疾病严重性与 帕金森氏病统一评定量表(UPDRS)第三部分的检查。额外课税 将包括Berg Balance Scale(BBS)、上升和下降楼梯攀登、PDQ39、 阿拉巴马州伯明翰分校(UAB)老龄化生活空间评估(LSA)研究，以及PD-CARE。作为初选 建立疗效的终点，将在训练结束和基线之间比较6MWT(与 没有外骨骼)，以及在研究后6周和12周作为对 确定未来对家庭使用情况进行评估的必要性。这些试点调查预计将 为将地面外骨骼建立为现代、标准的大型多中心临床研究奠定基础 帮助退伍军人和其他患有帕金森氏症和其他致残运动障碍的人的护理设备 保持更正常和更有成效的生活。

Currently, progressive resistance exercise training, high intensity treadmill training, balanced-based perturbation, and standard physical exercises are utilized to treat mobility deficits associated with PD; however, the effectiveness of these therapies is limited. This study proposes to investigate the utility of a portable exoskeleton for people with PD. The goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait training and to preliminarily assess its potential efficacy for gait mobility and fall reduction. As the vast majority of PD patients eventually require assistive mobility devices, portable exoskeletons represents an avenue for increased, mobility, quality of life, and independence. Robotic-assist gait training (RAGT) has been extensively applied as a remarkable therapeutic modality, such that it is enabling highly motivated people with devastating neurologic injuries to regain independent ambulation. Despite the potential for this technology to transform the lives of people with PD, these devices are not being adequately investigated in people with movement disorders. To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at various disease stages, we will examine representative subjects in Hohen & Yahr stages II, III, IV, and V. Inclusion criteria are: 1) PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria, 2) Modified H&Y stage II-V. Exclusion criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or those requiring nasal canula O2, 3) history of implantable cardiac device or ablative surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated port placement (PEG/J-PEG), 7) body height less than 5’1” or greater than 6’3” 8) body weight greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 6 weeks (12 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker, bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and will be maintained throughout the intervention. To establish safety, the number and severity of AEs, such as falls, discomfort, skin or musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly intervention visits, and at a 6-week post-study visit. Walking capacity, including benefits on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability with the Berg Balance Scale (BBS), and disease severity with the Examination, Part III, of the Unified Parkinson’s Disease Rating Scale (UPDRS). Additional assessments will include Berg Balance Scale (BBS), ascending and descending stair climb, PDQ39, The University of Alabama at Birmingham (UAB) Study of Aging Life-Space Assessment (LSA), and PD-Carer. As a primary end point for establishing efficacy, the 6MWT will be compared between end of training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks post-study as a durability assessment towards establishing a need for future assessment of in-home usage. These pilot investigations are expected to lay the groundwork for a large multi-center clinical study to establish ground exoskeletons as modern, standard of care devices to aid Veterans and other people with PD and other disabling movement disorders to maintain a more normal and productive life.