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

便携式外骨骼改善帕金森病患者活动能力的可行性和安全性

• 批准号: 10702193
• 负责人: Mark S Baron
• 金额: --
• 依托单位: VA VETERANS ADMINISTRATION HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10702193
• 关键词: Activities of Daily Living; Adverse event; Aging; Alabama; Amputation; Bilateral; Body Height; Body Weight; Brain; Canes; Caregivers; Characteristics; Chronic Obstructive Pulmonary Disease; Clinic; Clinical Research; Clinical Trials; Collaborations; Crutches; Data; Deep Brain Stimulation; Dementia; Devices; Disabled Persons; Disease; Effectiveness; Enteral Feeding; Equilibrium; Exclusion Criteria; Exercise; Exertion; Fogs; Freezing; Funding; Future; Gait; Goals; Grant; Hand; Home; Hypotensives; Impaired cognition; Impairment; Individual; Intervention; Investigation; Leadership; Leg; Levodopa; Life; Life Style; Lower Extremity; Measures; Medical center; Modality; Modernization; Movement Disorder Society Unified Parkinson' s Disease Rating Scale; Movement Disorders; Multi-Institutional Clinical Trial; Multi-site clinical study; Musculoskeletal; Nervous System Trauma; Neurologic; Neurology; Nose; Operative Surgical Procedures; Orthostasis; Orthostatic Hypotension; Outcome; Pain; Paralysed; Paraplegia; Parkinson Disease; Parkinsonian Disorders; Patients; Persons; Pharmaceutical Preparations; Physical Exercise; Physical therapy; Pilot Projects; Population; Positioning Attribute; Posture; Productivity; Qualifying; Quality of life; Questionnaires; Recording of previous events; Rehabilitation therapy; Research; Research Personnel; Resistance; Robotics; Role; Running; Safety; Sampling; Seasons; Self-Help Devices; Severities; Severity of illness; Skin injury; Specialist; Stroke; Supervision; Symptoms; Technology; Testing; Therapeutic; Therapeutic Intervention; Training; Treatment Efficacy; Universities; Veterans; Virginia; Visit; Walking; Wheelchairs; Work; cardiac device; cardiac implant; clinical center; cognitive testing; design; disability; exercise training; exoskeleton; exoskeleton device; experience; falls; gait rehabilitation; improved mobility; inclusion criteria; independent ambulation; light weight; mobility aid; musculoskeletal injury; participant interview; physical therapist; portability; primary endpoint; recruit; research and development; resistance exercise; safety and feasibility; safety assessment; skin irritation; standard of care; treadmill training; walker; wearable device

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.

目前以渐进式阻力运动训练、高强度跑步机训练、平衡训练为主 利用扰动和标准体育锻炼来治疗与帕金森病相关的活动能力缺陷； 然而，这些疗法的有效性是有限的。本研究旨在调查一种疗法的效用。 为帕金森病患者设计的便携式外骨骼的目标是建立一种安全的轻型便携式外骨骼。 外骨骼 Keeogo，用于步态训练并初步评估其步态灵活性的潜在功效 由于绝大多数 PD 患者最终需要便携式辅助移动设备。 外骨骼代表了提高机动性、生活质量和机器人辅助的途径。 步态训练（RAGT）作为一种卓越的治疗方式已被广泛应用，因此 使患有严重神经损伤的高度积极的人能够重新获得独立行走。 尽管这项技术有可能改变帕金森病患者的生活，但这些设备并不能 正在对患有运动障碍的人进行充分的研究。 初步确定 Keeogo 外骨骼对各种疾病的 PD 患者的安全性和有效性 阶段，我们将检查 Hohen & Yahr 阶段 II、III、IV 和 V 中的代表性受试者。纳入标准 是：1) 由 PADRECC 运动障碍专家使用英国脑库标准确认的 PD，2) 修改后的 H&Y II-V 期排除标准为：1) 神经、肌肉骨骼或其他疾病。 与导致姿势、步态、平衡或协调受损的 PD 无关，2) 严重 CHF、COPD、 或需要鼻导管 O2 的患者，3) 植入式心脏装置或消融手术史，4) 中度 严重认知障碍/痴呆（蒙特利尔认知评估<17/30），5）有症状 体力性低血压，6) 饲管或相关端口放置 (PEG/J-PEG)，7) 身体 身高小于 5 英尺 1 英寸或大于 6 英尺 3 英寸 8) 体重大于 250 磅，以及 9) 截肢 受试者将使用 Keeogo 参加总共 30 分钟的 RAGT 行走 每周两次，持续 6 周（12 次）。受试者可以选择使用滚动步行器、滚动步行器、 双侧 Lofstrand 拐杖或单侧装置，例如手杖或 Lofstrand 拐杖，并将予以维护 在整个干预过程中。 确定安全性、不良事件的数量和严重程度，例如跌倒、不适、皮肤或肌肉骨骼 损伤和直立性低血压发作将被记录在案。 以及每两周干预访视和研究后 6 周时佩戴 Keeogo 外骨骼后的情况 步行能力，包括 FoG 的益处，将通过六分钟步行测试 (6MWT) 进行评估， 使用 Berg 平衡量表 (BBS) 评估平衡和姿势稳定性，并使用 统一帕金森病评定量表 (UPDRS) 的检查，第三部分 附加评估。 将包括 Berg 平衡量表 (BBS)、上升和下降楼梯攀爬、PDQ39、The University 阿拉巴马州伯明翰 (UAB) 老龄化生活空间评估 (LSA) 研究和 PD 护理人员作为主要项目。 为了确定功效的终点，将在训练结束和基线之间比较 6MWT（与 和没有外骨骼），以及研究后 6 周和 12 周作为耐久性评估 这些试点调查预计将确定未来评估家庭使用情况的需要。 为大型多中心临床研究奠定基础，将地面外骨骼建立为现代标准 帮助退伍军人和其他患有帕金森症和其他致残性运动障碍的人的护理设备 保持更加正常和富有成效的生活。