Improving ambulatory community access after paralysis

改善瘫痪后的社区流动性

• 批准号: 8276637
• 负责人: Rudi Kobetic
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-10-01 至 2015-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8276637
• 关键词: Abnormal coordination; Address; Algorithms; Ankle; Braces-Orthopedic appliances; Clinical Trials; Cognitive; Communities; Crowding; Crural Paresis; Detection; Disabled Persons; Education; Effectiveness; Electric Stimulation; Electrodes; Energy Metabolism; Evaluation; Event; Exercise; Feasibility Studies; Flexor; Floor; Foundations; Gait; Health; Healthcare; Healthcare Systems; Hip region structure; Home environment; Household; Impairment; Implant; Individual; Injury; Intervention; Intramuscular; Knee; Laboratories; Leg; Leisure Activities; Life Style; Long-Term Care; Lower Extremity; Measures; Metabolic; Methodology; Muscle; Outcome; Paralysed; Paraplegia; Paresis; Patient Self-Report; Perceived quality of life; Persons; Physiologic pulse; Physiological; Population; Procedures; Quality of life; Rehabilitation therapy; Research; Residual state; SF-36; Safety; Sickness Impact Profile; Social isolation; Speed; Spinal cord injury; System; Technology; Testing; Time; Training; Veterans; Walking; Work; ankle joint dorsiflexor; base; clinically significant; cost; disability; falls; follow-up; foot; gait correction; high risk; impression; improved; inclusion criteria; indexing; instrument; kinematics; meetings; muscle strength; neuroprosthesis; novel; post intervention; response; satisfaction; sensor; social; tool; volunteer

DESCRIPTION (provided by applicant): Objective - The objective of this feasibility study of safety and effectiveness of an implanted multichannel functional electrical stimulation (FES) gait system is to correct gait instability and increase walking speed to improve ambulatory community access of persons with lower extremity paralysis due to incomplete spinal cord injury (ISCI). Research Plan - Individuals with lower extremity weakness from ISCI will be screened for difficulty initiating a step and inefficien forward propulsion. These include individuals with weak hip and knee flexors and ankle dorsiflexors for initiating a step and weak hip flexors, ankle plantar flexor and hip extensors for generating the power for forward propulsion. If meeting inclusion criteria they will undergo baseline gait evaluation and have an 8-channel implantable pulse generator (IPG) and intramuscular electrodes surgically installed to correct their gait deficit. After a period of recoery they will begin with FES exercise and 18 sessions of FES- assisted gait training. They will be reevaluated before discharged for home use and again at 3, 6, 9, and 12 month follow-up for ability to initiate a step and for ability to generate power to move the body forward for improved walking speed. Methodology - In this study each of the six subjects with lower extremity paresis will serve as their own control. Extent of gait correction with IPG will be compared to individual' residual function without FES at pre- and post intervention. Number of trials for testing walking speed, distance, and physiologic cost was determined based on statistical power of 90% for a 0.2m/s improvement in walking speed. Analysis will be applied to parameters from volitional function versus FES assisted gait to determine clinically and statistically significant improvements (p<0.05). To capture a user's measure of participation and quality of life, instruments that address various aspects of community ambulation including SF-36, Subjective Index of Social Outcome, and the Sickness Impact profile will be administered to assess community ambulation. Clinical Significance - Gait impairments in individuals with lower extremity paresis have been associated with increased complications such as injury from falls, social isolation from immobility and decreased quality of life measures. This project will demonstrate the feasibility of a multichannel implanted FES gait system as a neuroprosthetic tool for correction of stepping and increasing walking speed with improved community access and quality of life. The results will provide foundations for applying implanted FES technology to a much larger population in a clinical trial within VA health care and civilian population. PUBLIC HEALTH RELEVANCE: Lower extremity weakness due to paresis or increased extensor tone with lack of coordination places severe limitations on person's ability to walk, thus compromising the ability to work, engage in social or leisure activities, pursue an education or participate in other activities of a independent and productive lifestyle. A novel application of implanted functional electrical stimulation to correct their gait deficits will allow disabled veterans to walk faster and farther ith less effort and with less chance of tripping and falling, thus providing them with improved community access. Being able to walk should significantly improve their quality of life by reducing their disability.

描述（由申请人提供）： 目的 - 这项关于植入式多通道功能性电刺激 (FES) 步态系统的安全性和有效性的可行性研究的目的是纠正步态不稳定性和 提高步行速度，以改善因不完全脊髓损伤 (ISCI) 导致的下肢瘫痪患者的步行社区通行。研究计划 - 对因 ISCI 导致下肢无力的个体进行筛查，以确定其迈步困难和向前推进效率低下的情况。这些包括用于启动步的髋部、膝部屈肌和踝背屈肌较弱的个体，以及用于启动步的髋部屈肌、踝关节跖屈肌和髋部伸肌较弱的个体。 产生向前推进的动力。如果符合纳入标准，他们将接受基线步态评估，并通过手术安装 8 通道植入式脉冲发生器 (IPG) 和肌内电极来纠正步态缺陷。经过一段时间的恢复后，他们将开始 FES 锻炼和 18 次 FES 辅助步态训练。他们将在出院回家前进行重新评估，并在 3、6、9 和 12 个月的随访时再次评估其迈出步伐的能力以及产生推动身体向前移动以提高步行速度的能力。方法 - 在这项研究中，六名患有下肢麻痹的受试者中的每一位都将作为自己的对照。将在干预前后将 IPG 步态矫正的程度与不使用 FES 的个体残余功能进行比较。测试步行速度、距离和生理成本的试验次数是根据步行速度提高 0.2m/s 的 90% 统计功效确定的。将分析意志功能与 FES 辅助步态的参数，以确定临床和统计学上的显着改善（p<0.05）。为了捕获用户对参与和生活质量的衡量标准，将使用解决社区步行各个方面的工具（包括 SF-36、社会结果主观指数和疾病影响概况）来评估社区步行。临床意义 - 下肢麻痹患者的步态障碍与并发症增加有关，例如跌倒受伤、因不动而导致的社会孤立和生活质量下降。该项目将展示多通道植入式 FES 步态系统作为神经假体工具的可行性，用于矫正步态和提高步行速度，从而改善社区访问和生活质量。研究结果将为在 VA 医疗保健和平民群体的临床试验中将植入式 FES 技术应用于更广泛的人群奠定基础。 公共卫生相关性： 由于麻痹或伸肌张力增加而缺乏协调而导致的下肢无力，严重限制了人的行走能力，从而损害了工作、参加社交或休闲活动、接受教育或参加其他独立和生产性活动的能力生活方式。一种通过植入功能性电刺激来纠正步态缺陷的新颖应用将使残疾退伍军人能够以更少的努力走得更快、更远，并且绊倒和跌倒的机会也更少，从而为他们提供更好的社区通道。能够行走应该可以通过减少残疾来显着提高他们的生活质量。