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 - 这项可行性研究的目的是植入的多通道功能电刺激（FES）步态系统的安全性和有效性的目的是纠正步态不稳定性和 提高步行速度以改善由于不完全脊髓损伤（ISCI）而导致下肢瘫痪者的门诊社区的通道。研究计划 - ISCI的下肢无力的人将被筛选，以启动步骤和效率低下的前进推进。其中包括臀部和膝盖屈曲弱的个体以及脚踝背屈，用于启动步骤和较弱 产生向前推进的力量。如果符合纳入标准，他们将接受基线步态评估，并具有8通道植入脉冲发生器（IPG）和肌内电极的手术安装以纠正其步态缺陷。经过一段时间的回顾，他们将从FES练习和18次FES辅助步态训练开始。它们将在出院之前对其进行重新评估，并在3、6、9和12个月的随访中再次进行，以便能够启动步骤和能够产生力量以提高步行速度以提高身体的能力。方法论 - 在这项研究中，六个具有下肢轻瘫的受试者中的每一个都将作为他们自己的控制。在干预前后，将使用IPG进行步态校正的程度将与没有FES的单个剩余功能进行比较。测试步行速度，距离和生理成本的试验次数是根据90％的统计能力确定的，步行速度提高了0.2m/s。分析将应用于意志功能与FES辅助步态的参数，以确定临床和统计学上显着的改进（P <0.05）。为了捕捉用户的参与度和生活质量的衡量标准，将对社区移动的各个方面的工具进行处理，包括SF-36，社会成果的主观指数以及疾病影响概况，以评估社区的流动。临床意义 - 下肢轻瘫患者的步态障碍与并发症的增加有关，例如跌倒，社会隔离，与不动的社会隔离以及生活质量降低。该项目将证明多通道植入的FES步态系统作为一种神经假体工具的可行性，可通过改善社区的访问和生活质量来纠正步进和提高步行速度。该结果将为VA医疗保健和平民人口的临床试验中的临床试验中，将植入的FES技术应用于更大的人群中的基础。 公共卫生相关性： 由于减轻或缺乏协调而导致的下肢弱点，由于缺乏协调，对人的行走能力有严重限制，从而损害了工作能力，从事社交或休闲活动，从事教育或参加独立和生产力的生活方式的其他活动。植入功能性电刺激的新型应用以纠正其步态缺陷，将使残疾退伍军人步行更快，更少的努力，而绊倒和下降的机会更少，从而为他们提供了改善的社区访问。能够走路应通过减少残疾来大大改善其生活质量。