Improving ambulatory community access after paralysis

描述(由申请人提供)： 目的：植入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和 提高步行速度，改善因不完全性脊髓损伤(ISCI)而导致的下肢瘫痪患者的非卧床社区通道。研究计划-来自ISCI的下肢无力的个体将被筛查为启动一步困难和向前推进效率低下的人。这些包括髋关节和膝关节屈肌和踝关节背屈肌无力的人，以及髋屈肌无力的人，脚踝足底屈肌和髋伸肌弱的人。 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，并通过外科手术安装8通道植入式脉冲发生器(IPG)和肌肉内电极，以纠正他们的步态缺陷。经过一段时间的恢复后，他们将开始进行FES锻炼和18节FES辅助步态训练。他们将在出院回家前重新评估，并在3、6、9和12个月的随访中再次评估启动一步的能力和产生能量以向前移动身体以提高行走速度的能力。研究方法--在本研究中，六名患肢轻瘫的受试者各自作为自身对照。使用IPG的步态矫正程度将与干预前和干预后未使用FES的个体的残余功能进行比较。测试步行速度、距离和生理成本的试验次数是基于步行速度提高0.2m/S的90%的统计功率来确定的。分析将应用于意志功能和FES辅助步态的参数，以确定临床和统计学上显著的改善(p&lt；0.05)。为了捕捉用户对参与和生活质量的测量，将使用解决社区步行的各个方面的工具，包括SF-36、社会结果主观指数和疾病影响概况，以评估社区步行。临床意义--下肢瘫痪患者的步态障碍与并发症的增加有关，如跌倒造成的损伤、与社会隔离而不能活动以及生活质量指标下降。该项目将展示多通道植入的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，并改善社区通道和生活质量。这一结果将为在退伍军人管理局医疗保健和平民人群中进行临床试验中将植入的FES技术应用于更大规模的人群提供基础。 公共卫生相关性： 由于瘫痪或伸肌张力增加而缺乏协调性的肢体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、接受教育或参与独立和富有成效的生活方式的其他活动的能力。一种植入功能性电刺激以纠正步态缺陷的新应用将使残疾退伍军人能够以更少的努力走得更快更远，绊倒和摔倒的机会也更少，从而为他们提供更好的社区通道。能够走路应该会通过减少他们的残疾来显著提高他们的生活质量。

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.