A Novel Strategy to Decrease Fall Incidence Post-Stroke

 描述（由申请人提供）： 背景/目的：福尔斯是卒中后常见且昂贵的并发症。虽然残留的行走和平衡缺陷对长期残疾有很大的影响，但对这一人群更大的关注是福尔斯的发生率。40%到70%的人在中风后的第一年内就发病了。跌倒的人严重不良后果的发生率增加，包括骨折、抑郁和死亡。中风康复的主要目标是改善存在运动、平衡和视觉空间缺陷的患者的活动能力。所有利益相关者必须面对的难题是，增加的活动可能会增加福尔斯的风险，而限制行走和一般活动将导致与不活动相关的多种缺陷，包括复发性中风。由于这些严重的后果，有一个迫切需要在退伍军人中风康复，以确定那些谁是跌倒的风险，并制定干预策略，将减少跌倒的发生率，同时增加流动性。最近，向后行走已成为跌倒发生率的潜在预测因素，也是预防未来福尔斯的干预方式。然而，它尚未在严格的对照试验下进行评估。我们将进行一项随机对照试验，有三个具体目标，以检查1）卒中后早期后退行走训练（BW训练）在减少福尔斯方面的有效性，2）BW训练提供的时间以增加后退行走速度（BW速度），以及3）BW速度与预期跌倒发生率之间的关系。研究设计：这是一项随机单盲对照试验。受试者：128名卒中后2个月的受试者将参与研究。其他研究标准包括：1）步行能力，步态速度< 0.8 m/s; 2）社区居住; 3）贝格平衡量表< 42; 4）无其他神经系统疾病; 5）从物理治疗服务中出院; 6）心脏状态稳定; 7）无下肢矫形障碍或限制步态能力的疼痛。研究方法：基线评估后，受试者将在卒中后2个月（即刻组）或1年（延迟组）时随机接受BW训练。干预包括18次BW训练（每周3次，持续6周）：使用体重支持和跑步机系统（BWST）进行20-30分钟的台阶训练，然后由物理治疗师领导的团队进行15分钟的地上步态训练。参加者将在地面上向后行走，并根据需要将踏步技能从BWST环境转移到地面上。将前瞻性随访即刻组1年，并与延迟组进行比较，以确定BW训练在减少福尔斯方面的有效性（具体目标#1）。将在两组之间比较干预后的BW速度，以评估BW训练的时间效应（具体目标#2）。延迟组将在BW训练前前瞻性随访1年，以确定2个月时的BW速度是否是卒中后第一年跌倒发生率的预测因子（具体目标#3）。结果测量：卒中后2个月至1年的跌倒发生率是我们的主要结果测量。次要指标包括向前和向后行走步态速度、通过功能性步态评估测量的动态平衡、通过活动-平衡信心量表测量的跌倒自我效能和步态运动学。数据分析计划：将计算立即干预组和延迟干预组每个患者月的福尔斯总跌倒次数，并使用非参数比率估计值确定每组平均风险的点和区间估计值。将获得两个单独组估计值的比值、95%置信限和P值。将使用前向逐步有序logistic回归确定延迟干预组中卒中后2个月的BWSpeed与1年跌倒发生率之间的独立关系。

 DESCRIPTION (provided by applicant): Background/Purpose: Falls are a common and costly complication following stroke. While residual walking and balance deficits contribute substantially to long-term disability, of greater concern for this population is the incidence of falls. Between 40% and 70% of individuals fall within their first year post-stroke. Individuals who fall have increased incidence of serious adverse outcomes, including fractures, depression, and mortality. A primary goal of stroke rehabilitation is to improve mobility in the presence of motor, balance, and visual-spatial deficit. The conundrum all stakeholders must face is that increased mobility may increase risk for falls, whereas limiting walking and general mobility will lead to a multitude of deficits associated with inactivity, including recurrent stroke. Because of these serious consequences, there is an urgent need in the rehabilitation of Veterans with stroke to both identify those who are at fall risk and develop intervention strategies that will reduce fall incidence while increasing mobility. Backward walking has recently emerged as both a potential predictor of fall incidence as well as an intervention modality to prevent future falls. However, it has not yet been assessed under the rigors of a controlled trial. We will conduct a randomized controlled trial with three specific aim to examine 1) the effectiveness of Backward Walking Training (BWTraining) early post- stroke in decreasing falls, 2) the timing of BWTraining delivery to increase Backward Walking speed (BWSpeed), and 3) the relationship between BWSpeed and prospective fall incidence. Study Design: This is a randomized single-blind controlled trial. Subjects: One-hundred twenty-eight individuals, 2 months post-stroke, will participate. Additional study criteria include: 1) ambulatoy with gait speed < 0.8 m/s; 2) community-dwelling; 3) Berg Balance Scale < 42; 4) absence of other neurological conditions; 5) discharged from physical therapy services; 6) stable cardiac status; 7) absence of lower extremity orthopedic impairments or pain that limits gait ability. Methods: Following baseline assessment, participants will be randomized to BWTraining at 2 months (Immediate group) or 1-year post-stroke (Delayed group). The intervention consists of 18 sessions (3X/week for 6 weeks) of BWTraining: 20-30 minutes of step training using a Body Weight Support and Treadmill system (BWST) followed by 15 minutes of overground gait training delivered by a physical therapist-led team. Participants will walk backward overground with assistance as warranted to transfer stepping skills from the BWST environment to overground. The Immediate group will be followed prospectively for 1-year and compared to the Delayed group to determine the effectiveness of BWTraining in decreasing falls (Specific Aim #1). BWSpeed post-intervention will be compared between groups to assess the timing effect of BWTraining (Specific Aim #2). The Delayed group will be followed prospectively for 1-year prior to BWTraining, to determine if BWSpeed at 2-months is a predictor of fall incidence in the first year post-stroke (Specific Aim #3). Outcome Measures: Fall incidence 2-months to 1-year post-stroke is our primary outcome measure. Secondary measures include forward and backward walking gait speed, dynamic balance measured by the Functional Gait Assessment, fall self-efficacy measured by the Activities-Balance Confidence Scale and gait kinematics. Data Analysis Plan: The total number of falls per patient month for the immediate and delayed intervention groups will be calculated, and using a nonparametric ratio estimate, point and interval estimates for the average hazard for each group will be determined. The ratio of the two individual group estimates, 95% confidence limits and P-values will be obtained. Forward stepwise ordinal logistic regression will be used to determine the independent relationship between BWSpeed at 2-months post-stroke and 1-year fall incidence of those in the Delayed intervention group.