A Novel Strategy to Decrease Fall Incidence Post-Stroke

 描述(由申请人提供)： 背景/目的：跌倒是中风后常见且代价高昂的并发症。虽然残存的行走和平衡障碍在很大程度上导致了长期的残疾，但对这一人群来说，更令人担忧的是跌倒的发生率。40%到70%的人在中风后的第一年内患病。跌倒的人会增加严重不良后果的发生率，包括骨折、抑郁症和死亡率。中风康复的一个主要目标是在存在运动、平衡和视觉空间缺陷的情况下改善活动能力。所有利益相关者都必须面对的难题是，活动增加可能会增加跌倒的风险，而限制步行和一般活动将导致与不活动相关的大量缺陷，包括反复中风。由于这些严重的后果，迫切需要对中风退伍军人进行康复，既要识别有跌倒风险的人，又要制定干预策略，在减少跌倒发生率的同时增加活动能力。最近，倒退行走既是跌倒发生率的潜在预测指标，也是预防未来跌倒的一种干预方式。然而，它还没有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，目的有三个：1)中风后早期进行后向行走训练对减少跌倒的有效性；2)后向行走训练对提高后向行走速度的时机；3)后向行走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。研究对象：128名中风后2个月的受试者。其他研究标准包括：1)步行速度<lt；0.8米/S；2)社区生活；3)Berg平衡量表&lt；42；4)无其他神经系统疾病；5)退出物理治疗服务；6)心脏状况稳定；7)没有限制步态能力的下肢矫形损伤或疼痛。方法：在基线评估后，参与者将在卒中后2个月(即刻组)或卒中后1年(延迟组)随机接受体重训练。干预包括18次BW训练(每周3次，为期6周)：使用体重支持和跑步机系统(BWST)进行20-30分钟的步态训练，然后由物理治疗师领导的团队进行15分钟的地面步态训练。参与者将在必要的协助下在地面上向后行走，将步法从BWST环境转移到地面上。即时组将被前瞻性地跟踪1年，并与延迟组进行比较，以确定体重训练在减少跌倒方面的有效性(具体目标1)。干预后的体重速度将在不同组之间进行比较，以评估体重训练的时间效应(特定目标2)。延迟组将在体重训练前前瞻性跟踪1年，以确定2个月的体重速度是否是中风后第一年跌倒发生率的预测因素(具体目标3)。结果指标：卒中后2个月至1年的跌倒发生率是我们的主要结果指标。二次测量包括前后行走步态速度、功能步态评估中的动态平衡、活动平衡置信度和步态运动学中的跌倒自我效能感。数据分析计划：计算即时干预组和延迟干预组每个患者每月跌倒的总次数，并使用非参数比率估计，确定每组平均危险的点和间隔估计。两个个体群体估计的比率、95%的置信限和P值将得到。采用多因素逐步Logistic回归分析延迟干预组患者卒中后2个月体重速度与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.