Institute for Health and Sport (IHES), Victoria University, Footscray Park Campus (Room PB307), PO Box 14428, Melbourne, VIC, 8001, Australia.
Royal Melbourne Hospital, Australian Rehabilitation Research Centre, Parkville, Victoria, 3010, Australia.
Trials. 2019 May 31;20(1):317. doi: 10.1186/s13063-019-3404-6.
The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum toe clearance (MTC) is the key gait cycle event for predicting tripping-falls because it occurs mid-swing during the walking cycle where forward velocity of the foot is maximum. High forward velocity coupled with low MTC increases the probability of unanticipated foot-ground contacts. Training procedures to increase toe-ground clearance (MTC) have potential, therefore, as a falls-prevention intervention. The aim of this project is to determine whether augmented sensory information via real-time visual biofeedback during gait training can increase MTC.
Participants will be aged > 18 years, have sustained a single stroke (ischemic or hemorrhagic) at least six months previously, able to walk 50 m independently, and capable of informed consent. Using a secure web-based application (REDCap), 150 participants will be randomly assigned to either no-feedback (Control) or feedback (Experimental) groups; all will receive 10 sessions of treadmill training for up to 10 min at a self-selected speed over 5-6 weeks. The intervention group will receive real-time, visual biofeedback of MTC during training and will be asked to modify their gait pattern to match a required "target" criterion. Biofeedback is continuous for the first six sessions then progressively reduced (faded) across the remaining four sessions. Control participants will walk on the treadmill without biofeedback. Gait assessments are conducted at baseline, immediately following the final training session and then during follow-up, at one, three, and six months. The primary outcome measure is MTC. Monthly falls calendars will also be collected for 12 months from enrolment.
The project will contribute to understanding how stroke-related changes to sensory and motor processes influence gait biomechanics and associated tripping risk. The research findings will guide our work in gait rehabilitation following stroke and may reduce falls rates. Treadmill training procedures incorporating continuous real-time feedback may need to be modified to accommodate stroke patients who have greater difficulties with treadmill walking.
Australia New Zealand Clinical Trials Registry, ACTRN12617000250336 . Registered on 17 February 2017.
慢性中风患者跌倒的风险显著增加,因此,设计干预措施以提高活动能力和降低跌倒风险非常重要。最小脚趾离地间隙(MTC)是预测绊倒跌倒的关键步态事件,因为它发生在步行周期的摆动中期,此时脚的向前速度最大。高向前速度加上低 MTC 增加了脚部与地面意外接触的可能性。因此,增加脚趾离地间隙(MTC)的训练程序有潜力作为预防跌倒的干预措施。本项目的目的是确定在步态训练过程中通过实时视觉生物反馈增加 MTC 是否可行。
参与者年龄应大于 18 岁,在至少六个月前曾患有单侧中风(缺血性或出血性),能够独立行走 50 米,并且能够知情同意。使用安全的基于网络的应用程序(REDCap),将 150 名参与者随机分配到无反馈(对照组)或反馈(实验组)组;所有参与者将在 5-6 周内接受 10 次跑步机训练,每次训练时长最多 10 分钟,速度为自选。实验组在训练过程中会收到 MTC 的实时视觉生物反馈,并被要求修改其步态模式以匹配所需的“目标”标准。在最初的六次训练中,生物反馈是连续的,然后在剩余的四次训练中逐渐减少(淡出)。对照组参与者将在没有生物反馈的情况下在跑步机上行走。在基线、最后一次训练结束后以及随后的随访中,在 1、3 和 6 个月时进行步态评估。主要结果指标为 MTC。从入组开始,参与者还将每月填写 12 个月的跌倒日历。
该项目将有助于了解与中风相关的感觉和运动过程的变化如何影响步态生物力学和相关的绊倒风险。研究结果将指导我们在中风后的步态康复工作,并可能降低跌倒率。可能需要对纳入连续实时反馈的跑步机训练程序进行修改,以适应那些在跑步机行走方面有更大困难的中风患者。
澳大利亚新西兰临床试验注册中心,ACTRN12617000250336。于 2017 年 2 月 17 日注册。