Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

Objectives
Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke.
Design
This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services
Participants
Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments
Intervention
Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks.
Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up.
Results
Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms.
Conclusions
Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention.
Trial Registration
Clinicaltrials.gov NCT01600391

**研究目标**
鉴于视觉在步行控制中的重要作用，且已有证据表明多样化步行训练可改善移动能力结局，本研究旨在探索基于视觉线索（visual cues）的多样化步行训练用于脑卒中（stroke）后步行康复的可行性与初步疗效。

**研究设计**
本研究为三臂平行、多中心、评估者盲法随机对照试验（randomised control trial），在门诊神经康复服务机构开展。

**研究对象**
社区居住的脑卒中（stroke）幸存者，步行速度<0.8m/s，存在下肢轻瘫（lower limb paresis）且无严重视觉障碍。

**干预方案**
由物理治疗师（physiotherapist）实施以下三种方案：地面步行视觉线索训练（Over-ground visual cue training, O-VCT）、跑步机步行视觉线索训练（Treadmill based visual cue training, T-VCT）以及常规护理（Usual care, UC），每周干预2次，持续8周。

**主要结局指标**
采用计算机生成的随机置换平衡区组（区组大小随机变化）方法进行随机分组。在随机分组前、干预结束后及4周随访时，分别评估招募率、保留率、依从性、不良事件发生情况，以及移动能力与平衡能力。

**研究结果**
共纳入56名受试者，其中T-VCT组18例、O-VCT组19例、UC组19例。最终34名受试者完成治疗及随访评估。在完成研究的受试者中，各组依从性良好，T-VCT组、O-VCT组、UC组分别完成了中位时长8.4、7.5、9周的共16次治疗。未报告任何不良事件。所有干预组均观察到干预后步行速度、步行对称性、平衡能力及功能移动能力的显著改善。

**研究结论**
基于门诊的跑步机及地面步行视觉线索适应性训练方案具备可行性，或可有效改善移动能力与平衡能力。未来研究应沿用经验证的分阶段实施策略，以提升受试者保留率。

**试验注册**
ClinicalTrials.gov NCT01600391