Peters Sue, Hung Stanley H, Bayley Mark T, Best Krista L, Connell Louise A, Donkers Sarah J, Dukelow Sean P, Ezeugwu Victor E, Milot Marie-Hélène, Sakakibara Brodie M, Sheehy Lisa, Wong Hubert, Yang Yuwei, Yao Jennifer, Eng Janice J
School of Physical Therapy, Faculty of Health Sciences, Elborn College, Western University, London, ON, Canada; Gray Centre for Mobility and Activity, Parkwood Institute, St Joseph's Health Care, Lawson Research Institute, London, ON, Canada; Rehabilitation Research Program, G F Strong Rehabilitation Centre, Vancouver, BC, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.
Rehabilitation Research Program, G F Strong Rehabilitation Centre, Vancouver, BC, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada; Centre for Aging Smart, Vancouver Coastal Health Institute, Vancouver, BC, Canada.
Lancet Neurol. 2025 Aug;24(8):643-655. doi: 10.1016/S1474-4422(25)00201-7.
Although clinical guidelines support high repetitions of walking after stroke, practice is slow to change. We undertook an implementation trial to enable entire stroke units to use the Walk 'n Watch structured, progressive exercise protocol. Our objective was to evaluate the effectiveness of the Walk 'n Watch implementation package on patient outcomes after 4 weeks in an inpatient stroke rehabilitation setting.
This pragmatic phase 3, stepped-wedge, cluster-randomised controlled trial took place in 12 sites (inpatient stroke rehabilitation units) across seven Canadian provinces. Each site was randomly allocated (1:1:1:1) to one of four transition sequences with three sites in each sequence. Sites changed practice from usual care to Walk 'n Watch at different times according to their allocation. All front-line physical therapists were trained to deliver the Walk 'n Watch protocol. Walk 'n Watch required completion of a minimum of 30 min of walking-related activities per session, which progressively increased in intensity based on heart rate and step count monitors. Progressions were prescribed on the basis of a screening 6-minute walk test (6MWT) done by the front-line physical therapist as part of the protocol. The primary endpoint was walking endurance (6MWT) at 4 weeks after randomisation. Masked assessors completed evaluations at baseline and 4 weeks later. The primary analysis used a linear mixed-effects model adjusted for unit size, stratum, calendar time, age, sex, and baseline 6MWT. This trial is registered with ClinicalTrials.gov, NCT04238260, and is complete.
Between June 4, 2021, and March 1, 2024, we enrolled 12 sites with 314 participants, of whom eight were deemed ineligible after enrolment and 306 were included in the primary analysis (162 in the usual care group, 144 in the Walk 'n Watch group). Participants had a mean age of 68 years (SD 13), a mean time since stroke of 29 days (17), and a baseline 6MWT of 152 m (106). 188 (61%) were male and 118 (39%) were female. The mean 6MWT in the usual care group was 137·1 m (100·9) at baseline and 223·6 m (130·4) after 4 weeks. The mean 6MWT in the Walk 'n Watch group was 163·6 m (112·7) at baseline and 297·2 m (133·2) after 4 weeks. The 6MWT improvement was 43·6 m (95% CI 12·7-76·1) greater in the Walk 'n Watch group than in the usual care group. No serious adverse events occurred during a Walk 'n Watch session. Nine serious adverse events were reported and required admission to acute care (four were recorded in the usual care group and five in the Walk 'n Watch group).
The Walk 'n Watch protocol resulted in a clinically meaningful improvement in walking endurance in patients with subacute stroke in a real-world setting. The protocol can be readily implemented into practice with minimal additional resources. Further research is needed to identify characteristics of patients who might benefit the most from Walk 'n Watch.
Canadian Institutes of Health Research, Canada Brain Research Fund, Michael Smith Health Research BC, Fonds de recherche du Québec-Santé, Canada Research Program, and Heart and Stroke Foundation of Canada.
尽管临床指南支持中风后进行大量步行训练，但实践中改变进展缓慢。我们开展了一项实施试验，以使整个中风单元能够采用“边走边看”结构化渐进式运动方案。我们的目标是评估在住院中风康复环境中，“边走边看”实施包对4周后患者结局的有效性。
这项实用的3期阶梯楔形整群随机对照试验在加拿大7个省的12个地点（住院中风康复单元）进行。每个地点被随机分配（1:1:1:1）到四个过渡序列之一，每个序列有三个地点。各地点根据分配在不同时间从常规护理改为“边走边看”方案。所有一线物理治疗师都接受了实施“边走边看”方案的培训。“边走边看”方案要求每次训练至少完成30分钟与步行相关的活动，并根据心率和步数监测器逐步增加强度。进展情况根据一线物理治疗师作为方案一部分进行的筛查6分钟步行试验（6MWT）来规定。主要终点是随机分组后4周时的步行耐力（6MWT）。盲法评估人员在基线和4周后进行评估。主要分析使用了线性混合效应模型，并对单元规模、层、日历时间、年龄、性别和基线6MWT进行了调整。该试验已在ClinicalTrials.gov注册，注册号为NCT04238260，现已完成。
在2021年6月4日至2024年3月1日期间，我们纳入了12个地点的314名参与者，其中8名在入组后被判定不符合条件，306名被纳入主要分析（常规护理组162名，“边走边看”组144名）。参与者的平均年龄为68岁（标准差13），中风后的平均时间为29天（17），基线6MWT为152米（106）。188名（61%）为男性，118名（39%）为女性。常规护理组的平均6MWT在基线时为137.1米（100.9），4周后为223.6米（130.4）。“边走边看”组的平均6MWT在基线时为163.6米（112.7），4周后为297.2米（133.2）。“边走边看”组的6MWT改善比常规护理组大43.6米（95%置信区间12.7 - 76.1）。在“边走边看”训练期间未发生严重不良事件。报告了9起严重不良事件，需要入住急性护理病房（常规护理组记录4起，“边走边看”组记录5起）。
在现实环境中，“边走边看”方案使亚急性中风患者的步行耐力有了具有临床意义的改善。该方案可以在几乎不增加额外资源的情况下轻松实施到实践中。需要进一步研究以确定可能从“边走边看”方案中获益最大的患者特征。
加拿大卫生研究院、加拿大脑研究基金、不列颠哥伦比亚省迈克尔·史密斯健康研究基金、魁北克健康研究基金、加拿大研究计划以及加拿大心脏与中风基金会。
