Safety and effectiveness of the Walk ‘n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial

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Safety and effectiveness of the Walk ‘n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial

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https://doi.org/10.1016/S1474-4422(25)00201-7Get rights and content

Refers to

Gait training after stroke: are physiotherapists overcautious?

The Lancet Neurology, Volume 24, Issue 8, August 2025, Pages 626-627

Gert Kwakkel

Referred to by

Gait training after stroke: are physiotherapists overcautious?

The Lancet Neurology, Volume 24, Issue 8, August 2025, Pages 626-627

Gert Kwakkel

Summary

Background

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.

Methods

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.

Findings

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).

Interpretation

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.

Funding

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.

Introduction

Annually, there are 12 million new stroke cases worldwide, making stroke one of the leading causes of global disability.1 Regaining walking independence is one of the top priorities listed by people living with stroke, their caregivers, and health professionals.2 Clinical practice guidelines support high repetitions of walking practice to achieve independence in walking after stroke.3 Yet, practice is slow to change with low levels of walking activity in stroke rehabilitation units,4, 5 despite the greatest potential for neuroplasticity within the first few months after the stroke.6

Research in context

Evidence before this study

We searched PubMed with the search terms “stroke” AND “walking” AND “exercise” AND (“inpatient” OR “subacute”) published between Jan 1, 1998, and Jan 1, 2025. We focused on randomised trials that were phase 3 or had sample sizes of at least 100 participants. Furthermore, we selected studies that were pragmatic; ie, that were delivering an intervention in routine clinical practice involving staff with typical experience levels and resources. We excluded papers that used exercise with robotics or neuromodulation. The FIT-Stroke outpatient circuit training trial (n=250 patients involving 60 therapists) found a difference in the 6MWT of 20 m between the intervention and usual care. The CIRCIT trial (n=283 patients involving unit physiotherapists, therapy assistants, and students) found no difference on walking endurance between 4 weeks of standard of care inpatient stroke physiotherapy (5 days per week) and physiotherapy (7 days per week) or a group circuit class (5 days per week). The MOBILISE trial (n=126 non-ambulatory patients involving 25 therapists) found that treadmill walking with bodyweight support resulted in a non-significant increase in the number of people walking independently after stroke. The SIRRACT trial (n=135) found no group differences in walking speed between feedback and encouragement based on step-count sensor data (daily walking steps, distance, and speed) delivered three times a week compared with the control group, which was provided feedback on their 10 m walk distance with the same frequency when implemented into usual inpatient stroke rehabilitation practice.

Added value of this study

The Walk ‘n Watch study is, to our knowledge, the first inpatient phase 3 randomised clinical trial that involved all front-line physical therapists to deliver a structured, progressive protocol that improved walking outcomes after stroke.

Implications of all the available evidence

Less than 5% of clinical trials are done under real-world conditions. In this trial, the Walk ‘n Watch protocol improved(Not returned to normal!) walking endurance in people with subacute stroke within a real-world setting where over 85 therapists delivered the intervention across 12 sites as part of usual care. This pragmatic trial also induced clinically meaningful improvements in walking speed, balance, mobility, and quality of life. The Walk ‘n Watch protocol, consisting of structured progressions based on a screening 6MWT, can be readily implemented into practice with minimal additional resources.

Phase 3 trials have tested whether increased exercise intensity during inpatient stroke rehabilitation can improve walking (eg, LEAPS7 and PHYS-STROKE8 trials had a primary outcome of gait speed). However, few of these trials had a pragmatic design. Pragmatic trials that test the effectiveness of an innovation under usual care conditions, make up less than 5% of clinical trials;9 such designs improve the applicability of the findings and facilitate uptake. The pragmatic FIT-Stroke (n=250 patients involving 60 therapists) found an outpatient circuit training programme resulted in a 20 m between-group difference in the 6-minute walk test (6MWT) compared with usual care.10 The CIRCIT trial (n=283 patients involving unit physiotherapists, therapy assistants, and students) found no between-group differences after 4 weeks between standard of care inpatient stroke physiotherapy 5 days per week versus physiotherapy 7 days per week, or a group circuit class 5 days per week.11 The MOBILISE trial (n=126 non-ambulatory patients involving 25 therapists) found that treadmill walking with bodyweight support resulted in a non-significant increase in the number of people walking independently after stroke.12 A phase 3 study implemented into usual inpatient stroke rehabilitation practice (SIRRACT Trial, n=135) found no improvement in walking speed with thrice weekly feedback and encouragement based on step-count sensor data (daily walking steps, distance, and speed) versus feedback on the 10-m walk test speed.13

In our recent randomised phase 2 trial (DOSE), one experienced, trained therapist (plus a backfill therapist) per site delivered our structured, progressive protocol integrated into daily inpatient physical therapy.14 The protocol (progressive increase in the number of steps completed within 30 min with a target heart rate of 40–60% heart rate reserve) resulted in substantially greater walking activity during therapy and improved walking (60 m on a 6MWT) and quality-of-life measures compared with usual care after 4 weeks of inpatient rehabilitation.14 Many barriers to implementing higher intensity protocols exist early after stroke.15 An intervention that is effective in real-world settings will have widespread generalisability for stroke units, providers who deliver the intervention, and patients who receive the intervention. Thus, we undertook a pragmatic implementation trial to change routine practice using a stepped-wedge cluster-randomised design to control when stroke units (randomised into sequences) were exposed to the intervention. We modified the DOSE protocol and renamed it the Walk ‘n Watch protocol. One of the key protocol differences is that the DOSE trial screened every participant with a physician-led, ECG-monitored graded exercise stress test. To reduce the burden on resources, the Walk ‘n Watch protocol utilised a 6MWT by the treating physical therapist as the safety screen, and used the distance achieved on the 6MWT as a basis for individualising the targets for steps taken in the physical therapy sessions. Our objective was to evaluate the effectiveness of the Walk ‘n Watch implementation package, in an inpatient stroke rehabilitation setting, on walking endurance after 4 weeks in patients with subacute stroke.

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