Effect of very early mobilisation on functional status in patients with acute stroke: a single-blind, randomized controlled trail

Chippala, Purusotham; Sharma, Raghava

doi:10.1177/0269215515596054

Cited by 56 publications

(53 citation statements)

References 14 publications

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“…Results are presented as the OR (95% CI) of the early versus delayed mobilisation group. 65 Bernhardt 35 AVERT 31 Chippala 60 Chippala 63 Poletto 61 Herisson 62 T his project met its initial objectives of effectively delivering our VEM protocol with a resulting change in practice. 30 We observed earlier, more frequent and higher dose (amount of) out-of-bed mobility in terms of sitting, standing and walking activity.…”

Section: Statistical Trial Resultsmentioning

confidence: 99%

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A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Langhorne

Rodgers

et al. 2017

Health Technol Assess

128

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BackgroundMobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit.ObjectivesWe assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.DesignWe conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.SettingThe trial took place in 56 acute stroke units in five countries.ParticipantsWe included adult patients with a first or recurrent stroke who met physiological inclusion criteria.InterventionsPatients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.Main outcome measuresThe primary outcome was good recovery [modified Rankin scale (mRS) score of 0–2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose–response analysis.Data sourcesPatients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.ResultsWe recruited 2104 (UK,n = 610; Australasia,n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours;p < 0.0001] earlier, with an additional three (95% CI 3.0 to 3.5;p < 0.0001) mobilisation sessions per day. Fewer patients in the VEM group (n = 480, 46%) had a favourable outcome than in the UC group (n = 525, 50%) (adjusted odds ratio 0.73, 95% CI 0.59 to 0.90;p = 0.004). Results were consistent between Australasian and UK settings. There were no statistically significant differences in secondary outcomes at 3 months and QoL at 12 months. Dose–response analysis found a consistent pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day).LimitationsUC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction.ConclusionsPatients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable outcome at 3 months cautioning against very early high-dose mobilisation. At 12 months, health-related QoL was similar regardless of group. Shorter, more frequent mobilisation early after stroke may be associated with a more favourable outcome.Future workThese results informed a new trial proposal [A Very Early Rehabilitation Trial – DOSE (AVERT–DOSE)] aiming to determine the optimal frequency and dose of EM.Trial registrationThe trial is registered with the Australian New Zealand Clinical Trials Registry number ACTRN12606000185561, Current Controlled Trials ISRCTN98129255 and ISRCTN98129255.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 54. See the NIHR Journals Library website for further project information. Funding was also received from the National Health and Medical Research Council Australia, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, and the Stroke Association. In addition, National Health and Medical Research Council fellowship funding was provided to Julie Bernhardt (1058635), who also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation (G04M1571). The Florey Institute of Neuroscience and Mental Health, which hosted the trial, acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.

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Section: Statistical Trial Resultsmentioning

confidence: 99%

“…In our systematic review of similar RCTs, we identified eight eligible trials 25,27,31,[60][61][62][63][64] that currently have data available. Of these eight trials (2618 participants), AVERT provided the most information (2104 participants).…”

Section: Meta-analysis Of Early Mobilisation Trialsmentioning

confidence: 99%

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Langhorne

Rodgers

et al. 2017

Health Technol Assess

128

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“…Chippala et al [51] used a VEM protocol modeled after AVERT’s, with 5–30-min sessions of OOB activity at least twice a day for 7 days, beginning within 24 h of stroke onset, in addition to SC (defined as 45 min a day of passive and/or active exercises, with mobilization occurring at the therapists’ discretion). The primary outcome was change in functional status (Barthel Index [BI]) from baseline to hospital discharge.…”

Section: Human Trialsmentioning

confidence: 99%

Early Rehabilitation After Stroke: a Narrative Review

Coleman

Moudgal

Lang

et al. 2017

Curr Atheroscler Rep

274

195

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Purpose of Review Despite current rehabilitative strategies, stroke remains a leading cause of disability in the USA. There is a window of enhanced neuroplasticity early after stroke, during which the brain’s dynamic response to injury is heightened and rehabilitation might be particularly effective. This review summarizes the evidence of the existence of this plastic window, and the evidence regarding safety and efficacy of early rehabilitative strategies for several stroke domain-specific deficits. Recent Findings Overall, trials of rehabilitation in the first 2 weeks after stroke are scarce. In the realm of very early mobilization, one large and one small trial found potential harm from mobilizing patients within the first 24 h after stroke, and only one small trial found benefit in doing so. For the upper extremity, constraint-induced movement therapy appears to have benefit when started within 2 weeks of stroke. Evidence for non-invasive brain stimulation in the acute period remains scant and inconclusive. For aphasia, the evidence is mixed, but intensive early therapy might be of benefit for patients with severe aphasia. Mirror therapy begun early after stroke shows promise for the alleviation of neglect. Novel approaches to treating dysphagia early after stroke appear promising, but the high rate of spontaneous improvement makes their benefit difficult to gauge. Summary The optimal time to begin rehabilitation after a stroke remains unsettled, though the evidence is mounting that for at least some deficits, initiation of rehabilitative strategies within the first 2 weeks of stroke is beneficial. Commencing intensive therapy in the first 24 h may be harmful.

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“…6 The evidence-base behind some of these recommendations is not large, but there is some evidence supporting the involvement of rehabilitation in parallel with medical care. The benefits of early mobilization after acute-onset disability [7][8][9][10] and the risks of bed-rest and immobility are well established. There remains uncertainty whether 'aggressive' mobilization very early after stroke is beneficial.…”

Section: Rehabilitation As a Parallel Servicementioning

confidence: 99%

Rehabilitation – a new approach. Part four: a new paradigm, and its implications

Wade¹

2015

Clin Rehabil

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This editorial proposes changes in healthcare services that should greatly improve the health status of all patients with disability. The main premises are that: rehabilitation usually involves many actions delivered by many people from different organisations over a prolonged period; specific rehabilitation actions cover a wide range of professional activities, with face to face therapy only being one; and the primary patient activity that improves function is practice of personally relevant activities in a safe environment. This editorial argues that: rehabilitation should occur at all times and in all settings, in parallel with medical care in order to maximise recovery and to avoid loss of fitness, skills and confidence associated with rest and being cared for; hospitals and other healthcare settings should adapt the environment to encourage practice of activities at all times; and that measuring rehabilitation, whether in research or for re-imbursement, should not simply consider face-to-face 'therapy time' but must include: all the other important activities undertaken by the team; 'structures' such as the appropriateness of the environment; and a process measure of the time spent by patients undertaking activities.

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Effect of very early mobilisation on functional status in patients with acute stroke: a single-blind, randomized controlled trail

Abstract: The results indicate that very early mobilisation in addition to the standard care may be effective in improving the functional status following acute stroke.

Cited by 56 publications

References 14 publications

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Early Rehabilitation After Stroke: a Narrative Review

Rehabilitation – a new approach. Part four: a new paradigm, and its implications

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