ArticlePDF AvailableLiterature Review

Where to now? AVERT answered an important question, but raised many more

August 2017
International Journal of Stroke 12(7):1747493017727338

DOI:10.1177/1747493017727338

Authors:

Mark Bayley

Toronto Rehabilitation Institute

Coralie Kym English

University of Newcastle Australia

Robert Teasell

Lawson Health Research Institute and western university

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A Very Early Rehabilitation Trial (AVERT) was a Phase 3 randomized trial with over 2100 subjects post stroke that had unexpected results with better outcomes for usual care than those receiving very early mobilization. This review of published stroke clinical practice guidelines highlights that recommendations for mobilization have changed after publication of AVERT but also that developers have struggled to provide recommendations for appropriate dose, duration and intensity of mobilization in the acute post stroke period with available analyses from AVERT and other literature. This review highlights the priority research questions about early rehabilitation post stroke that need to be addressed through future large scale randomized controlled trials.

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Leading Opinion

Where to now? AVERT answered

an important question, but raised

many more

Mark T Bayley

1,2

, Audrey Bowen

, Coralie English

Robert Teasell

and Janice J Eng

Abstract

A Very Early Rehabilitation Trial (AVERT) was a Phase 3 randomized trial with over 2100 subjects post stroke that had

unexpected results with better outcomes for usual care than those receiving very early mobilization. This review of

published stroke clinical practice guidelines highlights that recommendations for mobilization have changed after pub-

lication of AVERT but also that developers have struggled to provide recommendations for appropriate dose, duration

and intensity of mobilization in the acute post stroke period with available analyses from AVERTand other literature. This

review highlights the priority research questions about early rehabilitation post stroke that need to be addressed through

future large scale randomized controlled trials.

Keywords

Acute stroke, rehabilitation, research priorities, clinical practice guidelines

Received: 7 March 2017; accepted: 10 July 2017

A Very Early Rehabilitation Trial (AVERT) was a

Phase 3 randomized trial with over 2100 subjects

designed to end the controversy about the early mobil-

ization of stroke patients.

Undoubtedly, this successful

trial answered an important clinical question. Here we

highlight common challenges that international clinical

guideline writers in Canada, the USA, and UK

(excluding Scotland which has yet to update its guide-

line) have faced interpreting the complexity of the

AVERT results and the questions that remain about

Very Early Mobilization (VEM).

AVERT’s results, demonstrating better outcomes for

usual care over VEM, were unexpected because early

phase studies had raised hopes for the beneﬁts of

VEM. Animal research suggested there was a time

window in the ﬁrst few days when brain is ‘‘primed’’

for maximal response to rehabilitation therapies.

2–4

Cohort studies and secondary analyses from rando-

mized trials found associations between earlier mobiliza-

tion and better outcomes.

5,6

Furthermore, AVERT

Phase 2 (n ¼71) suggested that VEM (median time

18 h vs. 31 h in standard care group) was feasible and

safe to deliver and associated with a promising, albeit

non-signiﬁcant, diﬀerence in disability at 3 months.

7,8

In contrast, a meta-analysis of 159 patients from three

randomized controlled trials (including AVERT Phase

2) found VEM within 24 h trended towards greater mor-

tality (odds ratio 2.58; 95% conﬁdence interval 0.98 to

6.79, P ¼0.06), with no diﬀerences in complications or

health outcomes.

Clearly, the adequately powered

AVERT was necessary to address these issues.

In the deﬁnitive AVERT, the VEM group mobilized

earlier post stroke onset (18.5 vs. 22.4 h) had more out

of bed sessions (6.5 vs. 3.0) and more therapy in the ﬁrst

two weeks (31 min/day: total 201 min vs. 10 min/day:

total 70 min); however, the usual care group had a

greater chance of favorable outcomes (Modiﬁed

Division of Physical Medicine and Rehabilitation, Department of

Medicine, University of Toronto, Toronto, Canada

Toronto Rehabilitation Institute-University Health Network, Toronto,

Canada

Division of Neuroscience and Experimental Psychology, University of

Manchester MAHSC, Manchester, UK

School of Health Sciences and Priority Research Centre for Stroke and

Brain Injury, Hunter Medical Research Institute, University of Newcastle,

Callaghan, Australia

Lawson Health Research Institute, Western University, London, Canada

Department of Physical Therapy, University of British Columbia and GF

Strong Rehab Centre, Vancouver, Canada

Corresponding author:

Mark Bayley, University of Toronto, 550 University Avenue, Toronto

M5G2A2, Canada.

Email: mark.bayley@uhn.ca

International Journal of Stroke, 12(7)

International Journal of Stroke

2017, Vol. 12(7) 683–686

!2017 World Stroke Organization

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DOI: 10.1177/1747493017727338

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Table 1. Overview of international guidelines for early mobilization post stroke.

Developer

(Country, Date) Recommendations for early mobilization

National Institute of Clinical

Excellence U.K. 2008

1.7 Early mobilization and optimum positioning of people with acute stroke. Early mobilization is

considered a key element of acute stroke care. Sitting up will help to maintain oxygen sat-

uration and reduce the likelihood of hypostatic pneumonia.

1.7.1.1 People with acute stroke should be mobilized as soon as possible (when their clinical

condition permits) as part of an active management program in a specialist stroke unit.

1.7.1.2 People with acute stroke should be helped to sit up as soon as possible (when their

clinical condition permits).

Behandling og rehabilitering

ved hjerneslag

National guidelines for treat-

ment and rehabilitation

by stroke

(Norway, 2010)

All stroke patients should quickly be mobilized out of bed, and all of the interdisciplinary team B

(level 2a) should contribute to mobilize patients as early and as often as possible.

It has been common clinical practice to await mobilization when systolic BP >220 mmHg or

severe dizziness. In these cases, it is recommended to measure BP lying and sitting, and to

cancel mobilization for SBP-decrease of >30 mmHg and concurrent symptoms. Patients

treated with beta-blockers and/or who have hypovolemia should be monitored especially

carefully.

Mobilization consists of the patient returns to a sitting, standing, or walking position, depending

on the functional level. All members of the multidisciplinary team will help the patient be

mobilized as early and as often as possible. Mobilization must be conducted 00:10 day 7

days a week (175; 223; 224) (Level 2a)

Scottish Intercollegiate

(2011)

Stroke patients should be mobilized as early as possible after stroke (Level B).

European Stroke

Organization 2013

1. Early mobilization of the patient according to out of bed within 24-h principle as soon as the

stroke has stabilized and the general medical condition and stroke severity make this possible.

2. Early mobilization and physical therapy at least once daily (7/7) and, if resources make it

possible, preferably twice a day, adapted to the medical condition of the patient.

A World Stroke Organization

2014

16,17

All patients admitted to hospital with acute stroke should start to be mobilized early (between

24 and 48 h of stroke onset) if there are no contraindications

Contraindications to early mobilization include, but are not restricted to, patients who have had an

arterial puncture for an interventional procedure, unstable medical conditions, low oxygen satur-

ation, and lower limb fracture or injury.

Nursing Research Institute

Stroke Coalition

February 2015

Early mobilization: Within the first 24 h for neurologically and hemodynamically stable patients is

safe and feasible (class IIa: level of evidence B).

Early mobilization (within 52 h) is associated with fewer complications. Patients with stable

neurological and hemodynamic presentation can be mobilized to out of bed chair sitting

even if level of consciousness is depressed (i.e. stupor, obtundation, and lethargy; class IIa:

level of evidence C)

April 2015 Post-AVERT recommendations for early mobilization

Heart and Stroke Foundation

Canada 2016

i. All patients with stroke should receive rehabilitation therapy as early as possible once they are

determined to be rehabilitation ready and they are medically able to participate in active

rehabilitation (Level A) within an active and complex stimulating environment (Level C).

ii. Frequent, out-of-bed activity in the very early time frame (within 24 h of stroke onset) is not

recommended (Evidence Level B). Mobilization may be reasonable for some patients with acute

stroke in the very early time frame and clinical judgment should be used (Evidence Level C).

All patients admitted to hospital with acute stroke should start to be mobilized early (between 24

and 48 h of stroke onset) if there are no contraindications (Evidence Level B).

Contraindications to early mobilization include, but are not restricted to, patients who have

had an arterial puncture for an interventional procedure, unstable medical conditions, low

oxygen saturation, and lower limb fracture or injury.

(continued)

International Journal of Stroke, 12(7)

684 International Journal of Stroke 12(7)

Rankin Score 0–2) at three months (adjusted odds ratio

0.73, 95% CI 0.59–0.90, p ¼0.004). The strength of

prior belief in VEM was such that during the course

of AVERT usual care changed; median time to ﬁrst

mobilization shrank from 31 to 22.4 h.

Subgroup and dose response analyses provided some

biologically plausible hypotheses into non-signiﬁcant

diﬀering response patterns to VEM. Although the

AVERT team rightly caution against over-interpretation

of these additional analyses, they highlight unanswered

questions for future research.

Does more frequent

mobilization really improve the odds of a favorable out-

come by 13% and walking 50m unassisted by 66%

when time and daily amount are kept constant? Does

increased minutes/day really worsen chances of a good

outcome? The Head Position in Stroke Trial

(HEADPost) found upright posture in ﬁrst 24h did

not worsen outcomes, so how does increasing the

amount of time spent in out of bed activity reduce the

chance of good outcomes?

To what extent are these

ﬁndings driven by participants with greater stroke sever-

ity or hemorrhagic stroke?

So what is the optimal mobilization strategy in the

acute stroke period? Table 1 summarizes the recom-

mendations for VEM from international guidelines.

One can observe the impact of the high quality evi-

dence from AVERT, a marked change from recom-

mending mobilization as early as possible post stroke

prior to AVERT’s publication, to recommending not

to do so after 2015. The Norwegian and Australian

guidelines are expected later this year; it will be inter-

esting to consider how they incorporate AVERT’s

ﬁndings.

The US, UK, and Canadian guideline recommenda-

tions are remarkably similar despite the diﬀerent grades

of strength of the evidence due to the diﬀerent meth-

odologies. The consistent message is that they no longer

recommend mobilization within the ﬁrst 24 h, with

some exceptions, e.g. the UK recommends those who

require little or no assistance are mobilized within 24 h

(they were excluded from AVERT) and the Canadian

guideline states that mobilization may be reasonable for

some patients with acute stroke in the very early time-

frame. There is admittedly a lack of information on

what is meant by ‘‘high dose VEM’’ and the optimal

frequency and duration of mobilizations. More precise

recommendations cannot be provided without further

research.

There is a critical need to address the remaining

research questions. The priority questions are: (1)

What is the optimal dose in minutes of VEM in dur-

ation and frequency? (2) How intense should the exer-

tion be? (3) How should we design trials that compare

diﬀerent speciﬁed doses for diﬀerent subgroups?

AVERT Phase 3 demonstrated that it was feasible to

conduct large, early rehabilitation trials of complex

interventions and aﬃrms that we should accept with

extreme caution lower forms of evidence, e.g. observa-

tional studies and small RCTs. It is time for the inter-

national stroke community to work together to provide

these critical answers.

Declaration of conflicting interests

The author(s) declared no potential conﬂicts of interest with

respect to the research, authorship, and/or publication of this

article.

Table 1. Continued

Developer

(Country, Date) Recommendations for early mobilization

American Heart Association/

American Stroke

Association (US, 2016)

It is recommended that stroke survivors receive rehabilitation at intensity commensurate

with anticipated benefit and tolerance. (Level B)

High-dose, ver y early mobilization within 24 h of stroke onset can reduce the odds of a

favorable outcome at 3 months and is not recommended (Level A)

Intercollegiate Stroke

Working Party, Royal

College of Physicians

London

(UK 2016)

Patients with difficulty moving after stroke should be assessed as soon as possible within the

first 24 h of onset by an appropriately trained healthcare professional to determine the most

appropriate and safe methods of transfer and mobilization.

Patients with difficulty moving early after stroke who are medically stable should be offered

frequent, short daily mobilizations (sitting out of bed, standing, or walking) by appropriately

trained staff with access to appropriate equipment, typically beginning between 24 and 48 h of

stroke onset. Mobilization within 24 h of onset should only be for patients who require little

or no assistance to mobilize.

Australian guidelines Due to be released in 2017

Norwegian guidelines Due to be released in September 2017

International Journal of Stroke, 12(7)

Bayley et al. 685

Funding

The author(s) disclosed receipt of the following ﬁnancial sup-

port for the research, authorship, and/or publication of this

article: Mark Bayley was partly funded by the Toronto

Rehabilitation Institute Foundation Saunderson Family

Chair in Acquired Brain injury Research. Audrey Bowen

was partly funded by the National Institute for Health

Research Collaboration for Leadership in Applied Health

Research and Care (NIHR CLAHRC) Greater Manchester

and Stroke Association. Janice Eng was supported by the

Canada Research Chair Program. The funders had no role

in the decision to publish or preparation of the manuscript

however, this article may be considered to be aﬃliated to the

work of the NIHR CLAHRC Greater Manchester. The views

expressed in this article are those of the authors and not

necessarily those of the NHS, NIHR, Department of Health

or Stroke Association, Canada Research Chairs program or

Toronto Rehabilitation Institute.

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Clinical and systems of care factors contributing to individual patient decision-making for early mobilization post-stroke

Article

Full-text available

Dec 2023

Introduction Many stroke guidelines recommend against starting intensive out-of-bed activity (mobilization) within 24 h post-stroke. Few guidelines address care after the first 24–48 h, and little information is provided about how early mobilization decisions should be tailored to patients. We aimed to identify clinical and systems of care factors contributing to individual patient decision-making for early mobilization post-stroke. Methods Expert stroke clinicians were recruited to participate in an interactive one-on-one session that included an introductory semi-structured interview followed by an assisted data exploration session using an early mobilization data visualization tool. Results Thirty expert stroke clinicians with a median (interquartile range) 14 (10–25) years of experience were included. Stroke type and severity, and medical stability were identified as important clinical decision-making factors by the majority of expert stroke clinicians. Inadequate staffing and equipment were frequently indicated as barriers to early mobilization. The perceived characteristics of early mobilization responders were mild or moderate stroke severity, ischemic stroke, partial anterior circulation stroke, younger age, and one or fewer comorbidities. Perceived characteristics of early mobilization non-responders included severe stroke severity, hemorrhagic stroke, total anterior circulation stroke, older age, those with persistent vessel occlusion or high-grade stenosis, hemodynamic instability, multimorbidity and an altered state of consciousness. Some characteristics led to uncertainty amongst interviewees e.g., early mobilization decision-making were moderate stroke severity, older patients, and those with lacunar circulation infarcts. Discussion We gained unique, in-depth insights into patient and systems of care factors that contribute to individual patient decision-making related to early mobilization post-stroke. The identified areas would benefit from further empirical research to develop structured decision support for clinicians.

Early Mobilization After Stroke: Do Clinical Practice Guidelines Support Clinicians' Decision-Making?

Article

Full-text available

Feb 2021

Importance: Early mobilization, out-of-bed activity, is a component of acute stroke unit care; however, stroke patient heterogeneity requires complex decision-making. Clinically credible and applicable CPGs are needed to support and optimize the delivery of care. In this study, we are specifically exploring the role of clinical practice guidelines to support individual patient-level decision-making by stroke clinicians about early mobilization post-stroke. Methods: Our study uses a novel, two-pronged approach. (1) A review of CPGs containing recommendations for early mobilization practices published after 2015 was appraised using purposely selected items from the Appraisal of Guidelines Research and Evaluation–Recommendations Excellence (AGREE-REX) tool relevant to decision-making for clinicians. (2) A cross-sectional study involving semi-structured interviews with Australian expert stroke clinicians representing content experts and CPG target users. Every CPG was independently assessed against the AGREE-REX standard by two reviewers. Expert stroke clinicians, invited via email, were recruited between June 2019 to March 2020.The main outcomes from the review was the proportion of criteria addressed for each AGREE-REX item by individual and all CPG(s). The main cross-sectional outcomes were the distributions of stroke clinicians' responses about the utility of CPGs, specific areas of uncertainty in early mobilization decision-making, and suggested parameters for inclusion in future early mobilization CPGs. Results: In 18 identified CPGs, many did not adequately address the “Evidence” and “Applicability to Patients” AGREE-REX items. Out of 30 expert stroke clinicians (11 physicians [37%], 11 physiotherapists [37%], 8 nurses [26%]; median [IQR] years of experience, 14 [10–25]), 47% found current CPGs “too broad or vague,” while 40% rely on individual clinical judgement and interpretation of the evidence to select an evidence-based choice of action. The areas of uncertainty in decision-making revealed four key suggestions: (1) more granular descriptions of patient and stroke characteristics for appropriate tailoring of decisions, (2) clear statements about when clinical flexibility is appropriate, (3) detailed description of the intervention dose, and (4) physical assessment criteria including safety parameters. Conclusions: The lack of specificity, clinical applicability, and adaptability of current CPGs to effectively respond to the heterogeneous clinical stroke context has provided a clear direction for improvement.

Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke

Article

Nov 2020
NEUROLOGY

Objective: This tertiary analysis from AVERT examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days. Method: AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours post stroke, termed very early mobilization (VEM) to usual care (UC). Primary outcome was assessed at 3 months. Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset. Treatment with thrombolytics allowed. Excluded: Patients with severe premorbid disability and/or comorbidities. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were non-fatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIHSS) and age. Results: 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (IQR 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted Odds Ratio of 1.76 (95% CI 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral haemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in non-fatal SAEs found. Conclusion: While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care. Stroke progression was more common in VEM. Classification of evidence: This study provides Class I evidence that very early mobilization increases mortality at 14 days post stroke. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.

Dr. Nikhil Kumar Sahu et al/Title-Effect of early mobilization in mild and moderate intracerebral bleed patients Title-Effect of early mobilization in mild and moderate intracerebral bleed patients. [1] Dr

Article

Full-text available

Dec 2024

Background. Intracranial hemorrhage (ICH) is acritical and often life-threatening condition characterized by bleeding within the intracranial vault, including the brain parenchyma and surrounding meningeal spaces. Earlymobilizationwas defined as early out-of-bed activities of daily living (ADLs), based on the concepts of very early mobilizationin stroke patients 3 and associated enhanced functional outcomes. Few studies have addressed early out-of-bed mobilization specifically in acute intracerebral hemorrhage (ICH) patients. Patient benefit in such cases is unclear, with early intervention timing and duration identical to those in standard care. Aims and Objective. This is a prospective, observational, single center study done in Department of neurology GSVM medical college hospital Kanpur in 60 patients of mild to moderate intracerebral bleed patients: 1 st March.2022 to 1 st march 2024. The main aim of this study is 'Effect of early mobilization in mild and moderate intracerebral bleed patients. We investigated the efficacy of an early mobilization (EM) protocol, administered within 24 to 72 hours of stroke onset, for early functional independence in mild-moderate ICH patients. Methods .In this study Sixty patients admitted to a stroke center with in 24 hours of ICH were randomly assigned to early mobilization (EM) or standard early rehabilitation (SER). The EM group under went an early out-of-bed mobilization protocol, whiletheSERgroupunderwentastandardprotocolfocusingonin-bedtraining in the stroke center. Intervention in bothgroupslasted30minutespersession,oncea day, 5 days a week. Motor subscales of the Functional Independence Measure (FIM-motor), Postural Assessment Scale for Stroke Patients, and Functional Ambulation Category (FAC) were evaluated (assessor-blinded) at base line, and at 2weeks, 4weeks, and 3 months after stroke. Length ofstayin the stroke enter was also recorded. Dr. Nikhil Kumar Sahu et al/Title-Effect of early mobilization in mild and moderate intracerebral bleed patients eISSN1303-5150 www.neuroquantology.com Results. mean time to first mobilization aftersymptom onset was 51.60 hours in the EM group and 135. 02 hours in the SER group (P <.001). At baseline, the 2 groups weresimilar regarding age, height, weight, gender, hematomavolume, stroke site, lesion location, initial NIHSS score,NIHSSupper-extremity and lower-extremity subscalescores, ICH score at admission, initial FIM-motor score, PASSscore, and FAC level. In addition, the mediannumberof treatment sessions per group during the acute phase was similar: EM 7.0 (range 2-18) versus SER 6.5 (range 2-19)(P = .988 between groups). The EM group showed significant improvement in FIM-motor score at all evaluated time points (P=.004) and in FAC outcomes at 2 weeks (P = .033) and 4 weeks (P = .011) after stroke. Length of stay in the stroke center was significantly shorter for the EM group(P=.004). Conclusion-earlymobilizationinastrokecenterwithin24 to 72 hours of stroke onset, specifically in patients with mild or mild-moderateI CH, andusinganEM protocol with standard intervention time and session frequency, may be more effective than standard early rehabilitation in achievingfunctionalindependencewithin3monthsofstroke.

Can Early Neuromuscular Rehabilitation Protocol Improve Disability after a Hemiparetic Stroke? A Pilot Study

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Jun 2022
BSRCCS

Background: The impairment of limb function and disability are among the most im portant consequences of stroke. To date, however, little research has been done on the early reha bilitation trial (ERT) after stroke in these patients. The purpose of this study was to evaluate the impact of ERT neuromuscular protocol on motor function soon after hemiparetic stroke. The sample included twelve hemiparetic patients (54.3 ± 15.4 years old) with ischemic stroke (n = 7 control, n = 5 intervention patients). ERTwas started as early as possible after stroke and included passive range of motion exercises, resistance training, assisted standing up, and active exercises of the healthy side of the body, in addition to encouraging voluntary contraction of affected limbs as much as possible. The rehabilitation was progressive and took 3 months, 6 days per week, 2–3 h per session. Fu gle-Meyer Assessment (FMA), Box and Blocks test (BBT) and Timed up and go (TUG) assessments were conducted. There was a significantly greater improvement in the intervention group com pared to control: FMA lower limbs (p = 0.001), total motor function (p = 0.002), but no significant difference in FMA upper limb between groups (p = 0.51). The analysis of data related to BBT showed no significant differences between the experimental and control groups (p = 0.3). However, TUG test showed significant differences between the experimental and control groups (p = 0.004). The most important finding of this study was to spend enough time in training sessions and provide adequate rest time for each person. Our results showed that ERT was associated with improved motor function but not with the upper limbs. This provides a basis for a definitive trial.

“Hyperacute” Stroke Rehabilitation Care: Common Issues and Considerations

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Dec 2020

Purpose of review We provide a comprehensive review of current issues and treatment guidelines for stroke rehabilitation in the acute care setting. Recent findings Neuroplasticity and stroke recovery have been found to start at the onset of injury. As a result, neurorehabilitation beginning in the acute care setting has emerged as a promising management strategy to improve patient outcomes and quality of life. Specific treatment and rehabilitation protocols in the acute recovery phase include those that target motor recovery, spasticity, cognitive processes, nutrition, communication, and family dynamics. Summary Stroke is currently the leading cause of adult disability in the USA and a prominent cause of death. When considering the aging population, it is clear that this disease will continue to grow in its economic, social, and personal costs over the coming years. Given the increasing knowledge on the neurobiology of stroke recovery, there has been an emerging role for early neurorehabilitation in the acute inpatient stroke setting. Many multidisciplinary early rehabilitation interventions have shown to improve patient outcomes; however, additional research is required to optimize patient care for patients with different stroke subtypes and varying degrees of illness severity.

Early Mobilization of Mild-Moderate Intracerebral Hemorrhage Patients in a Stroke Center: A Randomized Controlled Trial

Article

Dec 2019

Background. Few studies have addressed early out-of-bed mobilization specifically in acute intracerebral hemorrhage (ICH) patients. Patient benefit in such cases is unclear, with early intervention timing and duration identical to those in standard care. Objective. We investigated the efficacy of an early mobilization (EM) protocol, administered within 24 to 72 hours of stroke onset, for early functional independence in mild-moderate ICH patients. Methods. Sixty patients admitted to a stroke center within 24 hours of ICH were randomly assigned to early mobilization (EM) or standard early rehabilitation (SER). The EM group underwent an early out-of-bed mobilization protocol, while the SER group underwent a standard protocol focusing on in-bed training in the stroke center. Intervention in both groups lasted 30 minutes per session, once a day, 5 days a week. Motor subscales of the Functional Independence Measure (FIM-motor; primary outcome), Postural Assessment Scale for Stroke Patients, and Functional Ambulation Category (FAC) were evaluated (assessor-blinded) at baseline, and at 2 weeks, 4 weeks, and 3 months after stroke. Length of stay in the stroke center was also recorded. Results. The EM group showed significant improvement in FIM-motor score at all evaluated time points ( P = .004) and in FAC outcomes at 2 weeks ( P = .033) and 4 weeks ( P = .011) after stroke. Length of stay in the stroke center was significantly shorter for the EM group ( P = .004). Conclusion. Early out-of-bed mobilization via rehabilitation in a stroke center, within 24 to 72 hours of ICH, may improve early functional independence compared with standard early rehabilitation. Clinical Trial Registration: NCT03292211.

A Novel Mobilization Criteria Checklist 12 to 24 Hours After Intravenous Thrombolysis in Acute Ischemic Stroke

Article

Jul 2022

Purpose This study describes the development and utilization of a novel mobilization criteria checklist that can guide clinical decision making to safely initiate very early mobilization for patients with acute ischemic stroke within 12 to 24 hours after intravenous (IV) thrombolysis. Methods The evidence was examined, and risk factors for hemorrhagic transformation and considerations for initiating or terminating mobility within the first 12 to 24 hours were identified. The information was formatted into a mobilization criteria checklist for use in a case study 12 to 24 hours after tissue plasminogen activator (tPA), an IV thrombolytic, was given for acute ischemic stroke at a certified comprehensive stroke center. Outcomes The tool was an additive to clinical practice and provided a clinical guide to optimize patient safety for an established institutional practice. Discussion A mobilization criteria checklist is a helpful tool to screen for serious risk factors of hemorrhagic transformation in the first 24 hours after IV thrombolysis for acute ischemic stroke. With further development, the foundational concepts may guide future research to establish clinical practice guidelines and a standard of care to optimize the selection of patients most appropriate for mobility within 12 to 24 hours.

Very early mobilization in the stroke unit: Functionality, quality of life and disability at 90 days and 1 year post-stroke

Article

Jul 2021
NEUROREHABILITATION

Background: The evidence of early mobilization after stroke is conflicting, and the recovery period is an important concern. Objective: To analyse the functionality, quality of life and disability at 90 days and 1 year post-stroke of patients who received a Very Early Mobilization Protocol (VEMP). Methods: Prospective cohort study in a tertiary stroke unit. Consecutive patients aged≥18 years and without prior significant disability, who presented motor deficit after acute stroke, were included. A symmetry test was performed to compare the changes in the main variables: Barthel Index (BI), Functional Ambulation Category (FAC), modified Rankin Scale (mRS) and EuroQol five-dimensions three-level (EQ-5D-3L) between 90 days and 1 year post-stroke. Results: A total of 123 patients were recruited. The BI reflected an improvement at 1 year in transfer to chair/bed in 25.8%(p < 0.01) of patients and in toilet use in 25.8%(p = 0.02). The FAC showed an improvement at 1 year in 44.4%(p < 0.01) of patients and the mRS in 19.1%(p = 0.01). The usual activities dimension of the EQ-5D-3L showed a clinically relevant improvement after 1 year in 15.9%(p = 0.23) of patients. Conclusions: A significant percentage of patients show improvements in some functional areas and in disability between 90 days and 1 year post-stroke.

Mobilization for Persons With Acute Stroke: A Survey of Current Physical Therapy Clinical Practice

Article

Dec 2019

Purpose To examine reported practice patterns of physical therapists (PTs) related to mobilization of persons with acute stroke. The researchers hypothesized that (1) facilities certified as primary stroke centers by The Joint Commission (TJC) will mobilize persons with acute stroke 24 hours or less after symptom onset; (2) persons with fewer impairments following acute stroke and those with ischemic stroke, who did not receive tissue plasminogen activator (tPA), are mobilized sooner; (3) PTs are the first to mobilize among interdisciplinary team members; and (4) PTs with more experience will mobilize sooner than novice PTs. Methods Survey Development: All members of the research team independently searched and reviewed the current literature describing the timing of initial mobilization after stroke. A pilot survey was developed from themes in the literature emphasizing areas hypothesized. Once the feedback from the pilot survey was reviewed, the survey was finalized and converted to an online survey using SurveyMonkey. Survey Implementation and Analysis: The target audience for the survey was PTs who treat persons with acute stroke. “Acute stroke,” for this survey, was defined as a stroke less than 1 week from onset of stroke symptoms. Potential respondents were contacted via e-mail through the APTA acute care and neurologic listservs. The survey contained 26 questions related to participant demographics, the timing and frequency of mobilization for persons with acute stroke based on defined impairment levels, perceptions about influences on mobilization, and knowledge of current related evidence. Descriptive result statistics were generated by SurveyMonkey. One-way analysis of variance was used to compare responses by practice setting, degree, APTA membership, and specialist certification. Spearman's rank correlation was used to correlate results based on participant characteristics. Results A total of 161 PTs participated with a mean of 15 years' clinical practice. Most (67%) of the respondents report mobilizing persons with minimal impairment and uncomplicated ischemic stroke, not treated with tPA, in 24 hours or less. PTs were identified as the first to mobilize persons after stroke with severe (95%) and moderate impairments (91%). Recipients of tPA, persons with severe impairment, and those who received neurosurgical intervention were initially mobilized between 25 and 48 hours majority of the time. PTs working for a TJC stroke-certified institution did not mobilize sooner. The number of years of PT experience had a weak negative correlation to the timing of mobilization. Most respondents (58%) reported that mobilization more than 2 times per day is optimal. The barriers to more frequent mobilization included increased caseload, lack of resources, and lack of interdisciplinary patient care coordination. Conclusions The frequency of mobilization reported in this survey is less than proposed by the results of the most recent “A Very Early Rehabilitation Trial” (AVERT) after stroke, phase 3 trial. This study found a positive correlation between increased session frequency and recovery of walking at 3 months, survival, and a modified Rankin Scale (mRS) score of 2 or less. Respondents believe additional mobilization would be beneficial, but report barriers to implementation that include increased PT caseloads and lack of resources. Additional research is required to determine the influence of mobilization timing and frequency on patient outcomes such as the degree of disability after stroke.

Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015

Article

Full-text available

Apr 2016

Stroke rehabilitation is a progressive, dynamic, goal-orientated process aimed at enabling a person with impairment to reach their optimal physical, cognitive, emotional, communicative, social and/or functional activity level. After a stroke, patients often continue to require rehabilitation for persistent deficits related to spasticity, upper and lower extremity dysfunction, shoulder and central pain, mobility/gait, dysphagia, vision, and communication. Each year in Canada 62,000 people experience a stroke. Among stroke survivors, over 6500 individuals access in-patient stroke rehabilitation and stay a median of 30 days (inter-quartile range 19 to 45 days). The 2015 update of theCanadian Stroke Best Practice Recommendations: Stroke Rehabilitation Practice Guidelinesis a comprehensive summary of current evidence-based recommendations for all members of multidisciplinary teams working in a range of settings, who provide care to patients following stroke. These recommendations have been developed to address both the organization of stroke rehabilitation within a system of care (i.e., Initial Rehabilitation Assessment; Stroke Rehabilitation Units; Stroke Rehabilitation Teams; Delivery; Outpatient and Community-Based Rehabilitation), and specific interventions and management in stroke recovery and direct clinical care (i.e., Upper Extremity Dysfunction; Lower Extremity Dysfunction; Dysphagia and Malnutrition; Visual-Perceptual Deficits; Central Pain; Communication; Life Roles). In addition, stroke happens at any age, and therefore a new section has been added to the 2015 update to highlight components of stroke rehabilitation for children who have experienced a stroke, either prenatally, as a newborn, or during childhood. All recommendations have been assigned a level of evidence which reflects the strength and quality of current research evidence available to support the recommendation. The updated Rehabilitation Clinical Practice Guidelines feature several additions that reflect new research areas and stronger evidence for already existing recommendations. It is anticipated that these guidelines will provide direction and standardization for patients, families/caregiver(s), and clinicians within Canada and internationally.

Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT)

Article

Full-text available

Feb 2016
NEUROLOGY

Objective: Our prespecified dose-response analyses of A Very Early Rehabilitation Trial (AVERT) aim to provide practical guidance for clinicians on the timing, frequency, and amount of mobilization following acute stroke. Methods: Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. We used regression analyses and Classification and Regression Trees (CART) to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group. Results: A total of 2,104 patients were enrolled, of whom 2,083 (99.0%) were followed up at 3 months. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety outcomes with increased daily frequency of out-of-bed sessions (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.09 to 1.18, p < 0.001), keeping time to first mobilization and mobilization amount constant. Increased amount (minutes per day) of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p < 0.001). Session frequency was the most important variable in the CART analysis, after prognostic variables age and baseline stroke severity. Conclusion: These data suggest that shorter, more frequent mobilization early after acute stroke is associated with greater odds of favorable outcome at 3 months when controlling for age and stroke severity. Classification of evidence: This study provides Class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Article

Full-text available

Apr 2015
LANCET

Background: Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. Methods: We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0-2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. Findings: Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59-0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93-1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. Interpretation: First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations. Funding: National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research.

Triage, Treatment, and Transfer: Evidence-Based Clinical Practice Recommendations and Models of Nursing Care for the First 72 Hours of Admission to Hospital for Acute Stroke

Article

Full-text available

Jan 2015

Stroke is a medical emergency and care provided in the first hours is critical in shaping patients’ long-term recovery and prognosis.1 There is robust evidence demonstrating significant reductions in death and disability with early interventions in acute stroke care, including antiplatelet therapy2 stroke unit (SU) care3 and thrombolysis.4 International clinical guidelines for stroke provide key recommendations to guide clinical practice5–8; however, uptake of evidence-based care is variable and often less than optimal.9–14 For example, among patients with ischemic stroke, rates for treatment with intravenous recombinant tissue-type plasminogen activator (r-tPA) are relatively low in the USA (5%)9 and Australia (7%),10 compared with Canada (12%)11 and some European centers (14%).15 Nurses play a pivotal role in rapid identification and triage of patients with acute stroke, initial assessment, and coordinating the timely flow of patients with acute stroke through the health system. Nurses enable delivery of relevant time critical treatments, and rapid transfer to acute SUs for ongoing assessment and provision of further treatment. The purpose of this article is to highlight nursing’s essential contribution to the expedient delivery of acute stroke care by providing evidence-based recommendations for clinical practice processes of care and models of care where nurses have a pivotal role during the first 72 hours from arrival at the emergency department through to SU care. A more detailed comprehensive overview of nursing and interdisciplinary care for patients with acute ischemic stroke extending beyond the first 72 hours has been published previously.16 Where available in existing guidelines, the class and level of evidence for recommendations shown in tables have been provided using the American Heart Association taxonomy.6 As there is a dearth of evidence from high-quality stroke nursing research, not all the recommendations described …

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): A randomised controlled trial

Article

Jul 2015

Background Early mobilisation after stroke is thought to contribute to the eff ects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.Methods We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteriawere randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.FindingsBetween July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.InterpretationFirst mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refi ning present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.

Could upright posture be harmful in the early stages of stroke? – Author's reply

Article

Oct 2015

Julie Bernhardt

World Stroke Organization Global Stroke Services Guidelines and Action Plan

Article

Oct 2014
Int J Stroke

Every two seconds, someone across the globe suffers a symptomatic stroke. ‘Silent’ cerebrovascular disease insidiously contributes to worldwide disability by causing cognitive impairment in the elderly. The risk of cerebrovascular disease is disproportionately higher in low to middle income countries where there may be barriers to stroke care. The last two decades have seen a major transformation in the stroke field with the emergence of evidence-based approaches to stroke prevention, acute stroke management, and stroke recovery. The current challenge lies in implementing these interventions, particularly in regions with high incidences of stroke and limited healthcare resources. The Global Stroke Services Action Plan was conceived as a tool to identifying key elements in stroke care across a continuum of health models. At the minimal level of resource availability, stroke care delivery is based at a local clinic staffed predominantly by non-physicians. In this environment, laboratory tests and diagnostic studies are scarce, and much of the emphasis is placed on bedside clinical skills, teaching, and prevention. The essential services level offers access to a CT scan, physicians, and the potential for acute thrombolytic therapy, however stroke expertise may still be difficult to access. At the advanced stroke services level, multidisciplinary stroke expertise, multimodal imaging, and comprehensive therapies are available. A national plan for stroke care should incorporate local and regional strengths and build upon them. This clinical practice guideline is a synopsis of the core recommendations and quality indicators adapted from ten high quality multinational stroke guidelines. It can be used to establish the current level of stroke services, target goals for expanding stroke resources, and ensuring that all stages of stroke care are being adequately addressed, even at the advanced stroke services level. This document is a start, but there is more to be done, particularly in the realm of primary prevention. Despite differences in resource availability, the message we wish to convey is that stroke awareness, education, prevention, and treatment should always be feasible. Communities and institutions should set goals to continuously expand their stroke service capabilities. This document is intended to augment stroke advocacy efforts throughout the world, providing a strategic plan for optimizing stroke outcomes.

When Should Physical Rehabilitation Commence after Stroke: A Systematic Review

Article

Mar 2014
Int J Stroke

Knowing when to commence physical rehabilitation after stroke is important to ensure optimal benefit for stroke survivors and efficient health care. The aims of this review were to: determine the effects on mortality, function and complications when physical rehabilitation commences 'early' (within seven days of stroke); and describe the effects of early transfer to rehabilitation wards/hospitals when sustained rehabilitation is unavailable in acute stroke units. From 3751 potential articles we included 5 randomized controlled trials and 38 cohort studies. Meta-analysis was performed with 3 randomized controlled trials involving 159 people to investigate the effects of commencing physical rehabilitation within 24 h of stroke compared to 48 h. Commencing physical rehabilitation within 24 h trended towards greater mortality (Mantel-Haenszel odds ratio 2·58; 95% confidence interval 0·98 to 6·79, P = 0·06), with no differences in complications or health outcomes. The cohort studies provided evidence of benefits when physical rehabilitation was commenced on the day of admission (n = 1), within 3 days of stroke (n = 3), or 'sooner rather than later' (3 of 4 studies). The effect of earlier transfer to rehabilitation was reported in 32 cohort studies. In 23/26 (88%) cohort studies that accounted for age and stroke severity, results favored earlier transfer for improving post-stroke function, with no consensus on timeframes. In summary, the benefits of commencing physical rehabilitation within 24 h of stroke remain unclear from the current literature. Commencing physical rehabilitation or transferring to rehabilitation services 'early' may provide better functional outcomes.

Physical Activity Early after Stroke and Its Association to Functional Outcome 3 Months Later

Article

May 2014

Background Early rehabilitation that includes early mobilization and increased amount of motor activity is hypothesized to be one of the most important factors contributing to the beneficial effect of comprehensive stroke unit treatment, whereas too much bed rest is hypothesized to be harmful. The purpose of the present study was to assess the association between early activity/bed rest and functional outcome 3 months later. Methods This was a prospective cohort study including patients with the diagnosis of stroke admitted to Trondheim University Hospital, Norway. Patients were eligible if they were less than 14 days poststroke and did not receive palliative care. Motor activity/bed rest was recorded in the acute phase using a standard method of observation, and the outcome was assessed by the modified Rankin Scale (mRS) score 3 months later. A proportional odds model was used to analyze the association between motor activity/bed rest and outcome. All analyses were adjusted for age, gender, stroke severity, time from stroke to observation, and prestroke function. Results A total of 106 patients (mean age 79.0 years, 56.6% men) were included. The odds ratio for a higher mRS score (poor outcome) was 1.04 (95% confidence interval [CI] 1.02-1.07, P = .001) as time in bed increased and .97 (95% CI .93-1.02, P = .283) as time in motor activity increased. Conclusions This study confirms that time in bed in the early phase is associated with poor functional outcome 3 months later, indicating that too much bed rest should be avoided in the early phase after stroke.

Early exercise training improves ischemic outcome in rats by cerebral hemodynamics

Article

Aug 2013

This study examined whether very early initiated physical rehabilitation (VEIPR), as a recommended therapy for postischemia, could improve motor performance and cerebral blood flow (CBF). Adult male rats with ischemic injury caused by middle cerebral artery occlusion (MCAO) were trained to run on a treadmill for 30min per day at 12m/min. Through such exercise training for 3 days, the ischemic rats exhibited increased motor function and decreased infarct volume, as measured by a behavioral score and 2,3,5-triphenyltetrazolium chloride (TTC) staining method, as well as accelerated CBF, as detected with laser speckle imaging (LSI). Furthermore, to determine whether the observed improved CBF provided the protective factor for motor function recovery, we investigated the apoptosis of ischemic rat brain microvascular endothelial cells (rBMECs), which accepted the mechanical force of CBF directly, under flow intervention. The findings indicated that a modest flow decreased cell apoptosis in the ischemic condition and that this effect is magnitude dependent, as excessive flow increased apoptosis.