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Very early versus delayed mobilisation after stroke (Protocol)

Bernhardt J, Collier JM, Legg L

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2006, Issue 4
http://www.thecochranelibrary.com

Very early versus delayed mobilisation after stroke (Protocol)


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Very early versus delayed mobilisation after stroke (Protocol) i


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention protocol]

Very early versus delayed mobilisation after stroke

Julie Bernhardt1 , Janice M Collier1 , Lynn Legg2


1 VeryEarly Rehabilitation Stroke Research Program, National Stroke Research Institute, Heidelberg Heights, Australia. 2 Academic
Section of Geriatric Medicine, University of Glasgow, Glasgow, UK

Contact address: Julie Bernhardt, Very Early Rehabilitation Stroke Research Program, National Stroke Research Institute, Level 1,
Neurosciences Building, Austin Health, Repatriation Campus, 300 Waterdale Road, Heidelberg Heights, Victoria, 3081, Australia.
j.bernhardt@unimelb.edu.au. (Editorial group: Cochrane Stroke Group.)

Cochrane Database of Systematic Reviews, Issue 4, 2008 (Status in this issue: Edited)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD006187
This version first published online: 18 October 2006 in Issue 4, 2006. Re-published online with edits: 8 October 2008 in Issue 4,
2008. (Dates and statuses?)

This record should be cited as: Bernhardt J, Collier JM, Legg L. Very early versus delayed mobilisation after stroke. Cochrane Database
of Systematic Reviews 2006, Issue 4. Art. No.: CD006187. DOI: 10.1002/14651858.CD006187.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To conduct a systematic review of randomised controlled trials (RCTs) to establish if very early mobilisation (started as soon as possible
and no later than 48 hours after onset of symptoms) compared with conventional care in patients with stroke can increase the proportion
of independent survivors.

Very early versus delayed mobilisation after stroke (Protocol) 1


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
BACKGROUND bed, standing, and walking). Conventional care is defined as usual
mobilisation practice.
Stroke presents a major global public health challenge, with 5.5
Any form of very early mobilisation will be considered irrespec-
million people dying from stroke each year (WHO 2003 ) and
tive of the member of staff assisting, duration of the mobilising
many more living with chronic disability (Wolfe 2000). We know
intervention, or amount of intervention.
that treatment in a stroke unit (compared with treatment in a gen-
eral medical ward) reduces the odds of being dead or disabled at
12 months post stroke (SUTC 2001 ). However, relatively little Types of outcome measures
is known about which components of acute stroke unit care may
be responsible for better outcomes (Langhorne 1998; Langhorne Primary outcome of interest
2002). Early rehabilitation interventions, including very early mo-
bilisation, are characteristic features of stroke unit care and have (1) Death or a poor outcome: the number of patients who died
been recommended in a number of acute stroke clinical guidelines or remained dependent (a Barthel score of less than 15 or equiv-
(Adams 2003 ; NSF 2003 ). It is not known whether very early alent, or admission to institutional care, or both, or a modified
mobilisation improves outcome after stroke. Rankin Score of 3 or more) at the end of scheduled follow up
where follow up was performed at three months or longer after
the stroke. Institutional care is defined as care within a residential
home, nursing home, or hospital at the end of scheduled follow
OBJECTIVES up or at discharge.
To conduct a systematic review of randomised controlled trials
(RCTs) to establish if very early mobilisation (started as soon as Secondary outcomes of interest
possible and no later than 48 hours after onset of symptoms) com-
(1) Death: number of deaths from any cause at the end of the
pared with conventional care in patients with stroke can increase
follow up.
the proportion of independent survivors.
(2) Death or dependence: the number of patients dead or phys-
ically dependent at the end of scheduled follow up where follow
up was performed at three months or longer after the stroke.
METHODS (3) The number of patients requiring institutional care at the end
of scheduled follow up where follow up was performed at three
Criteria for considering studies for this review months or longer after the stroke.
(4) Performance in activities of daily living at the end of scheduled
follow up where follow up was performed at three months or longer
Types of studies after the stroke.
We aim to consider all unconfounded randomised trials, with or (5) Performance in extended activities of daily living (community
without blinding, of very early mobilisation within 48 hours of and domestic activities) at the end of scheduled follow up where
symptom onset compared with conventional care (that is, normal follow up was performed at three months or longer after the stroke.
practice or no routine intervention). We will include only the first (6) Patient subjective health status or quality of life at the end
period of any trial employing a randomised crossover design. of scheduled follow up where follow up was performed at three
months or longer after the stroke.
Types of participants (7) Time to walking unassisted (without help from another person)
We will include patients of any age with a definite clinical diagno- reported alone or as part of a functional mobility scale, at the end
sis of stroke (focal neurological deficit caused by cerebrovascular of scheduled follow up where follow up was performed at three
disease) for whom mobilisation could be started within 48 hours months or longer after the stroke.
of the onset of symptoms. (8) Adverse events: number or severity (or both) of adverse effects
including deep vein thrombosis (DVT), non-fatal pulmonary em-
bolism (PE), incidence and grade of new pressure sores (using stan-
Types of interventions
dardised grading scale), number of incontinent episodes over 24
For the purpose of this review, very early mobilisation is defined hours, severity of incontinence, chest infection, falls or injuries,
as any intervention aimed to reduce the time to first mobilisation and physiological variables (blood pressure, oxygen, temperature)
(first out-of-bed episode) and to improve the frequency or amount, recorded at the end of scheduled follow up.
or both, of out-of-bed physical activity (for example, participation (9) Patient mood at the end of scheduled follow up.
in activities of daily living involving mobilising, transfers, or both,
such as walking to the toilet, transferring on and off the toilet with
Search methods for identification of studies
the assistance of one or more staff or equipment, sitting out of

Very early versus delayed mobilisation after stroke (Protocol) 2


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
See: ’Specialized register’ section inCochrane Stroke Group Assessment of methodological quality
We will search the Cochrane Stroke Group Trials Register. In ad- We will extract information, for each included trial, about the
dition, we will carry out searches of the following electronic bibli- method of randomisation and allocation concealment, blinding
ographic databases: the Cochrane Central Register of Controlled of outcome assessment and whether all the randomised patients
Trials (CENTRAL) (The Cochrane Library, latest issue); MED- were accounted for in the analysis. The authors of the trials will be
LINE (1966 to 2006); EMBASE (1980 to 2006); CINAHL (1983 contacted if the above information is not available in the published
to 2006); PsycLIT (1974 to 2006), the Occupational Therapy Re- reports. Sensitivity analyses will be based on these variables.
search Index and Dissertation Abstracts, AMED (1985 to 2006),
PEDro (to 2006), REHABDATA database (to 2006), ongoing tri-
Data extraction
als and research registers, as well as contact with researchers in the
field. We will also search the three citation index databases: Science Our primary aim will be to obtain standardised data through col-
Citation Index (SCI); Social Sciences Citation Index (SSCI); and laboration with the original trialists. Data taken from published
Arts and Humanities Citation Index (A&HCI) (Appendix 1). sources will be independently extracted by two review authors us-
We will also handsearch all available years of the following journals. ing a standard data recording form. Concealment of randomisa-
tion, blinding in outcome evaluation, and intention-to-treat anal-
• Advances in Occupational Medicine and Rehabilitation (1996 ysis will be evaluated and graded as present or unclear. Differences
to 1999) occurring between the two review authors will be resolved through
• Advances in Clinical Neurosciences and Rehabilitation (2001 discussion.
to 2006)
• Advances in Clinical Rehabilitation (1987 to 1990) Data analysis
• Archives of Occupational Therapy (renamed Occupational
For binary outcome variables, a weighted estimate of the inter-
Therapy and Rehabilitation) (1922 to 2006)
vention effects across trials (odds ratio) will be calculated using
• Canadian Journal of Rehabilitation (1987 to 1999)
a fixed-effect model. For continuous outcome data, we will use
• Chinese Journal of Physical Medicine and Rehabilitation (1980
mean difference. Standardised mean difference will be used where
to 2006)
different outcome measures are used to record the same outcome.
• European Journal of Physical Medicine and Rehabilitation
Ninety-five per cent confidence intervals will be used for inter-
(1991 to 1999)
preting the results. Inconsistency across studies will be quantified
• International Journal of Rehabilitation and Health (1995 to
using I-squared (that is, by describing the percentage of the vari-
2000)
ability in the effect estimates that is due to heterogeneity rather
• Journal of Rehabilitation Administration (1987 to 2006)
than sampling error). A value greater than 50% will be considered
• Rehabilitation (1948 to 49, 1951 to 1977)
substantial heterogeneity. A random-effects model will be used if
• Rehabilitation in Canada (1963 to 1972)
there is substantial heterogeneity.
• Rehabilitation Nursing Research (1992 to 1996)
• Topics in Stroke Rehabilitation (1995 to 2006)
Sensitivity analysis
We will search reference lists of all relevant papers.
Sensitivity analyses will be carried out based upon the method of
randomisation and adequacy of allocation concealment, presence
Data collection and analysis of an intention-to-treat analysis, blinding of final assessment, time
We will select trials for inclusion in the review from all studies to first mobilisation, and amount of mobilisation.
found by the methods outlined in the previous section. One re- Missing data for patients excluded or lost to follow up will be
view author will read the titles of all the references identified and analysed using a worst case scenario for the composite outcome
eliminate any obviously irrelevant studies. The abstracts for the of ’death or a poor outcome’ to ensure significance of the results.
remaining studies will be obtained and, based on the inclusion cri- In the worst case analysis, it will be assumed that those patients
teria (types of studies, types of participants, aims of interventions, who were lost to follow up in the intervention group were dead,
outcome measures), two review authors will independently clas- dependent, had deteriorated in ability to perform activities of daily
sify these as ’relevant’, ’irrelevant’ or ’unsure’. Any trials classified living, or required nursing home care at the end of scheduled
as ’irrelevant’ by the review authors will be excluded. Differences follow up. If the effects of primary and worst-case analyses are
in opinion regarding trial eligibility will be resolved by discussion. in the same direction and size of effect, we can draw a definite
All remaining trials will be included at this stage. conclusion about the effectiveness of early mobilisation.

Very early versus delayed mobilisation after stroke (Protocol) 3


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
REFERENCES

Additional references
Adams 2003
Adams HJ, Adams R, Brott T, del Zoppo G, Furlan A, Goldstein L,
et al.Guidelines for the early management of patients with ischemic
stroke: a scientific statement from the Stroke Council of the American
Stroke Association. Stroke 2003;34:1056–83.
Langhorne 1998
Langhorne P, Dennis M. Stroke units: an evidence based approach.
London: BMJ Books, 1998.
Langhorne 2002
Langhorne P, Pollock A. What are the components of effective stroke
unit care?. Age and Ageing 2002;31:365–71.
NSF 2003
The working group of the National Stroke Foundation. National
Clinical Guidelines for Acute Stroke Management. Melbourne: Na-
tional Stroke Foundation, 2003.
SUTC 2001
Stroke Unit Trialists’ Collaboration. Organised inpatient (stroke
unit) care for stroke. Cochrane Database of Systematic Reviews 2001, Is-
sue 1. [Art. No.: CD000197. DOI: 10.1002/14651858.CD000197]
WHO 2003
World Health Organization. World Health Report. World Health Or-
ganization, 2003.
Wolfe 2000
Wolfe C. The impact of stroke. British Medical Bulletin 2000;56:
275–86.

Indicates the major publication for the study

APPENDICES

Appendix 1. MEDLINE search strategy


The following search strategy will be used for MEDLINE and will be modified to suit other databases.
1. early ambulation/
2. Physical Therapy Modalities or “Physical Therapy (Specialty)”/
3. rehabilitation/ or “activities of daily living”/ or recovery of function/
4. movement/ or locomotion/ or walking/ or motor activity/
5. exercise movement techniques/ or exercise/ or exercise therapy/
6. 2 or 3 or 4 or 5
7. time factors/ or time/
8. 6 and 7
9. ((early or earlie$ or accelerat$ or immediate or fast-track or timing or rapid) adj10 (mobil$ or ambulat$ or rehab$ or physiotherapy
or physical therapy or physical activity or movement or sitting or standing or walking or semi-recumb$ or out of bed)).tw.
10. (stroke unit$ or mobility protocol).tw.
11. 1 or 8 or 9 or 10
12. cerebrovascular disorders/ or exp basal ganglia cerebrovascular disease/ or exp brain ischemia/ or exp carotid artery diseases/ or
cerebrovascular accident/ or exp brain infarction/ or exp hypoxia-ischemia, brain/ or exp intracranial arterial diseases/ or exp “intracranial
embolism and thrombosis”/ or exp intracranial hemorrhages/ or exp vasospasm, intracranial/ or exp vertebral artery dissection/
13. (stroke or poststroke or post-stroke or cva or cerebral vascular or cerebrovascular).tw.
Very early versus delayed mobilisation after stroke (Protocol) 4
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
14. ((cerebral or cerebellar or brainstem or vertebrobasilar) adj5 (infarct$ or ischaemi$ or ischemi$ or thrombo$ or emboli$ or
apoplexy)).tw.
15. ((cerebral or brain or subarachnoid) adj5 (haemorrhage or hemorrhage or haematoma or hematoma or bleed$)).tw.
16. hemiplegia/ or exp paresis/
17. (hemipleg$ or hemipar$ or paresis or paretic).tw.
18. or/12-17
19. 11 and 18
20. limit 19 to human
21. randomized controlled trial.pt.
22. randomized controlled trials/
23. controlled clinical trial.pt.
24. controlled clinical trials/
25. random allocation/
26. double-blind method/
27. single-blind method/
28. clinical trial.pt.
29. clinical trials/
30. (clin$ adj5 trial$).tw.
31. ((singl$ or doubl$ or tripl$ or trebl$) adj5 (blind$ or mask$)).tw.
32. (random$ or quasi-random$ or quasi random$).tw.
33. research design/
34. meta analysis.pt.
35. meta-analysis/
36. control groups/
37. ((control or intervention) adj5 group$).tw.
38. (metaanalysis or meta-analysis or meta analysis or systematic review).tw.
39. program evaluation/
40. or/21-39
41. 20 and 40

WHAT’S NEW
Last assessed as up-to-date: 5 August 2006

Date Event Description

12 August 2008 Amended Converted to new review format.

Very early versus delayed mobilisation after stroke (Protocol) 5


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
HISTORY
Protocol first published: Issue 4, 2006

CONTRIBUTIONS OF AUTHORS
Julie Bernhardt drafted the protocol and will participate in all steps of the review. Janice Collier and Lynn Legg refined the protocol and
will perform the planned bibliographic searches, identify studies, assess methodological quality, check the extracted data, and comment
on all drafts of the manuscript.

DECLARATIONS OF INTEREST
None known

Very early versus delayed mobilisation after stroke (Protocol) 6


Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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