early mobilisation: clinical practice, evidence and - 1300 cherry... · early mobilisation:...

Early mobilisation:

clinical practice,

evidence and

guidelines.

Dr Cherry Kilbride

&

Dr Nicola Hancock

http://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwi7koulmbPKAhVDqxoKHT2zDMMQjRwIBw&url=http://www.123rf.com/photo_33455952_stock-vector-trail-of-human-bare-footsteps-turn-right.html&bvm=bv.112064104,d.d2s&psig=AFQjCNFD5e318kiW9q7UlQhXl7cqkRJpLg&ust=1453200863980149

Brunel University London

Why early mobilisation?

• Early descriptions of stroke units frequently refer to early mobilisation as thought to make an important contribution to the benefits of stroke unit care (Indredavik et al 1999; Bernhardt et al 2015).

• Bed rest is detrimental to the body systems and structures i.e. cardiovascular, respiratory, musculoskeletal & this is likely to slow recovery (Langhorne et al 2011; Allen et al 1999)

• Many stroke patients are physically (and mentally) inactive & the negative effects of sedentary behaviour are increasingly being recognised (Department of Health 2011, Billinger et al 2014,

Saunders et al 2013)

• Can help maximise the window of neuroplasticity and repair (Murphy& Corbett 2009)

Joining Forces Exeter June 2017


Nonetheless….

• Disagreements & concerns about role of early

mobilisation particularly in first 24 hours post stroke

onset (Bernhardt et al 2015, Skarin et al 2011) e.g.

• Impairs cerebral blood flow & cerebral perfusion (Skarin

et al 2011)

• Increase risk of bleeding in haemorrhagic strokes

(Olavarria et al 2014)

• As a result of these theoretical concerns some

clinicians have advocated initial bed rest for stroke

patients (Skarin et al 2011)

• In addition early mobilisation is poorly defined and

lacked direct evidence to support its implementation.



So what is early mobilisation?

• Definitions/understanding of ‘early mobilisation’ and

what interventions are used vary

• What does the term ‘early mobilisation’ mean to you?

• What do you do in your practice?

• What role have guidelines played?



Early mobilisation (4th edn clinical guideline for stroke 2012 )

B) People with acute stroke should be

mobilised within 24 hours of stroke onset,

unless medically unstable, by an appropriately

trained healthcare professional with access to

appropriate equipment



Early mobilisation (5th edn National clinical guideline for stroke 2016 )

3.12 Early Mobilisation

B) Patients with difficulty moving early after stroke who are medically stable should be offered frequent, short daily mobilisations (sitting out of bed, standing or walking) by appropriately trained staff with access to appropriate equipment, typically beginning between 24 and 48 hours of stroke onset.

Mobilisation within 24 hours of onset should only be for patients who require little or no assistance to mobilise.

3.12.2 Sources: A Working Party consensus, B AVERT Trial Collaboration group 2015; Bernhardt

et al, 2016



Components of early mobilisation:

AVERT specify early mobilisation as comprises

out of bed activities early after stroke...

• Sitting out of bed

• Standing

• Walking training



Understanding the complexities of AVERT

i.e. intervention & usual care components



AVERT – landmark trial for

rehabilitation therapy... (2006 -2014)

• AVERT trial has demonstrated that rehabilitation trials can be conducted to the same rigour and scale as trials of drug therapies.

• AVERT was a randomised controlled trial carried out in 56 stroke units across five countries, mainly Australia, UK, New Zealand, Malaysia and Singapore

• It included 2,104 adults who had been admitted within 24 hours of the onset of their first or recurrent stroke and who could participate in mobilisation.

AVERT Trial Collaboration group (2015).



AVERT: A “pragmatic real world trial”

Design: International, multicentre, parallel group, randomised controlled trial testing efficacy and safety of a very early (<24 hours), frequent, higher dose out of bed (very early mobilisation) protocol compared to usual care post stroke.

Clinical questions

1. Does VEM improve functional outcome (measured as being between mRS 0-2) at 3 months?

2. Does VEM reduce the number of complications at 3 months post stroke?

3. Does VEM improve quality of life at 12 months?

4. Is VEM cost effective?



Modified Rankin Score (mRS)

0 No symptoms at all

1 No significant disability despite symptoms; able to carry out all usual duties and activities

2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3 Moderate disability; requiring some help, but able to walk without assistance

4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6 Dead



Eligibility

Inclusion criteria

• Confirmed stroke (first or recurrent ischaemic or haemorrhagic)

• Less than 24 hours since symptom onset

• Age over 18 years, no upper limit

• Physiological parameters within set limits:

• Systolic BP 110-220 mmHG

• Oxygen sats > 92%

• HR 40-110

• Temperature <38.2

• Rouseable to voice

• rtPA permitted

Exclusion criteria

• TIA

• Moderate to severe premorbid

disability (i.e. mRS 3,4,5)

• Admitted directly to ITU

• Unstable cardiac conditions,

severe heart failure

• Progressive neurological

conditions

• For palliative care



Key features of Very Early Mobilisation (VEM)

• Patients allocated randomly to VEM or usual care (for that SU)

• To begin within 24 hours of stroke ONSET

• Focus on out of bed activities i.e. bed sitting, standing and

walking activities, delivered by physiotherapy and nursing staff

• VEM carried out at least 3 times/day in ADDITION TO USUAL

CARE

• VEM mobilisations were titrated according to a patient

functional level (Level one fully dependent to level 4 little or no

dependence)

• Interventions lasted 14 days or until the patient was discharged

from the SU, whichever was sooner.



VEM Not VEM

• Out of bed activities

• Sitting over edge of bed

• Sitting out of bed (active)

• Standing

• Walking

• Task specific focus

• Detailed protocol

• 4 levels of intervention

dependent on functional ability

and progressed in line with

patient recovery

• Sitting out of bed

(passive) – resting time

in and out of bed not

measured

• ** avoid long periods of

sitting out i.e. > 50

minutes***



Usual care

• The usual care group received usual post-stroke care for that stroke unit

• The number and type of mobilisations were not prescribed but were recorded.

• Essential to record usual care to examine differences and similarities in rehabilitation between the two randomised groups

• Standardisation of recording & reporting allows readers to evaluate the transferability of findings to their own practice setting

• Denehy et al (2013) – highlights important issues regarding ‘usual care’ control groups in clinical trials



Key findings

• VEM patients mobilised 4.8 hours earlier (95% CI 4.1-5.7, p<0.0001)

• VEM was carried out by nurses or therapists an average of six times per day, and included an average daily amount of 31 minutes of mobilisation by a physiotherapist measured over 14 days or until transfer of care if earlier.

• 46% of the early mobilisation group compared with 50% of the usual care group made a good recovery three months after the stroke (OR 0.73, 95% CI 0.59 to 0.90).

• Good recovery was defined as no or minimal disability (score 0-2 on the mRS).

• There were no significant differences in the number of deaths or serious side effects, or outcomes for subgroups based on age, stroke severity, stroke type, whether rtPA treatment was given, time to first mobilisation or recruitment region.

• Further analysis indicated that a good recovery might be best achieved with short bursts of mobilisation activity repeated regularly.



Key challenge with trial – contamination

• Contamination occurs when usual care patients receive

the intervention, results of a trial become diluted because

intervention and usual care become more alike.

• In the AVERT study patients were likely situated on a

single ward, and so challenging to keep other ward staff

from seeing the VEM intervention taking place with

randomised patients

• Contamination was a problem for this trial.

• UC clinicians started mobilisation earlier each year

altering the context of the trial.



Clinical query...

Does this mean that we should leave all stroke patients in bed for the first 24 hours post onset (unless they need no or little assistance to mobilise or transfer)?

Sitting out of bed as a passive activity was not part of the AVERT early mobilisation intervention. Active sitting however was part of the very early mobilisation protocol. Use your clinical judgement as always to assess and then not leave sitting for too long (in the AVERT study sitting for more than 50 minutes in the 1st 3 days was discouraged).

Would this also include hoisting patients into tilt in space chairs within the first 24 hours as they may then be engaged more in 'out of bed' activities?

This sounds like it may be a very low level patient if a tilt in space is needed – I would wonder how many patients within the 1st 24 -48 hours of having a stroke (not admission) would be able to sit out for long enough to warrant hoisting etc for a short space of time?

Would you interpret little or no assistance to mobilise to mean with assistance of 1 / supervision and independent patients only?

Able to either walk on their own or stand by assistance only.



Summary

• Apply most caution with the oldest and those with haemorrhagic stroke as most at risk of death if given very early mobilisation

• Most people in this study, even as part of usual care, started mobilising in less than 24 hours.

• Care needed in interpreting the results re dose of mobilisation as amount of time was not recorded for nursing input

• Therapists in the usual care group could use their clinical judgement about when it was appropriate to mobilise the patient, those randomised to VEM the aim was to mobilise within 24 hours of onset of stroke

• Remember evidence based practice is the judicious use of:

• Research

• Clinical experience

• Patient preference (Sackett 2002)



References

• Allen C, Glasziou P, del Mar C (1999). Bed rest: a potentially harmful treatment needing more careful evaluation. Lancet, 354:

1229-1233

• AVERT Trial Collaboration group (2015). Efficacy and safety of very early mobilisation within 24 hours of stroke onset (AVERT):

a randomised controlled trial. Lancet, 386, 46-55.

• Bernhardt J, Churilov L, Ellery F, Collier J, et al, (2016). Prespecified dose-response analysis for A Very Early Rehabilitation Trial

(AVERT). Neurology, 86, 2138-45.

• Bernhardt J, English C, Johnson L, Cumming TB (2015). Early mobilization after stroke: early adoption but limited evidence.

Stroke, 46: 1141-1146

• Bernhardt J, Thuy MN, Collier JM, Legg LA (2009) Very early versus delayed mobilisation after stroke. Cochrane database of

Systematic Reviews (1): CD:006187

• Billinger SA, Arena R, Bernhardt J, Eng JJ, et al, (2014). Physical activity and exercise recommendations for stroke survivors: a

statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, 45, 2532-53.

• Cumming T, Thrift A, Collier J et al (2011) Very early mobilisation after stroke fast tracks walking: further results from the phase II

AVERT randomized controlled trial. Stroke, 42: 153-158

• Denehy L, Skinner EH, Edbrooke L, et al (2013) Exercise rehabilitation for patients with critical illness: a randomized controlled

trial with 12 months follow up. Critical Care 2013, 17

• Department of Health, 2011. UK physical activity guidelines. London: DH.

• Indredavik B, Bakke RPT, Slordahl SA, Rosketh R, Haheim LL (1999). Treatment in a combined acute and rehabilitation stroke

unit: which aspects are most important? Stroke, 30: 917-923

• Intercollegiate Stroke Working Party (2016) National clinical guidelines for stroke. 5th ed. Royal College of Physicians, London.

• Langhorne P, Bernhardt J, Kwakkel G (2011). Stroke rehabilitation. Lancet, 377: 1693-1702

• Murphy TH, Corbett D (2009) Plasticity during stroke recovery: from synapse to behaviour. Nature Reviews Neuroscience: 10:

861-872

• Olavarria VV, Arima H, Anderson CS et al (2014). Head position and cerebral blood flow velocity in acute ischemic stroke: a

systematic review and meta-analysis. Cerebrovascular Diseases, 37, 401-408

• Saunders DH, Sanderson M, Brazzelli M, Greig CA, et al, (2013). Physical fitness training for stroke patients. Cochrane

Database of Systematic Reviews, 10, CD003316.

• Skarin M, Bernhardt J, Sjoholm A, Nilsson M, Linden T (2011). Better wear out sheets than shoes: a survey of stroke

professionals’ early mobilisation practices and concerns. International Journal of Stroke, 6: p.10-15


D R N I C O L A . J . H A N C O C K

D R C H E R R Y K I L B R I D E

J O I N I N G F O R C E S S T R O K E C O N F E R E N C E

E X E T E R , J U N E 2 0 1 7

Motor Rehabilitation: a “To Do” list

Motor Rehabilitation after Stroke

In essence, stroke causes a motor control problem. Abilities to direct and regulate processes essential to movement, across multiple systems, are impaired

We have developed intervention approaches part in response to our developing knowledge of motor control and how it is impaired after neurological insult

Our research seeks to further develop and refine effective interventions to address motor problems to the benefit of people with stroke

What we know…

Rehabilitation works. But it can be an arduous process. We have a duty to optimise rehabilitation, not just adopt ‘rescue’ interventions¹

We have established that therapy needs to be: Timely (is there a “Golden Window²”?)

Repetitive

Functionally relevant

Sufficiently challenging

And…delivered in systems where resources often conflict with service users’ ambitions for their rehabilitation

How do we exploit what we know?

There are a variety of ways in which we can clinically exploit these evidence-based principles:

Specifically:

Interventions such as CIMT & Electromechanical Gait training are supported in NCGS 2016³

More broadly:

Find innovative methods to meet national recommendations e.g. 45 minutes of therapy

Translational rehabilitation science: mind the gap

The advances of the past 50 years have been considerable

Observe the progression of the rehabilitation guidelines in the NCGS, and the performance of rehabilitation standards on SSNAP

But the pathway of translation to practice is still slow

We have achieved a lot; but we still have a lot to do. The black box remains grey

Have we reached a plateau?

Understanding impairment to optimise function

Does it matter if we don’t fully understand the underlying impairment, nor the correlates of neural recovery and repair?

YES- we would not expect the development and prescription of an antibiotic where nothing was known about the underlying infection 4

Understanding impairment

Recent investigation of motor learning5

People with stroke and healthy controls trained on upper limb task: skill acquisition. Moderate to severe stroke participants matched baseline of mild stroke group, who matched baseline of healthy controls

But this did not make them equivalent; differences in capacity to improve beyond this level- a plateau was reached

“A trained patient is not equal to an untrained patient with less impairment5”

Funding for impairment based work is essential. Research consortia should include basic scientists, clinical scientist, clinicians and service users

An example of developmental work

Investigated Upright Pedalling (UP) on novel prototype

“U-PED1” N=8 stroke survivors, within 30 days of stroke onset, with substantial

weakness

Single session of instrumented UP

Measures included: reciprocal activation quadriceps/hamstrings, smoothness of movement

Promising findings….onwards

90° 270 ̊

TDC

Smooth pedalling demonstrated, with a variety of muscle activation strategies

Next stage: consortium (PT, rehabilitation medicine, engineers, SU reps, Design Council mentor, communication specialist etc. etc…) funding application for development of new U-PED device, using lessons learned from our developmental work

Summary: The Motor Rehabilitation “To do” list

Use existing data better e.g. SSNAP to optimise services to deliver what we know we already do well: individualised, collaborative, inter-disciplinary rehabilitation

Gather the pace on new developments, including technologies, to exploit known principles of rehabilitation

BUT don’t rush into intervention studies without underlying mechanistic investigations: understand impairment to optimise function…

Acknowledgements & references

Dr Cherry Kilbride

Colleagues at UEA ABIRA

References:

1. Hardwick, R. & Celnik, P. J Neurol Neurosurg Psychiatry 2017 doi:10.1136/jnnp-2017-315767

2. Cramer, S. Annals of neurology 2008 doi:10.1002/ana.21393 3. National Clinical Guidelines for Stroke, 5th Ed, 2016; RCP London 4. Pomeroy, V.M. & Tallis, R. The Lancet 2000; 3: 836-837 5. Hardwick, R.M. et al. Neurorehabilitation and Neural Repair 2017 doi:

10.1177/1545968316675432

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