2. Early mobilization post stroke: What is de evidence?

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Curtis Dawson
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1 RECOVERY OF BODY FUNCTIONS AND ACTIVITIES 2. Early mobilization post stroke: What is de evidence? Prof. Gert Kwakkel Chair Neurorehabilitation VU University Medical Center ( g.kwakkel@vumc.nl ) STROKE ONSET SPONTANEOUS NEUROLOGICAL RECOVERY Early Rehabilitation Late Rehabilitation Chronic phase 0-24 h Days Weeks Month 3 Months 6 Months TIME Hours - days: 1. Organized stroke care; 2. Early mobilization; 3. Intensity of practice Days - Weeks: Early Supported Discharge (ESD) from inpatient care Days - Months: Specific rehabilitation interventions Langhorne et al, Stroke Rehabilitation. Lancet May 14;377(9778):

Evidence for organized stroke unit care versus care on general medical wards stratified by the type of stroke unit Hosp. Stroke Units Rehab. wards ~17% Mobile teams Mixed wards.

2 Evidence for organized stroke unit care versus care on general medical wards stratified by the type of stroke unit Hosp. Stroke Units Rehab. wards ~17% Mobile teams Mixed wards. Long term survival - Trondheim LONG TERM BENEFITS OF HOSPITAL STROKA CARE UNITS? Also more likely to be; living at home independent in ADL Indredavik B et al. Stroke 1999;30: Copyright American Heart Association 2

3 Evidence for (multidisciplinary) organized stroke care Treatment by organized inpatient stroke units (21 trials, N=3994) 21% reduction in death or dependency at 1 year post stroke (OR: 0.79, 95%; CI: ; p = ); Odds are independent of age, gender or stroke type Stroke Unit Trialists Collaboration. Organised inpatient (stroke unit) care for stroke. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD Mentioned factors responsible for effective hospital-based stroke unit care. Implementation of treatment protocols to improve screening and treatment of hyperthermia, hyperglycemia and swallowing? (Site-based) education of multidisciplinary team? [absolute risk difference in mrs 2: ~16% at 90 days] * More prescription of aspirin and antibiotics? Early start of mobilization (< 24 hours post stroke)? Higher daily dose of exercise therapy including weekends? * Middleton et al, Lancet 2011; 378:

4 Effects of early mobilization? Hospital based stroke units vs General Medical Ward Trials SU Control Odds Ratio (95% CI) Akershus 103/ / (0.67, 1.33) Edinburgh 93/155 94/ (0.63, 1.56) Goteborg 108/166 54/ (0.58, 1.74) Perth 10/29 14/ (0.22, 1.71) Trondheim* 54/110 81/ (0.21, 0.61) Umea 52/ / (0.44, 1.14) Total: All Trials 420/ / (0.65, 0.96) * < 12 hour mobilization Favours treatment Favours control Stroke Unit Trialist s Collaboration, Cochrane Review, 2013 Independent factors associated with the survival benefit of stroke unit care (n=17 RCTs, N=3327): Better prevention of complications related with immobility (Early Mobilization) (OR: 0.59; CI: ) -chest infections (OR: 0.60; CI: ) -pressure sores (OR: 0.44; CI: ) Increased use of oxygen (OR: 2.39; CI: ) Better screening to prevent aspiration (OR: 2.42; CI: ) Increased use of paracetamol (OR: 2.88; CI: ) Govan et al, Stroke. 2007;38:

5 What is (early) mobilisation? In bed is Not Mobilisation!! Bernhardt et al, Cerebrovasc. Dis. 2007: 24; 24: Hoe actief zijn patiënten eigenlijk op een ziekenhuis stroke unit? Bernhardt et al, Stroke 2004;35:

6 Physical (in)activity (%) (~5.6 days after stroke from 8 AM to 5 PM) In bed Walk Off the Ward Sitting out bed Transfer Bernhardt et al, Stroke 2004;35: People present during activity (%) (~5.6 days after stroke from 8 AM to 5 PM) 5,2 3,6 60,4 13,9 1,6 15,3 Doctor Nurse Therapist Other Alone Family Bernhardt et al, Stroke 2004;35:

7 Current practice with respect to early mobilization: A Dutch counrty wide survey of 91 (out of 96 HSU s) Early start of mobilisation: Time from stroke onset to mobilisation (n, %) CPGPS CPGPS: Clinical practice guidelines for patients with stroke Current practice < 24 h <24 h 65 (71.4) < 48 h 23 (25.3) < 72 h 1 (1.1) > 72 h 0 (0.0) Unclear 2 (2.2) Otterman et al, Stroke Sep;43(9): Current practice with respect to intensity at workdays: A Dutch country wide survey (n=91 HSU s) CPGPS Current practice Time dedicated to exercise therapy on Monday till Friday: Treatment frequency per 5 workdays (mean, sd) Treatment frequency per day (n, %) Minimal time (in minutes) dedicated to exercise therapy per day (mean, sd) (0.5) 2 Once a day 37 (41.4) Once a day, possibly twice 44 (48.4) Twice a day 9 (9.9) (6) Otterman et al, Stroke Sep;43(9):

8) Minimal amount of therapy time (in minutes) per day (mean,sd) 40 15 (6) Otterman et al, Stroke.

8 Current practice in weekends: A Dutch country wide survey (n=91 HSU s) Weekend policy of hospitals: Treatment frequency per weekend (%) CPGPS 2 No therapy on weekend days Current practice 14 (15.4) One day 2 (2.2) Two days 6 (6.6) Only indication 69 (75.8) Minimal amount of therapy time (in minutes) per day (mean,sd) (6) Otterman et al, Stroke Sep;43(9): The Vitaport Activity Monitor Recording of accelerations of legs/trunk in portable computer Classification of body movements in activities such as walking, sitting, standing, lying, biking etc. 8

9 Postures Lying Sitting Standing Trunk Leg Spent time on activities in a weekend on a stroke unit: Activity profile of an hemiplegic patient of 72 years (FAC 3) weekend 99.63% of the time in static positions by: 1) 33.2% lying on the back in supine position; 2) 24,4% side lying position; 3) 42,2% by sitting in a chair 4) 0.28% to standing positions. Only 0.37% was spent by dynamic activities including 0.008% walking time with the help of a physical therapist. 9

al, Stroke 2004:35; 2529-39 French B et al, Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006073. Cooke et al, BMC Medicine 2010, 8:60.

10 RECOVERY OF BODY FUNCTIONS AND ACTIVITIES STROKE ONSET SPONTANEOUS NEUROLOGICAL RECOVERY MORE = BETTER! (Hyper) acute NeuroRehabilitation Early Rehabilitation Late Rehabilitation Chronic phase 0-24 h Days Weeks Month 3 Months 6 Months TIME Kwakkel et al, Stroke 2004:35; French B et al, Cochrane Database Syst Rev Oct 17;(4):CD Cooke et al, BMC Medicine 2010, 8:60. Veerbeek et al, 2012; May;42(5): Langhorne et al, Lancet May 14;377(9778): Effects of intensive task-oriented upper and lower limb training (N=101) Kwakkel et al, Lancet 1999; 354:

1999; 354: 191-196 N=31 N=3064 Veerbeek JM et al,

11 Effects of intensive task-oriented upper and lower limb training (N=101) Kwakkel et al, Lancet 1999; 354: N=31 N=3064 Veerbeek JM et al, Stroke Nov;42(11): ;

12 34 trials Lohse et al, Stroke 2014; 45: Intensity n=467 trials (N = ) Task & (context) specificity Skilled Nursing How to augment intensity? Caregiver- / Family- Mediated Exercises Robotics (?) CCT Veerbeek et al, PLoS One Feb 4;9(2):e Van den Berg et al, Stroke;47:

13 RECOVERY OF BODY FUNCTIONS AND ACTIVITIES STROKE ONSET WHAT DOES THE AVERT TRIAL TELL US? SPONTANEOUS NEUROLOGICAL RECOVERY MORE = NOT ALWAYS BETTER! (Hyper) acute NeuroRehabilitation Hyper Acute / Early subacute / Late Subacute Late Chronic Rehabilitation phase 0-24 h 1 to 7 days 1 to 3 Months 6 Months TIME N=2104 A Very Early Mobilisation Rehabilitation Trial (AVERT), Lancet 2015 Jul 4;386(9988): (Start < 24 hours post stroke) N=2104 A Very Early Mobilisation Rehabilitation Trial (AVERT), Lancet 2015 Jul 4;386(9988): (Start < 24 hours post stroke) AVERT Trial Collaboration group, Bernhardt J, Langhorne P, Lindley RI, Thrift AG, Ellery F, Collier J, Churilov L, Moodie M, Dewey H, Donnan G. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet Jul 4;386(9988): doi: 13

14 Patients achieving each mrs score at 3 months 4% J Physiother Oct;61(4):220. AVERT Trial Collaboration group. Lancet Jul 4 386(9988): Primary measure of outcome = mrs score at 3 months 14

15 56 sites, 5 countries, >2000 PTs involved. (Australia, New Zealand Malaysia, Singapore, UK) Key characteristics: ~age 72 20% >80 years Time post stroke: 18 h. 20% TACIs rtpa 24% IPH 11-14% AVERT Trial Collaboration group. Lancet Jul 4 386(9988): Time to walking unassisted 50 m by 3 months AVERT Trial Collaboration group. Lancet Apr 16. pii: S (15)

16 Although subgroup analyses showed relatively no significant differences between subgroups: absolutely findings disfavor subgroups with severe strokes (NIHSS > 16) and hemorrhagic strokes when mobilized wbetween 12 and 24 hours! AVERT Trial Collaboration group. Lancet Apr 16. pii: S (15) Some facts: Low number of deaths (7 to 8%) in each treatment arm within first 3 months post stroke. N=2104 Low number of complications at stroke units within first days post stroke Relative high number of good outcomes (ie, mrs 0-2; 46% exp. - 50% con.) High contamination with respect to timing during the 8 years of recruitment of stroke patients. Relatively low number of hemorrhagic strokes (N=258) 16

CART FOR FAVORABLE OUTCOME (mrs 0-2) NIHSS 7.5 or > 7.5 AGE 76 or > 76 AGE 86 or > 86 NIHSS 4.5 or > 4.5 MOB. FREQ. 1.25 or > 1.25 AMOUNT 13.5 or > 13.5 MOB. FREQ 10.25 or > 10.

17 CART FOR FAVORABLE OUTCOME (mrs 0-2) NIHSS 7.5 or > 7.5 AGE 76 or > 76 AGE 86 or > 86 NIHSS 4.5 or > 4.5 MOB. FREQ or > 1.25 AMOUNT 13.5 or > 13.5 MOB. FREQ or > Bernhardt et al, Neurology 2016;86: MORE FREQUENT OUT OF BED MOBILIZATION FAVORS INDEPENDENCY (i.e., mrs: 0-2) Efficacy Favorable Outcome p-value Time to first mobilization (per extra hour) Frequency, median daily sessions (per one extra session) Daily amount, median (per extra 5 minutes) 0.99 ( ) ( ) < ( ) < % improvement with each additional treatment session (if the other 2 factors are kept constant) AVERT Trial Collaboration group. Lancet Jul 4 386(9988): Bernhardt et al, Neurology 2016;86:

18 A LOWER DOSE OF OUT OF BED MOBILIZATION FAVORS INDEPENDENCY (i.e., mrs: 0-2) Efficacy Favorable Outcome p-value Time to first mobilization (per extra hour) Frequency, median daily sessions (per one extra session) Daily amount, median (per extra 5 minutes) 0.99 ( ) ( ) < ( ) < % reduced favorable outcome by each 5 min additional therapy (if the other 2 factors are kept constant) AVERT Trial Collaboration group. Lancet Jul 4 386(9988): Bernhardt et al, Neurology 2016;86: What does AVERT tell us in terms of stroke guidelines (1)? The AVERT trial suggests that very early mobilization of stroke patients may benefit patients if it is applied with higher frequencies but in shorter sessions (i.e., lower doses) out of bed mobilization within the first days post stroke. [Invited Comment:] Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favorable outcome at 3 months [commentary 2]. J Physiother Oct;61(4):

19 What does NOT the AVERT trial tell us? (Almost) nothing about the impact of timing of mobilization within the first 24 hours post stroke Nothing about the effectiveness and quality of acute stroke units. Nothing about time out of bed or sitting in the chair (i.e., activity of out of bed mobilization ). Nothing about the why question (i.e., cause of harm) with respect to early mobilization early post stroke. Nothing about the impact of intensity of practice beyond the first days post stroke. [Invited Comment:] Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favorable outcome at 3 months [commentary 2]. J Physiother Oct;61(4):220. What does AVERT tell us in terms of stroke guidelines (2)? The AVERT trial suggests that very early mobilization of stroke patients may benefit patients if it is applied with higher frequencies but in shorter sessions (i.e., lower doses) out of bed mobilization within the first days post stroke. [Not proven!] This restriction may be particularly recommended for the frail elderly with a stroke, those with a more severe neurological deficits (NIHHS>16) at stroke onset (<24 hours) and those with a hemorrhagic stroke. [Invited Comment:] Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favorable outcome at 3 months [commentary 2]. J Physiother Oct;61(4):

How should we proceed after AVERT? 1) Is the impaired regional cerebral blood flow in penumbral and oligemic areas sensitive to orthostatic variation in particular for those with a severe stroke? (e.

penumbral and oligemic brain areas early post stroke? Durduran et al, Opt Express. 2009 March 2; 17(5): 3884 3902 [Invited Comment:] Kwakkel G.

20 How should we proceed after AVERT? 1) Is the impaired regional cerebral blood flow in penumbral and oligemic areas sensitive to orthostatic variation in particular for those with a severe stroke? (e.g., Hunter et al, 2011; Wojner et al, 2005) 2) Do longer durations out of bed mobilization (which often result in tired and drowsy patients slumping in their chairs), result into reduced rcbf in penumbral and oligemic brain areas early post stroke? Durduran et al, Opt Express March 2; 17(5): [Invited Comment:] Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favorable outcome at 3 months [commentary 2]. J Physiother Oct;61(4):220. Collateral grading for each category of the 4-point scale. Left hemisphere was affected in all examples above. A, Grade 0, representing absent collaterals (0% filling of the occluded territory). B, Grade 1, representing poor collaterals (>0% and 50% filling of the occluded territory). C, Grade 2, representing moderate (>50% and <100% filling of the occluded territory). D, Grade 3, representing good collaterals (100% filling of the occluded territory). Berkhemer et al, Stroke. 2016;47:

21 What is the impact of AVERT on the new DUTCH stroke guidelines (NVN guidelines)? AANBEVELINGEN (onder embargo) Patiënten met een herseninfarct of hersenbloeding die opgenomen zijn op een ziekenhuis stroke unit dienen binnen 24 uur op geleide van kunnen gemobiliseerd te worden. Houd de duur van mobilisatie bij vooral patiënten met een ernstig herseninfarct (NIHSS>16) dan wel hersenbloeding kort (niet langer dan ~10 minuten achtereen) en beperk de frequentie van mobilisatie tot hooguit tot enkele 3 keer binnen de eerste 24 uur na het herseninfarct of hersenbloeding. Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favourable outcome at 3 months [commentary 2]. J Physiother ct;61(4):220. What is the impact of AVERT on the new DUTCH stroke guidelines (NVN guidelines)? AANBEVELINGEN (onder embargo) Patiënten met een herseninfarct of hersenbloeding die opgenomen zijn op een ziekenhuis stroke unit dienen binnen 24 uur op geleide van kunnen gemobiliseerd te worden. Houd de duur van mobilisatie bij vooral patiënten met een ernstig herseninfarct (NIHSS>16) dan wel hersenbloeding kort (niet langer dan ~10 minuten achtereen) en beperk de frequentie van mobilisatie tot hooguit tot enkele 3 keer binnen de eerste 24 uur na het herseninfarct of hersenbloeding. Kwakkel G. Very early mobilisation within 24 hours of stroke results in a less favourable outcome at 3 months [commentary 2]. J Physiother ct;61(4):

Enkele CONCLUSIES CBO (onder embargo!) MATIG GRADE Er worden geen (nadelige) effecten gevonden van vroegtijdige mobilisatie op het al dan niet hebben gehad van trombolyse therapie.

22 Enkele CONCLUSIES CBO (onder embargo!) MATIG GRADE Er worden geen (nadelige) effecten gevonden van vroegtijdige mobilisatie op het al dan niet hebben gehad van trombolyse therapie. Hoog (A) GRADE Er is geen bewijs dat vroeg mobiliseren een gunstig effect heeft op duur van opname op een stroke unit. Hoog (A) GRADE Er is geen bewijs dat door patiënten vroeg te mobiliseren het neurologisch herstel, loopvaardigheid en ADL-zelfstandigheid na drie maanden gunstig kan worden beïnvloed. Hoog (A) GRADE Er is sterk bewijs dat patiënten op geleide van kunnen gemobiliseerd dienen te worden. Hoog (A) GRADE Er is geen bewijs dat door vroeg mobiliseren binnen 24 uur secundaire complicaties kunnen worden voorkomen. Matig GRADE Er is indirect bewijs dat vroeg mobiliseren binnen 24 uur na een herseninfarct of hersenbloeding nadelig kan zijn voor patiënten met een hemorrhagie of ernstige neurologische uitval (NIHSS >16) bij opname op een stroke unit. Thank you for your attention! 22

AVERT Trial Debate: Implications for Practice Have we AVERT ed the real message?

AVERT Trial Debate: Implications for Practice Have we AVERT ed the real message? Jackie Bosch, PhD, OT Reg(Ont) School of Rehabilitation Science McMaster University Vince DePaul PT PhD School of Rehabilitation