The Elements of Stroke Rehabilitation

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1 EBRSR [Evidence-Based Review of Stroke Rehabilitation] 6 The Elements of Stroke Rehabilitation Robert Teasell MD, Norine Foley MSc, Norhayati Hussein MBBS, Mark Speechley PhD Last updated November 2013 Abstract The primary goals of stroke rehabilitation are to encourage and foster functional improvement and neurological recovery. Organised stroke care, processes of care, early timing of rehabilitation and high intensity of rehabilitation therapies are important factors which have been identified as promoting better overall outcomes for individuals with stroke. This chapter examines the evidence for those elements which have been proven to be important in the effectiveness of stroke rehabilitation. 6. The Elements of Stroke Rehabilitation pg. 1 of 54

2 Key Points Individuals with stroke who received organised inpatient stroke units care are more likely to survive, return home and regain independence. Many elements contribute to the success of stroke rehabilitation units. It is unclear if patients who have suffered a hemorrhagic stroke have worse outcomes compared with those who have had an ischemic stroke. There is insufficient evidence to support routine implementation of care pathways for acute stroke management or stroke rehabilitation as care pathways do not improve stroke rehabilitation outcomes or reduce costs. However, compliance with stroke rehabilitation guidelines does improve outcomes. Stroke patients who are appropriate candidates should be admitted to a rehabilitation unit or facility as soon as possible. Very early mobilization may help to prevent medical complications post stroke. Greater intensities of physiotherapy and occupational therapy result in improved functional outcome. It is uncertain whether more-intensive language therapy is better than less-intensive therapy. Greater functional improvements made on interdisciplinary stroke rehabilitation units are maintained over the long-term. Dr. Robert Teasell 801 Commissioners Road East, London, Ontario, Canada, N6C 5J1 Phone: Web: 6. The Elements of Stroke Rehabilitation pg. 2 of 54

3 Table of Contents Abstract... 1 Key Points... 2 Table of Contents The Elements of Stroke Rehabilitation Functional Improvements and Neurological Recovery Hemorrhagic vs. Ischemic Stroke Elements of a Stroke Unit Associated with Improved Outcome What Form of Stroke Unit is Best? What Elements of Care are Associated with Improved Outcomes? Impact of Care Pathways and Guidelines Timing of Stroke Rehabilitation Intensity of Therapy Intensity of Physiotherapy and Occupational Therapy Previous Reviews and Meta-Analyses Intensity of Aphasia Therapy Post Stroke Durability of Rehabilitation Gains Previous Reviews Summary References The Elements of Stroke Rehabilitation pg. 3 of 54

4 6. The Elements of Stroke Rehabilitation 6.1 Functional Improvements and Neurological Recovery Some authors have suggested that the majority of functional recovery after stroke is simply related to spontaneous natural recovery from neurological impairment (Lind 1982, Dobkin 1989). The fact that specialized stroke rehabilitation units and greater intensities of rehabilitation (see later discussion) are associated with improved functional outcomes suggests that neurological recovery alone cannot account for the degree of functional improvements seen in stroke rehabilitation. A more basic science approach to the issue of the brain recovery following stroke is found in section 2. In terms of the expected time course of recovery following stroke, Yagura et al. (2003) suggested that functional recovery is thought to reach 80% of maximum by three months, 95%, by six months and 100% by 12 months. Table 6.1: Studies on Functional Improvement and Neurological Recovery Author, Year Methods Country Pedro Score Roth et al USA No Score Kwakkel et al The Netherlands No Score A prospective cohort of 402 patients consecutively admitted for rehabilitation within three months of stroke was studied. Impairment was quantified with the National Institutes of Health Stroke Scale (NIHSS) while the Functional Independence Measure (FIM) was used to measure disability, in particular the motor and cognitive subscales of the FIM. 101 patients with first-ever ischemic strokes were studied during the first 16 weeks post stroke. Progress of time was categorized into 8 bi-weekly time intervals and was used as the independent covariate in a first-order longitudinal regression model. The bi-weekly time change (progress of time) was related to improvement in upper and lower limb motor recovery assessed with Fugl- Meyer (FM) score and Motricity Index (MI), reduction in visuospatial inattention based on the letter cancellation task, and improvement in walking ability, dexterity, and activities of daily living measured with the Functional Ambulation Categories (FAC), Action Research Arm test, and Barthel Index. Outcomes 342 patients experienced no substantial reduction while 60 patients had a significant reduction in their impairment level. Both groups experienced significant reductions in disability during rehabilitation, including those patients who did not experience a substantial reduction in impairment. Time explained a significant change of 8.4 (42%) measurement units on the Barthel Index for the first 10 weeks poststroke, 1.1 (22%) measurement units on FAC, and 19% on the Action Research Arm test for the first 6 and 8 weeks poststroke. Approximately 25% (for FM-arm) to 26% (for MI-arm) of the significant change in measurements units was explained by time alone for the upper limb compared with 33% for FM-leg and 39% for MI-leg of the lower limb. Time accounted for a reduction of 16% in the letter cancellation task. Observed associations did not change after controlling for covariates such as age, gender, hemisphere of stroke, type of stroke, or intervention. In their assessment of the relationship between impairment and disability after a stroke, Roth et al. (1998) concluded that, although stroke-related impairment and disability are significantly correlated with each other, reduced impairment level alone does not fully explain the reduced disability that occurs during rehabilitation. Even patients without substantial impairment reduction demonstrate disability reduction during rehabilitation, suggesting that rehabilitation has an independent role in improving function beyond that explained by neurological recovery alone. Kwakkel et al. (2006) using a modified form of regression analysis estimated that time alone could explain between 16% and 42% of the observed improvement in many parameters of recovery during the first 6 to 10 weeks post stroke. 6. The Elements of Stroke Rehabilitation pg. 4 of 54

5 However, the authors speculated that the effects of time on recovery were likely overestimated given that patients in the study also received therapeutic interventions. Conclusions Regarding Functional Improvement and Neurological Recovery There is limited (Level 2) evidence that the improvement in disability seen in stroke rehabilitation cannot be explained on the basis of natural recovery of the neurological impairment alone. 6.2 Hemorrhagic vs. Ischemic Stroke Approximately 10% of all strokes are the result of intracerebral hemorrhage (ICH) (Kelly et al. 2003, Paolucci et al. 2003). The proportion of patients presenting with hemorrhagic stroke tends to be higher in Eastern European and Asian countries where the prevalence of untreated hypertension may be higher. (Kalra & Langhorne, 2007). Although primary ICH has been associated with more severe neurologic impairment and higher mortality in the acute phase (up to one half of patients with primary ICH die within the first month), it is generally believed that patients with ICH have a better recovery compared to patients with ischemic strokes. (Table 6.2). Table 6.2 Functional Outcomes of Patients with Hemorrhagic vs. Ischemic Stroke Author, Year Country Pedro Score Jørgensen et al Denmark No Score Methods 1,000 unselected patients with acute stroke of a verified type in the Copenhagen Stoke Study were included. Logistic regression was used to examine the influence of stroke type on outcome, adjusting for age, sex, initial stroke severity, comorbidity and recurrent stroke during hospital stay. Neurological deficits and functional disabilities were evaluated weekly from the time of acute admission throughout the rehabilitation period. Outcomes Eighty-eight (9%) of the sample had intracerebral hemorrhage. The relative frequency of intracerebral hemorrhage rose exponentially with increasing stroke severity. In multivariate analyses, stroke type had no influence on mortality, neurological outcome, functional outcome, or the time course of recovery. Initial stroke severity was the all-important prognostic factor. The relative importance of hypertension and blood pressure on admission was not greater for intracerebral hemorrhage than for infarction. Kelly et al USA No Score Paolucci et al Italy No Score Data from 1064 patients (871 with cerebral infarction, 193 with ICH) admitted for inpatient rehabilitation was examined. FIM admission, discharge and change scores were compared between stroke types. A case-control study of 270 inpatients admitted for inpatient rehabilitation. Patients with sequelae of first stroke were matched for stroke severity, basal disability, age (within 1 year), sex, and onset admission interval (within 3 days). The 2 groups' length of stay, Barthel Index (BI), Rivermead Mobility Index (RMI) and Canadian Neurological Scale (CNS) scores were compared, as well as Total admission FIM score were higher in patients with infarction compared with ICH (59 vs. 51, P=.0001). There was no difference in total discharge FIM score between groups (82.3 ischemic vs ICH, p=0.200). Patients with ICH gained more FIM points during rehabilitation (28 vs. 23.3; P=.002). The ICH patients with the most severely disabling strokes had significantly greater recovery than cerebral infarction patients with stroke of similar severity. Compared with ischemic patients, hemorrhagic patients had significantly higher CNS (7.3 vs. 6.7) and RMI scores (6.6 vs. 5.4) at discharge and higher BI (50 vs. 40) and RMI (38 vs. 29) efficiency scores). Hemorrhagic patients showed a probability of a high therapeutic response on the BI that was approximately 2.5 times greater than that of ischemic patients. 6. The Elements of Stroke Rehabilitation pg. 5 of 54

6 Andersen et al Denmark No Score Katrak et al Australia No Score Chiu et al USA No Score efficiency (gain in score/los) of BI and RMI. Stroke patients with hemorrhagic (ICH) and ischemic strokes were compared with regard to stroke severity and mortality using patients in a national registry of all hospitalized stroke patients (n=39,484) in Denmark, which collected data from The patients underwent an evaluation including stroke severity using the Scandinavian Stroke Scale (SSS). Patients were followed-up from admission until death or censoring in Independent predictors of death were identified by means of a survival model based on 25,123 individuals with a complete data set. 718 consecutive stroke admissions (589 CI and 129 ICH) admitted for inpatient rehabilitation over 9.5 years was studied. The following outcomes were compared between groups: FIM gain, FIM efficiency, Motor Assessment Scale (MAS) change, gait velocity, and discharge destination. Data from the Glycine Antagonist in Neuroprotection (GAIN) Americas trial were used to assess the relationship between stroke type (ischemic vs. hemorrhage) and long-term outcome non-obtunded patients with acute stroke were treated within 6 hours of symptom onset irrespective of hemorrhagic (N = 237) versus ischemic (N = 1367) subtype. Multiple logistic regression analysis was performed to evaluate predictors of mortality and neurologic outcome (modified Rankin scale [mrs] score of 0-1 vs. 2-6 at 3 months) adjusting for baseline National Institutes of Health Stroke Scale score, stroke risk factors, clinical and demographic characteristics, and treatment group. 3,993 (10.1%) of the sample had ICH. Stroke severity was almost linearly related to the probability of having ICH (2% in patients with the mildest stroke and 30% in those with the most severe strokes). Compared with ischemic strokes, ICH was associated with an overall higher mortality risk (Hazard Ratio: 1.564; 95% CI, ). The increased risk was, however, time-dependent; initially, risk was 4-fold, after 1 week it was 2.5-fold, and after 3 weeks it was 1.5-fold. After 3 months stroke type did not correlate to mortality. Patients with ICH were more severely disabled on admission (mean FIM 74.3 vs. 88, p<0.001). ICH patients also had longer median LOS (35 vs. 26 days, p<0.001). By discharge there was no difference in the mean FIM scores between groups (106 vs , p=n/s); however ICH patients had gained significantly more FIM points and their FIM efficiency was higher (0.80 vs. 0.61, p<0.001). Stroke type remained a significant explanatory factor for FIM gain, after adjusting for admission FIM, length of stay, age, and days from stroke onset to rehabilitation admission. The majority of patients in both groups went home at discharge. ICH significantly increased the odds of a poor neurological outcome (odds ratio 1.94, 95% CI: ) and was independently associated with a mean 0.25-point increase in the 3-month mrs score (P =.04). ICH had no effect on mortality compared with ischemic stroke (odds ratio 1.01, 95% CI: ) after adjusting for initial stroke severity and other baseline characteristics. Discussion Jørgensen et al. (1995) found that, after controlling for potential confounders that stroke type (ischemic vs. hemorrhagic) did not influence mortality, the time course of neurological recovery, neurological outcome or the time course of recovery from disability. The apparent effect of poorer outcome among patients with hemorrhagic stroke was due to initial greater stroke severity. Andersen et al. (2009) also reported an initial increased risk of mortality associated with ICH, although the effect was time dependent, disappearing after 3 months. Using data from the Glycine Antagonist in Neuroprotection (GAIN) Americans, Chiu et al. (2010) also examined whether the poor long-term prognosis associated with hemorrhagic stroke could be explained by initial stroke severity. They reported that ICH was an independent predictor of poor neurologic outcome, nearly doubling the odds of long-term disability. 6. The Elements of Stroke Rehabilitation pg. 6 of 54

7 However, ICH was not associated with higher mortality compared with ischemic stroke after adjusting for initial stroke severity and other baseline characteristics. Paolucci et al. (2003) matched patients on the basis of initial stroke severity, age, sex and onset to admission time and reported that ICH patients had superior rehabilitation outcomes and demonstrated a higher therapeutic response on ADL. ICH patients had higher Canadian Neurological Scale scores, Rivermead Mobility scores as well as greater efficiencies in scores. Lengths of hospital stays were similar between the groups. The authors attribute the greater gains, relative to patients with ischemic strokes to better neurological recovery associated with resolving brain compression. Kelly et al. (2003) reported similar results. Although patients with ICH admitted to a rehabilitation hospital had significantly lower FIM scores compared to patients with ischemic stroke, there were no differences in discharge FIM scores between the groups. Patients with ICH had higher FIM change scores. The same pattern, whereby patients with ICH had lower admission FIM scores but gained the same number of FIM points was also reported by Katrak et al. (2009). Although initial disability did not significantly predict the amount of recovery during rehabilitation, initial stroke severity was a strong predictor of functional status at discharge. Lipson et al. (2005) also found no significant differences in discharge FIM scores between ICH and ischemic stroke patients; however, there was no difference in the mean FIM scores on admission despite the fact that ICH patients were admitted for rehabilitation significantly later compared with ischemic stroke patients. Conclusions Regarding Hemorrhagic versus Ischemic Stroke There is conflicting (Level 4) evidence that patients suffering from hemorrhagic stroke have worse long-term outcomes compared with patients with ischemic stroke 6.3 Elements of a Stroke Unit Associated with Improved Outcome What Form of Stroke Unit is Best? Specialized stroke rehabilitation units are associated with better outcomes, compared with mixed rehabilitation wards, general medicine, and mobile stroke teams.: The Stroke Unit Trialists Collaboration (SUTC) systematic review (2013) has described the hierarchical service organization in stroke care, moving along a continuum from more organised to less organised care: 1. Stroke ward: Wards where a multidisciplinary team including specialist nursing staff based in a discrete ward cares exclusively for stroke patients. This category included the following subdivisions: a) Acute stroke units These units accept patients acutely but discharge early (usually within seven days). These units are further subcategorised into: i) intensive model of care with continuous monitoring, high nurse staffing levels and the potential for life support ii) semi-intensive with continuous monitoring high nurse staffing but no life support facilities 6. The Elements of Stroke Rehabilitation pg. 7 of 54

8 iii) non-intensive with no high nurse staffing or life support facilities b) Rehabilitation stroke units Patients are accepted after a period of usually of five to seven days or more, and focus on rehabilitation c) Comprehensive (ie combined acute and rehabilitation) These are stroke units that accept patients acutely but also provide rehabilitation for at least several weeks if necessary. Both the rehabilitation unit and comprehensive unit models offer prolonged periods of rehabilitation. 2. Mixed rehabilitation ward: where a multidisciplinary team including specialist nursing staff in a ward provides a generic rehabilitation service but not exclusively caring for stroke patients. 3. Mobile stroke team: where a peripatetic multidisciplinary team (excluding specialist nursing staff ) provides care in a variety of settings. 4. General medical ward: where care is provided in an acute medical or neurology ward without routine multidisciplinary input The SUTC (2013) reported that more-organised care was consistently associated with improved outcomes, with decreased mortality, institutionalised care and dependency. Based on 21 trials, stroke unit care showed reductions in the odds of death recorded at final (median one year) follow-up (OR 0.87, 95% CI 0.69 to 0.94; P = 0.005), the odds of death or institutionalised care (OR 0.78, 95% CI 0.68 to 0.89; P = ) and the odds of death or dependency (OR 0.79, 95% CI 0.68 to 0.90; P = ) compared to care provided on a general medical ward. Outcomes were independent of patient age, sex, initial stroke severity or stroke type, and appeared to be better in stroke units based in a discrete ward. There was no indication that organised stroke unit care resulted in a longer hospital stay. Subgroup analyses in the SUTC (2013) indicate that the observed benefits of organised stroke unit care are not limited to any one models of stroke unit organisation that were examined. Comprehensive units and mixed assessment/ rehabilitation units, tended to be more effective than care in a general medical ward. There were also trends towards better outcomes within the dedicated stroke rehabilitation ward setting as opposed to the mixed rehabilitation ward, and within the acute (semi-intensive) ward as opposed to the comprehensive ward. Foley et al (2007) compared three models of stroke care (acute, rehabilitation and comprehensive units) and found that all models stroke units were associated with significant reductions in mortality, combined death and dependency and length of stay. However not every model was associated with equal benefit. (Table 6.3) Table 6.3: Mortality and dependency rates for different models of stroke Models of stroke care Mortality OR Death/dependency OR (95% CI) (95% CI) Acute stroke care 0.80 ( ) 0.70 ( ) Combined acute and rehabilitation 0.71 ( ) 0.50 ( ) 6. The Elements of Stroke Rehabilitation pg. 8 of 54

9 Post acute rehabilitation 0.60 ( ) 0.63 ( ) Overall 0.71 ( ) 0.62 ( ) Further analyses in the SUTC (2013) indicate that the observed benefits of organised stroke unit care are not limited to any of the subgroup of patients. Apparent benefits were seen in people of both sexes, aged under and over 75 years, with ischemic or hemorrhagic stroke and across a range of stroke severities. Similarly, Langhorne et al (2013) noted that there whilst stroke unit care reduced death or dependency (RR 0.81; 95% CI: ; P=0.0009; I2=60%) there were no difference in benefits for stroke patients with intracerebral hemorrhage (RR, 0.79; 95% CI, ) when compared to patients with ischemic stroke (RR, 0.82; 95% CI, ;P interaction =0.77). 6.4 What Elements of Care are Associated with Improved Outcomes? Why specialized stroke unit care improves patient outcomes remains unclear. It is likely that the processes of care and the structures that support these processes contribute to their success; however, the issue is complex. In the case of stroke rehabilitation, the unit of study is broad and involves the examination of complex care delivery systems. Furthermore, comparisons of studies, which appear to provide similar interventions, can be quite different. Several features associated with organised stroke unit care have been identified to contribute to the better outcomes: Co-ordinated multidisciplinary staff Regularly scheduled meetings Routine involvement of carers Staff specialization Standardized and early assessments Better diagnostic procedures Early mobilization Prevention of complications Better application of best-evidence" Attention to secondary prevention measures Evans et al. (2001) suggested specific components of acute stroke care that might be associated with decreased mortality and dependence, including: thrombolysis, physiological homeostasis, anticoagulation among patients with atrial fibrillation, early aspirin use and early mobilization. Processes of care were evaluated between a dedicated stroke unit, which included both acute and rehabilitative services and less organized stroke team, located on a general medical ward. Within the first seven days of admission, patients on the stroke unit were more closely monitored neurologically. A greater percentage of patients received oxygen therapy, nasogastric feeding and measures to prevent aspiration. Within the first four weeks of stroke, a greater percentage of stroke unit patients received a formal bedside swallowing assessment, a social work and occupational therapy assessment within 7 days, written evidence of rehabilitation goals and discharge/rehabilitation plans (Evans et al see Table 6.4). Although both groups were comprehensively assessed and investigated, greater attention was paid to evaluations of consciousness, swallowing and communication among patients treated on the 6. The Elements of Stroke Rehabilitation pg. 9 of 54

10 stroke unit. Medical complications were more common among patients admitted to the general medical ward and appeared to be the factor most strongly associated with improved outcome among patients receiving care on the stroke unit. However, to what extent this factor and other unidentified factors contributed to the better outcome is unknown. Table 6.4 Differences in the Processes of Care Between a Stroke Unit and a Stroke Team (Evans et al. 2001). Process of Care Odds Ratio (95% CI) Associated with the Benefit of Stroke Unit Care Formal swallowing assessment with 72 hours 3.3 ( ) Occupational therapy assessment with 72 hours 2.4 ( ) Social work assessment within 72 hours 2.8 ( ) Attention to secondary prevention 2.0 ( ) Assessment of caregiver skill needs 11.3 ( ) Written rehabilitation goals 2.5 ( ) Indredavik et al. (1999) also found aggressive medical management including the use of intravenous saline solutions, oxygen therapy, heparin and Paracetamol to reduce fever was more frequent among patients managed on a stroke unit, compared to treatment received by patients on a general medical ward. Early mobilization was the most significant factor associated with discharge home at six weeks, although it remains unclear whether the benefit resulted from a decrease in medical complications such as deep vein thrombosis and pneumonia, or was due to positive psychological benefits. There were no differences in either the total mean hours of both occupational and physical therapy the groups received, which further highlights the intangible elements of a stroke unit that could account for the better outcomes. In a retrospective study, Ang et al. (2003) reported that patients treated within the integrated stroke unit had a shorter LOS and better functional outcome. The authors speculated that the main reasons for the improved outcome was due to seamless nature of care since patients did not have to be physically transferred to a different facility or wait have to wait for a bed to become available, before intensive rehabilitation therapies could begin. However, the report contained insufficient detail of the interventions provided within the two groups to assess the differences in care processes, which may have been responsible for the observed differences. Strasser et al. (2008) investigated the role of education within existing interdisciplinary rehabilitation units. A multiphase, staff training program compared training and information provision delivered over six-month period with information provision only. The group that received additional training discharged patients with a significantly greater gain in mean motor FIM score (+13.6). The authors speculated that the intervention taught the necessary skills and provided a useful conceptual model to positively impact on team dynamics. Commenting on the changes in stroke care at an Auckland Hospital between 1996 (prior to the establishment of a stroke unit) and 2001, following the establishment of a mobile stroke team, Barber et al. (2004) reported that while there were changes in the processes of stroke care since the implementation of the new stroke services, that there had been no corresponding decrease in mortality (14% in 2001 vs. 17% in 1996). However, greater proportions of patients were treated with aspirin within 24 hours of admission, and were discharged on anticoagulation therapy. Only 24% of patients were kept nil by mouth for 24 hours, compared to 46% in The Elements of Stroke Rehabilitation pg. 10 of 54

11 Rudd et al. (2005), using data from the National Stroke Audit (including England, Wales and Northern Ireland) evaluated the organization, processes of care and outcomes for stroke. The authors found that better processes of care, were more frequently associated with stroke unit care and decreased the risk of death considerably. The risk of death for patients who received care on a stroke unit was estimated to be 75% that of the risk for those receiving treatment on a non-stroke unit. While all of the above mentioned studies have focused on identifying the individual contributions of a variety of therapies or interventions, associated with a good outcome, Wade (2001) warns against the risk of committing a type III error (falsely rejecting the experimental hypothesis of the interactive effects of complex interventions are not considered), by pursuing such a course. He suggests that attempting to deconstruct the elements of specialized stroke rehabilitation therapies, in an effort to establish which isolated component(s) are effective may be flawed, by failing to recognise the interdisciplinary and complementary nature of the stroke rehabilitation. Ballinger et al. (1999) concluded that the types and duration of therapies provided by 13 physical and occupational therapists at four rehabilitation facilities treating stroke patients were heterogeneous and varied between institutions and individuals. It can be difficult to realize the same benefits associated with processes of care from clinical trials when they are translated into usual practice. As Kalra & Langhorne (2007) noted, most stroke units evolve in response to local patients needs, priorities and service arrangements, which may not be replicated in other settings. One of the elements of stoke unit care that has been associated with improved outcome is the prevention of complications. Complications are known to be common following acute stroke. Indredavik et al. (2008) followed 489 acute stroke patients who were admitted to a comprehensive stroke unit and subsequently enrolled in an early supported discharge service. Despite the benefit of the best model of care, medical complications were still common. During the first seven days following stroke, 64% of patients experienced at least one complication. The most common complications were pain, elevated temperature, stroke progression and urinary tract infections. Increasing stroke severity, advancing age and female gender were the strongest predictors of complications. Sorbello et al. (2009) also reported a high frequency of medical complications during the acute period following stroke, with or without early mobilization. 82% of patients experienced at least one complication, the most common being falls and urinary tract infections. These findings suggest that some complications experienced following stroke are difficult or impossible to prevent. Furthermore, it suggests that complications may not impact on stroke outcome as much as previously believed. In contrast to this finding, Govan et al. (2007), using a subset of data from the SUTC, found that patients receiving specialized stroke care had a lower incidence of chest infections, other infections and pressure sores. The prevention and treatment of complications was believed to be a contributing factor in improved outcomes. While it is tempting to try to reduce the gains that patients achieve while on stroke rehabilitation units to the sum of their parts, Whyte and Hart (2003) identified some factors which contribute to the difficulties encountered in attempting to unveil the effective elements of stroke rehabilitation: The broad range of treatments provided, as well as the poor definitions of treatments often described in published reports, means that reproducibility and dissemination of proven therapies may be difficult. 6. The Elements of Stroke Rehabilitation pg. 11 of 54

12 The intensities of treatments provided and the composition of therapy can vary across studies, even when evaluating similar therapies. The importance of patient participation, motivation and engagement is difficult to capture and can influence the result, again, when other factors may be constant between studies. Variations between individual therapists can occur as therapists respond to the responses and cues from patients they are treating. This effect can also result in subtle differences between like therapies and affect the study result. The therapist effect which refers to non-specific treatment effects brought about by the therapists personality, verbal communication skill or degree of warmth and empathy. Conclusions Regarding the Components of Stroke Units Which Contributes to Improved Outcomes The term 'stroke unit' is broad and describes hierarchal service organisation in stroke care along a continuum from more organised to less organised care. There is strong (Level 1a) evidence that individuals with stroke are more likely to survive, return home and regain independence if they received organised inpatient stroke unit care. Many elements contribute to the success of stroke rehabilitation unit. Although improved outcomes have been reported among trials evaluating stroke units, no causal mechanism(s) has been identified and verified. There is moderate (Level 1b) evidence that patients treated on a stroke unit have fewer medical complications. 6.5 Impact of Care Pathways and Guidelines Integrated Care Pathways (ICP) has been recently introduced in an attempt to improve the quality and consistency of stroke rehabilitation care. They have been seen as a means to translate the recommendations from national guidelines to a local setting. In some centres, ICPs have been developed to reduce lengths of hospital stay in an effort to reduce costs. ICPs can also be referred to as care mapping (Falconer et al. 1993). The definition of a care pathway may vary from one institution to another, although there are several common elements and include: being patient focused, the management is evidence-based, is multidisciplinary, documents in detail the clinical process and is constructed in a manner that facilitates an audit of outcomes (Edwards et al. 2004). However, the development and successful implementation of an ICP is time consuming and expensive and raises concerns over their associated opportunity costs. Sulch et al. (2000) described the development of an integrated care pathway as an organized, goaldefined and time management plan that has the potential of facilitating timely interdisciplinary coordination, improving discharge planning and reducing length of hospital stay. Other, less formal systems may include checklists of processes of care (Cadilhac et al. 2004). Kwan et al. (2007) suggested that the development of care pathways might be more appropriate for acute stroke management where they have the greatest potential to alter the highly complex processes of care, rather than in the 6. The Elements of Stroke Rehabilitation pg. 12 of 54

13 rehabilitative phase of stroke when well coordinated service is usually provided by an interdisciplinary team. Table 6.5 The Impact of Care Pathways Author, Year Country Pedro Score Hamrin et al Sweden 4 (RCT) Falconer et al USA 5 (RCT) Sulch et al UK 6 (RCT) Duncan et al USA No Score Sulch et al UK 6 (RCT) Sulch et al UK 6 (RCT) Cadilhac et al Australia No Score Methods 280 acute stroke patients were assigned to be managed by a systematized care procedure with written care plans in accordance with the nursing process model or to be managed according to conventional care. 121 patients were randomized to either the Critical Path Method (CPM), which functions like an interdisciplinary team in the planning, monitoring and control of patient s program and progress, or to usual care (multidisciplinary rehabilitation team), which served as the control. 152 patients were randomized to be managed by an Integrated Care Pathway (ICP) based on evidence of best practice, professional standards and existing infrastructure for facilitating inter-disciplinary coordination, improving discharge planning and reducing length of hospital stay or were to be managed by conventional multi-disciplinary care (control). (see Figure) 288 stroke patients in 11 Dept. of Veteran Affairs Medical centres, hospitalized between 1998 and 1999 were followed prospectively for 6 mos. The degree of compliance with the AHCPR guidelines was correlated with FIM scores. Additional analyses from Sulch et al Quality of life was assessed using the EuroQoL Visual Analogue Scale (EQ-VAS) at 6 mos. Additional analyses from Sulch et al. 2000, investigating the frequency of stroke specific assessments associated with either ICP or multidisciplinary care. Prospective, multicenter, single-blinded evaluating the following models of care: stroke units, mobile services, and conventional care. 21 selected processes of care (PoC) were identified and abstracted from medical records. The PoCs reflected aspects of care received within 24 hours of admission, documentation and general management, and included CT scan, swallowing assessment, allied health assessment, documentation of premorbid functioning and Outcomes Functional improvements within each group were equal and no significant differences between the two groups were found on any of the outcome measures. Of the 80 subjects who completed satisfaction questionnaires, general satisfaction scores at discharge were significantly lower in the CPM group compared to the control group. There were no differences between the groups in motor or cognitive functions at discharge and no differences in the average length of stay or hospital charges. There were no differences in mortality rates, frequency of institutionalization or LOS between the two groups. Conventional multidisciplinary care resulted in higher BI scores between 4 and 12 weeks and higher Quality of Life scores at 12 weeks and 6 months, compared to the ICP group patients. Average compliance scores in acute and post acute settings were 68.2% and 69.5%, respectively. Greater levels of adherence to the rehabilitation guidelines were associated with higher FIM scores. Patients receiving conventional multidisciplinary therapy had significantly higher QoL scores at 6 mos compared to patients in Integrated Care Pathway group (median 72 vs. 63, p<0.005). Increased frequency of stroke-related assessments with ICP, including testing for inattention (84% vs. 60%, p=0.015) and nutritional assessments (89% vs. 70%, p=0.024). Early discharge notifications to general practitioners were also higher among patients in the ICP group. Adherence to key PoC was higher in SUs than in other models. For all patients, adherence to PoC was associated with improved mortality at discharge and trends found with independence at home.468 of 1701 eligible patients participated. (28%) Overall PoC adherence rates for individual care models were SU 75%, mobile service 65%, and conventional care 52% (P<0.001). The adjusted odds of participants being alive at discharge if adhering to all or all but 1 PoC was significant (OR 3.63; 95% CI: 1.04 to 12.66; 6. The Elements of Stroke Rehabilitation pg. 13 of 54

14 Middleton et al Australia 8 (RCT) Quality in Acute Stroke Care (QASC) study Panella et al Italy 6 (RCT) discharge needs, measures to avoid aspiration, deep vein thrombosis and use of antiplatelet agents at discharge related to care models and participant outcomes. Data were collected at acute hospitalization (median 9 days) and at medians of 8 and 28 weeks after stroke. 1,696 stroke patients admitted to an acute stroke unit (ASU) within 48 hours of onset of symptoms were randomized to care on an ASU with standardized treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction with multidisciplinary team building workshops or to a control ASUs received only an abridged version of existing guidelines. The primary outcomes were 90- day death or dependency (modified Rankin scale [mrs] >/=2), Barthel index, and SF-36 physical and mental component summary scores. 14 hospitals were randomized to a clinical pathway (CP) group or to a non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The primary outcome was 30-day mortality. 7-day mortality, LOS, readmission and institutionalization rates after discharge, dependency levels, and complication rates were also assessed. P=0.043). Important trends at 28 weeks were found for being at home (aor 3.09; 95% CI: 0.96 to 9.87; P=0.058) and independent (aor 2.61; 95% CI: 0.96 to 7.10; P=0.061), with complete PoC adherence. 19 ASUs were randomly assigned to intervention (n=10) or control (n=9). Intervention ASU patients were significantly less likely to be dead or dependent at 90 days (42% vs. 58%, p= Patients in the intervention ASU also had a better SF-36 mean physical component summary score (p=0.002). There were no significant differences between groups in mean BI scores or SF-36 mental component summary scores and no differences in 30-day mortality between groups. There was no difference in the 30-day mortality between groups (CP: 7.6% vs. UC: 10.5%, p=0.34). Compared with patients in the UC group, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There were no differences between groups on the other outcomes. An updated Cochrane review (Kwan and Sandercock 2009 ) which included 3 randomized and 12 nonrandomized trials, reported no significant difference between care pathway and control groups in terms of death or alter the eventual discharge destination. In fact, patients managed with a care pathway were more likely to be dependent at discharge (P =0.04); less likely to suffer a urinary tract infection [(OR) 0.51, 95% (CI) 0.34 to 0.79], less likely to be readmitted (OR 0.11, 95% CI 0.03 to 0.39); and more likely to have neuroimaging (OR 2.42, 95% CI 1.12 to 5.25). Evidence from randomised trials suggested that patients' satisfaction and quality of life were significantly lower in the care pathway group (P = 0.02 and P < respectively). This finding was confirmed by Hoeing et al. (2002) who found the structure of care (systematic organization, staffing expertise and technological sophistication was not associated with better functional outcomes whereas interestingly, compliance with AHCPR post stroke rehabilitation guidelines improved those same outcomes. The apparent paradox may signify the importance of using evidence or guidelines to assist rehabilitation clinicians in individualizing the rehabilitation of stroke patients as opposed to a one size fits all approach. In contrast, a more recent cluster-randomized controlled trial (Panella et al. 2012) reported that an evidence-based care pathway that was developed with the input from a multidisciplinary team resulted in a reduction in the odds of 7-day mortality, and increased the odds of return to pre-stroke function. Another cluster randomized controlled trial (Middleton et al. 2011) demonstrated that patients who 6. The Elements of Stroke Rehabilitation pg. 14 of 54

15 were allocated to a stroke unit with standardized evidence-based nursing protocols designed to improve the management of dysphagia, hyperglycemia and fever had better outcomes compared to patients who were randomized to a stroke unit without similar protocol. Sulch et al. (2000, 2002) randomized 152 stroke patients to a rehabilitation program of integrated care pathways (ICP), characterized as an organized, goal-defined and time managed plan with the potential to improve discharge planning and reduce length of hospital stay, or to a conventional multidisciplinary team (MDT) program of conventional rehabilitation. Patients receiving MDT care improved significantly faster between weeks 4 and 12 (median change in Barthel Index 6 vs. 2, p<0.01) and had higher Quality of Life scores, assessed by the EuroQol Visual Analogue Scale (EQ-VAS) at 6 months (72 vs. 63, p<0.005). Although intuitively care pathways should improve the quality of stroke care, the evidence does not support this conclusion. It may be that care pathways simply reinforce rather than change practice. It may also suggest that imposing a blueprint of care, rather than individualizing treatment, does not improve outcomes. Therefore, although organized interdisciplinary stroke rehabilitation units have been shown to improve outcomes, care pathways do not appear to be a contributing component to their success. There is evidence that the use of care pathways may actually be associated with poorer patient satisfaction and quality of life. In contrast, there appears to be strong evidence that adherence to clinical guidelines, which involves application of evidence-based practices at an individual patient level, does improve outcomes. Conclusions Regarding the Impact of Care Pathways Based on the results from three RCTs, there is conflicting (Level 4) evidence to suggest that care pathways improve stroke rehabilitation outcomes. There is moderate (Level 1b) evidence that care pathways do not reduce hospital costs or decrease length of hospital stays. There is strong (Level 1a) evidence that compliance with stroke rehabilitation guidelines and adherence to processes of care result in improved outcomes. There is insufficient evidence to support routine implementation of care pathways for acute stroke management or stroke rehabilitation as care pathways do not improve stroke rehabilitation outcomes or reduce costs. However, compliance with stroke rehabilitation guidelines improves outcomes. 6.6 Timing of Stroke Rehabilitation The results of several studies (Feigenson et al. 1977, Hayes and Carrol 1986, Wertz 1990) have suggested stroke rehabilitation should be initiated soon after stroke to achieve optimal results. In their review, Cifu and Stewart (1999) reported that there were four studies of moderate quality that demonstrated a positive correlation between early onset of rehabilitation interventions following stroke and improved functional outcomes (Table 6.6). These authors noted that Overall, the available literature demonstrates that early onset of rehabilitation interventions within 3 to 30 days post stroke is strongly associated with improved functional outcome. Ottenbacher and Jannell (1993) conducted a meta-analysis including 36 studies with 3,717 stroke survivors, and demonstrated a positive correlation between early intervention of rehabilitation and improved functional outcome. 6. The Elements of Stroke Rehabilitation pg. 15 of 54

16 Maulden et al. (2005) reported on the findings of the Post-Stroke Rehabilitation Outcomes Project (PSROP), an observational, prospective study, which enrolled 1,291 patients from six inpatients rehabilitation facilities in the US. Increases in the length of time from stroke onset to admission to rehabilitation were associated with lower discharge FIM scores and increased LOS for patients with both moderate and severe strokes. Days from stroke onset to admission was also a significant predictor of discharge total FIM score, discharge motor FIM score, discharge mobility FIM score and rehabilitation LOS in regression analysis. The strongest relationship between early admission to rehabilitation and improved functional outcome was among the most severely impaired patients (case-mix group ). However, a literature review by Diserens et al. (2006) examining the potential benefits of early mobilization concluded that no randomized controlled trial had been conducted to enable a comparison of the effects of early (defined as within the first three days of stroke) vs. delayed (greater than 3 days). Individual Studies Several non-randomized trials investigating the effects of timing of rehabilitation interventions were identified (see Table 6.6). Table 6.6 Timing of Stroke Rehabilitation Author, Year Country PEDro Score Paolucci et al Italy No Score Yagura et al Japan No Score Musicco et al Italy No Score Salter et al Canada No Score Methods A case controlled study of 135 stroke patients who received: 1) rehabilitation within the first 20 days post-stroke (short onset) 2) rehabilitation 21 to 40 days post-stroke (medium onset) and rehabilitation 41 to 60 days (long onset) post-stroke. All patients received the same physical therapy program patients were divided into 3 groups based on the time from stroke onset to admission to rehabilitation: Grp 1 <90 days; Grp days; Grp 3 >180 days. 1,716 stroke patients, with moderate to severe disability, consecutively admitted to 20 Italian hospital rehabilitation centers in 1997 and 1998 were followed. Three negative patient outcomes were considered: death, early failure (premature, unwanted interruption of rehabilitation program; absence of any improvement at hospital discharge), and late failure in terms of severe disability (Barthel Index score <40) or poor quality of life (Medical Outcomes Study 36- Item Short-Form Health Survey; questionnaire score <80) 6 months after admission. 435 patients admitted to an inpatient stroke rehabilitation program within 150 days of a first unilateral stroke were studied. Patients were grouped according to time from onset of stroke to admission to the rehabilitation unit: 0 Outcomes Higher dropout rate was noted in the short onset group. Barthel Index scores in the short onset group showed significantly greater rate of improvement than the other two groups. Walking status improved in 71% of non-ambulatory patients in Grp 1, 55% in Grp 2 and 44% in Grp 3.ADLs improved in 67% of totally dependent patients in Grp 1 and 50% in Grps 2 and 3. 74% of patients in Grp 1 were discharged home compared to 60% in Grps 2 and 3. The presence of dementia and pressure ulcers on admission was associated with worse outcomes (OR for any failure or death=1.31; 95% confidence interval [CI], ; OR=1.63; 95% CI, , respectively). Patients who initiated the rehabilitative procedures early (within 7d after stroke) had better long-term outcomes than did those who initiated the rehabilitation after more than 1 month (OR=2.12; 95% CI, ) or from 15 to 30 days after the acute cerebrovascular event (OR=2.11; 95% CI, ). FIM scores at admission and discharge as well as FIM change and FIM efficiency were significantly higher for early admission than for delayed admission patients. LOS was significantly longer among delayed admission patients. There were significant differences on admission 6. The Elements of Stroke Rehabilitation pg. 16 of 54

17 Gagnon et al Canada No Score Huang et al Taiwan No Score Bernhardt et al Australia 8 (RCT) Sorbello et al Australia 7 (RCT) Hu et al Taiwan No Score Langhorne et al Scotland 15, 16-30, 31-60, and days. and discharge FIM scores, FIM change and LOS between groups of patients admitted 0 15 and days post stroke as well as between patients admitted from days and days. However, no significant differences in FIM admission, FIM discharge, FIM change scores or LOS were noted between patients admitted from and days or and days post stroke. 418 stroke patients, matched on age, gender and degree of stroke severity were retrospectively analyzed according to the time from stroke onset to admission to a stroke rehabilitation unit. Three cohorts were assembled; onset < 20 days (short), onset days (moderate), and onset > 40 days (long). Admission, discharge FIM, FIM efficiency, FIM change and LOS were assessed. The charts of 76 patients admitted for inpatient rehabilitation following first-ever stroke were reviewed. Associations with, and predictors of, BI gains were examined at 1, 3, 6 and 12 months. 71 patients within 24 hrs of stroke onset were randomly assigned to receive standard care (SC) (n=33) or SC plus very early mobilization (VEM) (n=38). In the VEM group the goal of first was mobilization within 24 hours of stroke symptom onset. VEM continued daily for the first 14 days after stroke or until discharge (whichever was sooner) and was delivered by a nurse/physiotherapist. It was intended to provide twice the therapy compared with the SC group. The primary safety outcome was the number of deaths at 3 months. A good outcome, defined as a modified Rankin Score (mrs) of 0-2 at 3, 6 and 12 months was also assessed. Additional analysis from AVERT trial, examining the number and severity of complications between groups. Complications were classified according to type (complications of immobility, stroke-related, co-morbidity related, psychological and other) and severity. 154 patients admitted to a stroke intensive care unit were studied prospectively to examine the effects of timing of admission and intensity of therapy on outcome using regression analyses. 32 acute stroke patients (stroke onset < 36 hrs) were randomized to 1 of 4 nurse-led treatment protocols: (a) standard stroke unit care, (b) There were no significant differences between the groups (short, moderate long) on any of the variables assessed. LOS was similar (51 vs. 48 vs. 47 days), as was FIM efficiency (0.53 vs vs. 0.53). Time from stroke onset to rehabilitation was negatively associated with BI gains at 1 mos and 1 yr. There was no significant difference in the number of deaths between groups (SC, 3 of 33; VEM, 8 of 38; p=0.20). Almost all deaths occurred in patients with severe stroke. After adjusting for age, baseline NIHSS score and premorbid mrs score, the odds of experiencing a good outcome were significantly higher at 12 months for the VEM group (OR: 8.15, 95% CI , p<0.01). There was also a trend towards good outcome at 3 months, but not at 6 months. Within 3 months of admission there were no differences in the number or severity of complications between groups. Patients in the SC group experienced a total of 91 counts of complications while patients in the VEM group experienced 87. There were no differences in the severity of complications between groups. Stroke severity (assessed using the NIHSS scale), age, rehab intensity, admission BI score and onset to admission were all significant predictors of increases in BI scores, explaining 64% of the variability in model. Starting rehab one day sooner resulted in a 0.65 point increase in BI score. Timing of rehab was not a significant predictor an independent walking at the time of discharge, but was a predictor of BI score at discharge. With respect to the comparison of EM vs. control, the EM patients were significantly less likely to experience a medical complication resulting from immobility, after 6. The Elements of Stroke Rehabilitation pg. 17 of 54

18 7 (RCT) early mobilization (EM) where patients were encouraged to sit, stand or walk within 24 hrs of stroke and to repeat at least 4 x/day, (c) automated physiological monitoring (AM) or (d) combined EM and AM. Cumming et al. Additional analysis from AVERT trial Australia 7 (RCT) Diserens et al Switzerland 7 (RCT) Sundseth et al Norway 7 (RCT) Bai et al China 4 (RCT) 50 acute ischemic stroke patients with NIHSS score >6 were randomized to an early protocol in which patients were mobilized out of bed after 52 hours or to delayed protocol where patients were mobilized after seven days. All patients were treated with physiotherapy immediately after their admission The primary outcome was development of a serious complication during hospitalization. Secondary outcomes included minor complications, which did not increase length of stay significantly, % of patients with Rankin scores of 0-2 at 3 months and changes in cerebral blood flow. 65 patients admitted to a stroke unit within 24 hours after stroke were assigned to either VEM within 24 hours of admittance or mobilization between 24 and 48 hours (control group). Primary outcome was the proportion of poor outcome (modified Rankin scale score, 3-6). Secondary outcomes were death rate, change in neurological impairment (National Institutes of Health Stroke Scale score), and dependency (Barthel Index 0-17). 364 patients with hemorrhagic stroke were randomized to receive a standardized, threestage rehabilitation program or to a control group that was treated with standard hospital ward, internal medical intervention. Patients in the experimental group began therapy within 24 hours of admission. Therapy was provided for 45 min/day x 5 days/week. During the first month. Therapy continued in hospital and the community for 6 months. Outcomes assessed at baseline, 1, 3 and 6 months included the simplified Fugl-Myer Assessment Scale (FMA) and Modified Barthel Index (MBI). correcting for age, baseline NIH score and cointerventions, within the first 5 days of stroke. There was no longer a significant difference between groups at the 3-month assessment point. Patients in the very early and intensive mobilization group returned to walking significantly sooner than did standard stroke unit care controls (P=0.032; median 3.5 vs. 7.0 days). There were no differences in proportions of patients who were independent on the BI (score of 20) or who had achieved a good outcome on the Rivermead Motor Assessment Scale (score of 10-13) at either 3 or 12 months. VEM group assignment was a significant, independent predictor of independence on the BI at 3 months, but not at 6 months. VEM group assignment was a significant, independent predictor of good outcome on RMA at both 3 and 12 months. Eight patients were in the delayed group were transferred to other hospitals and were not included in the analysis. There were 2 (8%) severe complications in the 25 early mobilization patients and 8 (47%) in the 17 delayed mobilization patients (P < 0.006). There were no differences in the total number of complications or in any of the other outcomes. There were no differences in blood flow in the 26 patients (62%) who underwent serial transcranial Doppler ultrasonography. The median time to first mobilization was 13 hrs for patients in the VEM group and 33 hrs for patients in the control group. At 3 months, the odds of a poor outcome, death and dependency were non-significantly higher in the control group after adjusting for age and stroke severity: (OR, 2.70; 95% CI, ; P=0.12; OR, 5.26; 95% CI, ; P=0.08, and OR, 1.25; 95% CI, ; P=0.73, respectively). Patients in both groups improved over the study period, although patients in the experimental group achieved significantly greater gains on both FMA and MBI scores (p<0.05). The greatest improvement was observed in the first month post stroke. 6. The Elements of Stroke Rehabilitation pg. 18 of 54

19 Although there is a strong correlation between early admission to stroke rehabilitation and improved functional outcomes, demonstrated in both individual studies and based on the results of meta-analysis, this relationship may not be one of cause and effect. Patients with severe strokes (and higher levels of impairment) are also more likely to experience medical complications, or be too impaired to participate in rehabilitation that may delay their admission to a stroke rehabilitation unit. In contrast, mild to moderate stroke patients with fewer medical complicating factors are more likely to be admitted sooner than later to a stroke rehab unit. The results from the individual studies are difficult to compare owing to the variations in the cohorts. The studies authored by Paolucci et al. (2000) and Gagnon et al. (2006) were similar with respect to their categorization of time from stroke onset, although the results were conflicting. Patients in the early onset cohort showed a greater rate of recovery in one study (Paolucci et al. 2000), but not in the other (Gagnon et al. 2006). Yagura et al. (2004) examined the differences in ambulation and ADL status between three groups of patients, divided according to the duration of time from onset of symptoms to stroke rehabilitation admission and reported that patients who were admitted within 90 days of their stroke achieved greater gains in ambulation, upper extremity and ADL function, compared to patients who had been admitted either days or >180 days following stroke. However, while patients who were admitted earlier achieved better outcomes, all patients significantly benefited from rehabilitation regardless of their onset to admission time. Shah et al. (1990) found that interval between stroke onset and admission to rehabilitation was a predictor of achievement of rehabilitation potential among 258 patients recovering from first-ever stroke. A shorter onset time was associated with improved functional outcome. Similarly, Salter et al. (2006) found that early admission to rehabilitation was associated with improvements in ADL ability as measured by the FIM instrument, after controlling for the effects of patients age. The AVERT trial includes 3 publications Bernhardt et al (2008), Sorbello et al. (2009) and Cumming et al. (2011). In the first presentation of results, there were no reported differences between the early mobilization and conventional groups in death or the number and severity of complications 3 months. The authors attributed the lack of statistically significant between study groups to a small sample size. In the second publication, (Sorbello et al. 2009), there was no reported difference between groups in the frequency of medical complications between groups. Finally, in a last publication, Cumming et al. (2011) reported that patients randomized to the early group were able to walk 50 m unassisted, sooner were discharged from hospital slightly earlier (median 6 vs. 7 days) and a greater percentage were discharged home (32% vs. 24%). Additional results from AVERT phase II showed that the early mobilization protocol resulted in delivery of more and earlier therapy (van Wijk et al. 2012). Schedule (hours to first mobilization, dose per day, frequency and session duration) and nature (percentage out-of-bed activity) of therapy differed significantly between the VEM and standard care (SC) groups. Mobilization was earlier, happened on average 3 times per day in those receiving VEM, with the higher median proportion of out-of-bed activity in VEM session (85.5%) compared to median 42.5% in the standard care (van Wijk et al. 2012). In addition to VEM being effective in improving mobility and independence, economic evaluation suggests that VEM is potentially cost effective (Tay-Teo et al, 2008). Patients receiving VEM incurred significantly less costs at 3 months compared to standard care; and the difference in mean per patient total cost persisted at the 12-month assessment (Tay-Teo et al 2008). 6. The Elements of Stroke Rehabilitation pg. 19 of 54

20 The benefit of early mobilization was also investigated in an observer-blinded, pilot randomised controlled trial studying the key aspects of early stroke unit care. In the Very Early Rehabilitation or Intensive Telemetry After Stroke [VERITAS], early mobilization and intensive monitoring was incorporated within a 2x2 factorial study design (Langhorne et al. 2010). The early mobilization intervention arm utilized protocol based on the AVERT trial with respect to the timing, nature, and frequency of the intervention. (Langhorne et al 2010). Degree of mobilization activity, defined as the mean time spent upright per working day, was 61 (SD, 54) minutes in the early mobilization group compared with 42 (SD, 57) minutes with standard care. By Day 5, 74% of patients in the early mobilization group were independent in walking, compared to 44% of patients with standard care. There were also a trend to more patients on the early mobilization protocol being independent at 3 months (Langhorne et al. 2010). Although there was no difference in good outcome at 3 months (defined as modified Rankin Scale score of 0-2) between groups, the odds of medical complications were lower among subjects in the early mobilization group (OR 0.1, 95% CI: to 0.9, p=0.04), after adjusting for age and severity of stroke. Pooling of individual patients' data from AVERT and VERITAS showed that time to first mobilization from symptom onset was significantly shorter among VEM patients (median, 21 hours; IQR: hours) compared with standard care patients (median, 31 hours; IQR: hours) [Craig et al 2010]. VEM patients had significantly greater odds of independence at 3 months compared with standard care patients (adjusted OR, 3.11; 95%CI ) [Craig et al. 2010]. Diserens et al. (2012) also investigated whether early mobilization was safe and effective in preventing serious complications. While patients in the early group had a lower occurrence of severe complications the sample size was small and there were loses in the standard care group. Comparisons with other studies of early mobilization are difficult to make since the criteria used to define early were different. In contrast, Sundseth et al. (2012) provided very clear criteria for defining VEM. A large number of dropouts, particularly in the VEM group, resulted in a non significant trend towards a reduction in poor outcome for VEM patients. The impact of timing to rehabilitation on overall functional outcome was not limited to patients transferred from acute care to rehabilitation. Early initiation of rehabilitation predicted better functional outcome on patients with severe strokes in a stroke intensive care unit with a multidisciplinary stroke care team (Hu et al. 2010). After adjusting for stroke severity and age, patients who started earlier rehabilitation had higher Barthel Index scores at discharge. Commencing rehabilitation one day earlier in the stroke ICU resulted in an increase of the Barthel Index score by 0.65 points (Hu et al. 2010). There is increasing evidence that early mobilization, however it is defined, is not associated with negative effects and may be better for patients compared with delayed mobilization. Fears that hypoperfusion may be associated with early mobilizations, leading to worse outcomes appear to be unfounded. Conclusion Regarding the Timing of Stroke Rehabilitation There is limited (Level 2) evidence that early admission to stroke rehabilitation is associated with improved functional outcomes. There is strong (Level 1a) evidence that very early mobilization following stroke helps to reduce medical complications. 6. The Elements of Stroke Rehabilitation pg. 20 of 54

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