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Early mobilization post stroke is intended to reduce the risk of medical complications including deep vein thrombosis, pressure sores, painful shoulders, and respiratory infections. The potential benefits of early mobilization have been examined in several RCTs, with ambiguous results. One of the potential sources of variability, which may account for conflicting results, is the difference in the definitions of early mobilization. Early mobilization was defined as early as 12 hours following stroke to as long as 52 hours, while patients in the delayed group were mobilized from time periods ranging from 48 hours to 7 days. Small sample sizes (i.e. under- powered samples sizes) may also have contributed to null findings. In the Akerhus Early Mobilization in Stroke Study (AKEMIS), 65 patients were randomized to a very early mobilization (VEM) group or to a control group following ischemic or hemorrhagic stroke (Sundseth et al. 2012). Patients in both groups received standard stroke unit care. Patients in the VEM group were mobilized as soon as possible (within 24 hours post stroke), while patients in the control group were mobilized between 24 and 48 hours. The median time to first mobilization from stroke onset was significantly shorter for patients in the VEM group (13.1 vs. 33.3 hrs, p<0.001); however, there were no significant differences between groups on any of the outcomes of interest, including poor outcome at 3 months (mRS score of 3-6), death or dependency, dependency, or number of complications at 3 months. Diserens et al. (2011) randomized 50 patients with ischemic stroke to either an “early mobilization” group who were mobilized out of bed after 52 hours or to a “delayed mobilization” group where patients were mobilized after 7 days. While there were significantly fewer severe complications among patients in the early mobilization group (8% vs. 47%, p < 0.006), there were no significant differences between groups in the numbers of minor complications, neurological deficits, or blood flow modifications.
Several publications are associated with the A Very Early Rehabilitation Trial for Stroke (AVERT) trial. The safety and feasibility of an early mobilization intervention was first established by Bernhardt et al. (2008) in Phase I, in which 71 patients were randomized to receive either very early and frequent mobilization (upright, out of bed, activity – 2x/day, for 6 days a week until discharge beginning within 24 hours of stroke), or usual multi-disciplinary stroke team care. There was a non-significant increase in the number of patient deaths in the early mobilization group at 3 months (21% vs. 9%, absolute risk difference = 12.0%, 95% CI, 4.3% to 28.2%, p=0.20). 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 very early mobilization (VEM) group (OR= 8.15, 95% CI 1.61-41.2, p<0.01), although not at 3 or 6 months. In AVERT II, examining medical complications associated with VEM, Sorbello et al. (2009) reported there were no differences in the total number of complications between groups. Severe complications or stroke-related complications occurred in 91 patients in the control group compared with 87 in the VEM group. Cumming et al. (2011) reported that patients in the VEM group returned to walking significantly sooner than patients in the standard care group (median of 3.5 vs. 7.0 days, p=0.032). While there were no differences between groups in proportions of patients who were independent in ADL, or who experienced a good outcome at either 3 or 12 months, VEM group assignment was a significant, independent predictor of independence in ADL at 3 months and of good outcome at both 3 and 12 months. Pooling the results from both the AVERT and VERITAS trials, which used similar protocols for early mobilization, Craig et al. (2010) reported that, compared with patients receiving standard care, patients in the VEM group were more likely to be independent in activities of daily living at 3 months (OR= 4.41, 95% CI 1.36-14.32), and were less likely to experience immobility related complications (OR= 0.20, 95%CI 0.10-0.70). The most recent replication of AVERT examined the effectiveness of a protocol of more intensive, early out-of-bed activity. Bernhardt et al. (2015) randomized 2,104 adults (1:1) to receive early mobilization, a task-specific intervention focused on sitting, standing, and walking activity, initiated within 24 hours of stroke onset, or to usual care for 14 days, or until hospital discharge. The median time to first mobilization was significantly earlier in the early mobilization group (18.5 vs. 22.4 hrs, p<0.0001). Patients in the early mobilization group received significantly more out of bed sessions (median of 6.5 vs. 3, p<0.0001) and received more daily therapy (31 vs. 10 min, p<0.0001). However, significantly fewer patients in the early mobilization group had a favourable outcome, the primary outcome, defined as mRS 0-2, at 3 months (46% vs. 50%; adjusted OR=0.73, 95% CI 0.59-0.90, p=0.004). There were no significant differences between groups for any of the secondary outcomes (shift in distribution of mRS, time to achieve assisted- free walking over 50m, proportion of patients able to walk unassisted at 3 months, death or serious adverse events), nor were any interactions identified based on pre-specified sub groups for the primary outcome (age, stroke type, stroke severity, administration of t-PA, or geographical region of recruitment). Further analysis of AVERT data (Bernhardt et al. 2016), controlling for age and stroke severity, suggested that shorter, more frequent mobilization early after acute stroke was associated with improved odds of favorable outcome at 3 months, while increased amount (minutes per day) of mobilization reduced the odds of a good outcome.
Finally, in a recent systematic review (Li et al. 2018), the results from 6 RCTs including AVERT and AKEMIS, were pooled. At 3 months, there was no significant difference between groups in the proportion of patients with an mRS score of 0-2, although early mobilization was associated with higher Barthel Index scores at 3 months (SMD=0.66, 95% CI 0.0-1.31) and a significantly reduced LOS (WMD=-1.97, 95% CI -2.63 to -1.32).
Adequate intensity of therapy is another important element associated with successful inpatient rehabilitation outcomes. An early systematic review of the effects of intensive rehabilitation interventions (Kwakkel et al. 1997) suggested that greater treatment intensity was associated with significantly higher ADL scores (ES=0.28, 95% CI 0.16-0.41), and better neuromuscular outcomes (ES=0.37, 95% CI 0.13-0.62), but not better functional outcome (ES=0.10, 95% CI -0.10 to 0.30). Several studies since then have found a similar positive relationship between therapy intensity and patient outcomes. Wang et al. (2013) reviewed the charts of 360 patients who were discharged from an inpatient rehabilitation facility following a stroke and found that more than 3 hours of daily total combined therapy time from a physiotherapist (PT), occupational therapist (OT) and speech language pathologist (SLP) was associated with improved functional outcomes when compared to patients receiving less than 3 hours of therapy. Controlling for age, sex, comorbidities, and total baseline motor and cognition scores, patients who received a total therapy time of <3.0 hours per day had significantly lower total FIM gains compared with those treated for ≥3.0 hours per day. In another retrospective study, Foley et al (2012) found that in a multivariate model, including daily time spent in physiotherapy, occupational therapy (OT) and speech-language pathology, only total OT time and total FIM at admission were significant predictors of total FIM gain. The prospective study, Post-Stroke Rehabilitation Outcomes Project (Horn et al. 2005), included a cohort of 830 patients with moderately, or severely-disabling stroke. The authors found that more intensive therapy (based on number of minutes of therapy per day) and more intensive therapy in the early stages (first therapy session) were associated with higher discharge FIM scores. These findings applied to patients with both moderate and severe strokes.
In a more recent systematic review of trials comparing additional dose of rehabilitation interventions vs. standard amount of the same rehabilitation interventions, aimed at improving upper or lower activity, or both, Schneider et al. (2016) reported that the immediate effect of additional rehabilitation was significantly improved measures of activity (SMD=0.39, 95% CI 0.07-0.71, p=0.02). Small increases in additional therapy were not associated with significant improvement in measures of activity, while large increases were.