Abstract
BackgroundExtended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients.ObjectiveAs early mobilization has been shown to be feasible and safe, we tested the hypothesis that early sitting could be beneficial to stroke patient outcome.MethodsThis prospective multicenter study tested two sitting procedures at the acute phase of ischemic stroke, in a randomized controlled fashion (clinicaltrials.org registration number NCT01573299). Patients were eligible if they were above 18 years of age and showed no sign of massive infarction or any contra-indication for sitting. In the early-sitting group, patients were seated out of bed at the earliest possible time but no later than one calendar day after stroke onset, whereas the progressively-sitting group was first seated out of bed on the third calendar day after stroke onset. Primary outcome measure was the proportion of patients with a modified Rankin score [0–2] at 3 months post stroke. Secondary outcome measures were a.) prevalence of medical complications, b.) length of hospital stay, and c.) tolerance to the procedure.ResultsOne hundred sixty seven patients were included in the study, of which 29 were excluded after randomization. Data from 138 patients, 63 in the early-sitting group and 75 in the progressively-sitting group were analyzed. There was no difference regarding outcome of people with stroke, with a proportion of Rankin [0–2] score at 3 months of 76.2% and 77.3% of patients in the early- and progressive-sitting groups, respectively (p = 0.52). There was also no difference between groups for secondary outcome measures, and the procedure was well tolerated in both arms.ConclusionDue to a slow enrollment, fewer patients than anticipated were available for analysis. As a result, we can only detect beneficial/detrimental effects of +/- 15% of the early sitting procedure on stroke outcome with a realized 37% power. However, enrollment was sufficient to rule out effect sizes greater than 25% with 80% power, indicating that early sitting is unlikely to have an extreme effect in either direction on stroke outcome. Additionally, we were not able to provide a blinded assessment of the primary outcome. Taking these limitations into account, our results may help guide the development of more effective acute stroke rehabilitation strategies, and the design of future acute stroke trials involving out of bed activities and other mobilization regimens.Trial RegistrationClinicalTrials.gov NCT01573299
Highlights
With an estimated 17 million cases worldwide, of which 70% result from an ischemic injury, stroke has a deep socio-economic impact [1]
We were not able to provide a blinded assessment of the primary outcome. Taking these limitations into account, our results may help guide the development of more effective acute stroke rehabilitation strategies, and the design of future acute stroke trials involving out of bed activities and other mobilization regimens
The inability of the cerebral circulation to adapt to hemodynamic changes, and the dysfunction of the cardiac baroreceptor sensitivity may be expected to limit the use of early upright positioning [4]
Summary
With an estimated 17 million cases worldwide, of which 70% result from an ischemic injury, stroke has a deep socio-economic impact [1]. Compensatory mechanisms (known as cerebral auto-regulation) prevent the cerebral blood flow (CBF) from varying with systemic blood pressure. Cerebral auto-regulation mechanisms are impaired and any fluctuation in blood pressure can affect the CBF directly [5]. When a change in the position of the body occurs, such as from lying to sitting, a potential drop in the systemic blood pressure could theoretically translate in a decrease of the CBF. In view of a potential neurological worsening due to a change in the body position, protocols to lead the patient towards an upright position progressively may be indicated during the acute stroke stage. Clinicians have to weigh potentially beneficial out-of-bed activities in the prevention of complications, against the potential aggravation of neurological deficits, with very little guidance available [6,7,8]. No clear recommendations are available for mobilization of ischemic stroke patients
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