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  • Study design and sample size calculation: The study design was a prospective multicenter, randomized control trial in parallel groups with equal randomization. Patients were enrolled and randomized after screening for inclusion/exclusion criteria and obtaining informed consent. Randomization between early and progressively sitting was performed via numbered sealed envelopes that the investigator would draw from in consecutive fashion (with blocks of 4 in 1:1 ratio, stratified by center) each time a patient was enrolled in the study. The random sequence was generated by our statistician (C.V.) using the SAS software. Data was reported online using a server dedicated to the study. Sample size was estimated from a previous study in which data from 2 individual trials testing early mobilization within 36h of stroke onset were grouped [11]. Calculation was performed based on a type I error risk of 5% and a power of 80%, in a two-sided approach and with a Fisher exact test. A total of 183 patients per group was calculated as necessary to show a difference of 15% in the prevalence of patients showing a Rankin score [0–2] at three month after stroke onset: 35% in the progressive-sitting group versus 50% in the early-sitting group. Additional risk of low tolerance for early sitting was estimated at 9% (from our own observations) so the sample size has been adjusted to a total of 200 patients per group. Protocol approval, registration and patients consent: The SEVEL (Stroke and Early VErticaL positioning) study was approved by the Ethics Committee at the Nantes University Hospital in France (approved September 06th 2011). The authors confirm that all on going and related trials for this intervention are registered. This study was registered at clinicaltrials.org (registration number NCT01573299), with a delay. Indeed it has been registered as a “usual care” study at the level of the Institutional research board, and a miscommunication between our team and the clinical research department caused the delay, which was not sufficiently problematic to force a study restart. Informed and written consent was obtained from all patients. Patients, inclusion and exclusion criteria: Patients were recruited from 11 centers located in the North West region of France. Ischemic stroke was diagnosed by a neurologist and defined by the sudden onset of a persistent neurological deficit without sign of bleeding on the CT scan, or MRI. Patients were eligible to participate in the study if they were above 18 year old, exhibited neurological deficits at the inclusion time, were kept in bed (30° maximum) until inclusion time, and if they were enrolled in a healthcare plan (French social security). Patients had to be included at the earliest possible time, and no later than one calendar day after stroke onset. Exclusion criteria were based on 1. stroke severity (malignant infarction, NIHSS > 22, alteration of consciousness with a Glasgow Coma Score < 13), 2. fluctuation of the neurological signs before admission (history of worsening linked to an upright positioning), 3. known intra-cranial stenosis > 50%, symptomatic of the current episode, 4. minor neurological deficit (isolated facial palsy, isolated hemianopia, isolated sensory impairment), 5. iterative vomiting or difficulty in breathing, 6. contra-indication for sitting, e.g. deep vein thrombosis (diagnosed or suspicion) or lower limb fracture, 7. Pre-admission Rankin score [3–6] 8. anticipated difficult follow up (e.g. not speaking French, living in another region), 9. pregnant women, and 10. enrollment in another trial or refusal to participate. In this study we aimed to test two different protocols for sitting in acute ischemic stroke patients: early and progressive. In the early sitting arm, patients would be seated out of bed at the earliest time possible, but no later that the calendar day after stroke onset. The progressive sitting arm started the day of stroke onset (day 0) when the patient would be positioned in bed at 30°, 45° the day after (day 1) and 60° at day 2 and sitting out of bed at day 3 (which corresponds to the first sitting in this group). Those angles reflect the position of the upper body relative to the bed (and floor). For both protocols, minimal duration of the first sitting was 15 minutes. The procedure could be continued depending on patient fatigue and tolerance (60 minutes maximum). The physiotherapist or the nurses were in charge of collecting the data (blood pressure, tolerance…) related to it. Sitting posture (legs dangling or feet positioned on a foot rest), was done as usual in keeping with each unit’s protocol. The use of a lifter, when necessary, was allowed. Close monitoring of the blood pressure and heart rate was performed: before the sitting procedure, immediately after and 5 minutes after. While sitting, patients showing any sign of low tolerance, defined by neurological worsening (of current or new neurological deficits), vagal reaction (bradycardia or nausea), a greater than 40 mmHg increase of blood pressure topping 180/100mmHg, or a symptomatic decrease in blood pressure, would be put back in bed. Sitting was repeated on a daily basis according to initial tolerance of the procedure, as approved by the physician in charge. Physiotherapy and deep vein thrombosis prevention by low molecular weight heparin were performed as usual in each unit. Evaluations were made during the intermediate time point at 7 days (or the day of discharge, if before 7 days) and at 3-month after stroke, by a neurologist from the same stroke unit, aware of the study and unblinded to the patient group assignment. The primary outcome measure was the proportion of modified Rankin score [0–2] at three months visit after stroke onset. Patients with major deviation to the protocol or serious adverse event that were enrolled but couldn’t continue the study were assigned a Rankin score in the category [3–6]. Secondary outcomes were assessed during the hospital stay at an intermediate time point at 7 days (or the day of discharge, if before 7 days), and also during the 3-month follow-up. At the intermediate evaluation time point, NIHSS and Rankin scores were evaluated. The Rankin, NIHSS and Barthel scores were provided to the study staff from the NINDS or Internet stroke center websites. Data about the tolerance of the sitting positioning (including prevalence of side effects that forced termination of the procedure) was also collected. A final review of the complications that occurred during hospital stay was also performed at 3 months using a multiple-choice list, and based on both patient interview and medical records. The presence of fatigue (question about the presence or not of an abnormal sensation of being tired, which would impact patient’s activity) was assessed at 3 months only. The duration of sitting out of bed was calculated from the recorded time at which the patient was positioned seated out of bed to the time at which the patient would be put back in bed. The observer would directly write on the case report both first sitting time and sitting duration through specific sections. Length of hospitalization was also recorded for each patient. Analyses were performed on all data available from patients whose primary outcome was assessed. Continuous variables were presented with mean and standard deviation. Categorical data were expressed as number and percentages (calculated on the number of available data from each group). Primary and secondary outcomes were compared between groups with Chi square test, Student test, Wilcoxon test or generalized linear mixed models (taking into account randomization stratified by center and baseline NIHSS measure for continuous variable). Linear mixed models included baseline NIHSS as fixed effect and center as random effect. Statistical tests were two-sided, and significance has been set at 0.05. Analyses were conducted using the SAS ® 9.3 software.
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