DOI: 10.5061/dryad.jh15q
title: Data from: Early sitting in ischemic stroke patients (SEVEL): a randomized controlled trial

description: Background: Extended immobility has been associated with medical
 complications during hospitalization. However no clear recommendations are
 available for mobilization of ischemic stroke patients. Objective: As
 early mobilization has been shown to be feasible and safe, we tested the
 hypothesis that early sitting could be beneficial to stroke patient
 outcome. Methods: This 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. Results: One 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. Conclusion: Due 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.
description: Subsequently excluded
 patientsList and causes related
 to the exclusion of the 29 patientsTABLE_1_DESCRIPTION_DatabaseDescription of the populationTABLE_2_TOLERANCE databasePhysiology of the patients during the two types of sitting procedure, and side effects description.TABLE_3_OUTCOME_databasePatients outcome according to the sitting procedureTABLE_4_MEDICAL_COMPLICATIONS databaseMedical complication occurrence and description according to group affiliation