BACKGROUND: Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit.
OBJECTIVES: We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.
DESIGN: We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.
SETTING: The trial took place in 56 acute stroke units in five countries.
PARTICIPANTS: We included adult patients with a first or recurrent stroke who met physiological inclusion criteria.
INTERVENTIONS: Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.
MAIN OUTCOME MEASURES: The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis.
DATA SOURCES: Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.
RESULTS: We recruited 2104 (UK, n = 610; Australasia, n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p
* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.