A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Langhorne, P. , Wu, O. , Rodgers, H., Ashburn, A. and Bernhardt, J. (2017) A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial. Health Technology Assessment, 21(54), pp. 1-120. (doi:10.3310/hta21540) (PMID:28967376)

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Abstract

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 < 0.0001] earlier, with an additional three (95% CI 3.0 to 3.5; p < 0.0001) mobilisation sessions per day. Fewer patients in the VEM group (n = 480, 46%) had a favourable outcome than in the UC group (n = 525, 50%) (adjusted odds ratio 0.73, 95% CI 0.59 to 0.90; p = 0.004). Results were consistent between Australasian and UK settings. There were no statistically significant differences in secondary outcomes at 3 months and QoL at 12 months. Dose–response analysis found a consistent pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day). Limitations: UC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction. Conclusions: Patients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable outcome at 3 months cautioning against very early high-dose mobilisation. At 12 months, health-related QoL was similar regardless of group. Shorter, more frequent mobilisation early after stroke may be associated with a more favourable outcome. Future work: These results informed a new trial proposal [A Very Early Rehabilitation Trial – DOSE (AVERT–DOSE)] aiming to determine the optimal frequency and dose of EM.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Langhorne, Professor Peter and Wu, Professor Olivia
Authors: Langhorne, P., Wu, O., Rodgers, H., Ashburn, A., and Bernhardt, J.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
Journal Name:Health Technology Assessment
Publisher:NIHR Health Technology Assessment Programme
ISSN:1366-5278
Copyright Holders:Copyright © 2017 Queen's Printer and Controller of HMSO
First Published:First published in Health Technology Assessment 21(54):1-120
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher.

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