Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT)
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Abstract
Objective: Our prespecified dose-response analyses of A Very Early Rehabilitation Trial (AVERT) aim to provide practical guidance for clinicians on the timing, frequency, and amount of mobilization following acute stroke.
Methods: Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. We used regression analyses and Classification and Regression Trees (CART) to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group.
Results: A total of 2,104 patients were enrolled, of whom 2,083 (99.0%) were followed up at 3 months. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety outcomes with increased daily frequency of out-of-bed sessions (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.09 to 1.18, p < 0.001), keeping time to first mobilization and mobilization amount constant. Increased amount (minutes per day) of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p < 0.001). Session frequency was the most important variable in the CART analysis, after prognostic variables age and baseline stroke severity.
Conclusion: These data suggest that shorter, more frequent mobilization early after acute stroke is associated with greater odds of favorable outcome at 3 months when controlling for age and stroke severity.
Classification of evidence: This study provides Class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke.
GLOSSARY
- AVERT=
- A Very Early Rehabilitation Trial;
- CART=
- Classification and Regression Tree;
- CI=
- confidence interval;
- IQR=
- interquartile range;
- mRS=
- modified Rankin Scale;
- NIHSS=
- NIH Stroke Scale;
- OR=
- odds ratio;
- ROC=
- receiver operating characteristic;
- rtPA=
- recombinant tissue plasminogen activator;
- SAE=
- serious adverse event;
- TTFM=
- time from stroke onset to first mobilization out of bed;
- VEM=
- very early mobilization
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was funded by NIHR.
Coinvestigators are listed on the Neurology® Web site at Neurology.org.
Supplemental data at Neurology.org
Editorial, page 2120
- Received August 10, 2015.
- Accepted in final form January 12, 2016.
- Copyright © 2016 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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