Saturday, July 23, 2016

Efficacy and Safety of virtual reality in Stroke Rehabilitation: a multicenter randomized trial (EVREST Multicenter)


Now if we could get a written stroke protocol out of this. That is what a great stroke association president would be doing. But fuck we have none, you will be forever screwed until we destroy the complete stroke medical establishment.

 



Efficacy and Safety of virtual reality in Stroke Rehabilitation: a multicenter randomized trial (EVREST Multicenter)


Gustavo Saposnik, Leonardo G Cohen, Muhammad Mamdani, Sepideth Pooyania, Michelle Ploughman, Donna Cheung, Jennifer Shaw,
Judith Hall, Peter Nord, Sean Dukelow, Yongchai Nilanont, Felipe De los Rios, Lisandro Olmos, Mindy Levin, Robert Teasell, Ashley Cohen,
Kevin Thorpe, Andreas Laupacis, Mark Bayley, for Stroke Outcomes Research Canada
Summary
Background Non-immersive virtual reality is an emerging strategy to enhance motor performance for stroke rehabilitation. There has been rapid adoption of non-immersive virtual reality as a rehabilitation strategy despite the limited evidence about its safety and effectiveness. Our aim was to compare the safety and efficacy of virtual reality with recreational therapy on motor recovery in patients after an acute ischaemic stroke.
Methods In this randomized, controlled, single-blind, parallel-group trial we enrolled adults (aged 18–85 years) who had a first-ever ischaemic stroke and a motor deficit of the upper extremity score of 3 or more (measured with the Chedoke-McMaster scale) within 3 months of randomization from 14 in-patient stroke rehabilitation units from four countries
(Canada [11], Argentina [1], Peru [1], and Thailand [1]). Participants were randomly allocated (1:1) by a computer-generated assignment at enrollment to receive a programme of structured, task-oriented, upper extremity sessions (ten sessions, 60 min each) of either non-immersive virtual reality using the Nintendo Wii gaming system (VRWii) or simple recreational activities (playing cards, bingo, Jenga, or ball game) as add-on therapies to conventional rehabilitation over a 2 week
period. All investigators assessing outcomes were masked to treatment assignment. The primary outcome was upper extremity motor performance measured by total time to complete the Wolf Motor Function Test (WMFT) at the end of the 2 week intervention period, analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov,
number NTC01406912.
Findings The study was done between May 12, 2012, and Oct 1, 2015. We randomly assigned 141 patients: 71 received VRWii therapy and 70 received recreational activity. 121 (86%) patients (59 in the VRWii group and 62 in the recreational activity group) completed the fi nal assessment and were included in the primary analysis. Each group improved WMFT performance time relative to baseline (decrease in median time from 43·7 s [IQR 26·1–68·0] to 29·7 s [21·4–45·2], 32·0% reduction for VRWii vs 38·0 s [IQR 28·0–64·1] to 27·1 s [21·2–45·5], 28·7% reduction for recreational activity).
Mean time of conventional rehabilitation during the trial was similar between groups (VRWii, 373 min [SD 322] vs recreational activity, 397 min [345] ; p=0·70) as was the total duration of study intervention (VRWii, 528 min [SD 155] vs recreational activity, 541 min [142]; p=0·60). Multivariable analysis adjusted for baseline WMFT score, age, sex, baselineChedoke-McMaster, and stroke severity revealed no signifi cant diff erence between groups in the primary outcome
(adjusted mean estimate of diff erence in WMFT: 4·1 s, 95% CI –14·4 to 22·6). There were three serious adverse events
during the trial, all deemed to be unrelated to the interventions (seizure after discharge and intracerebral haemorrhage
in the recreational activity group and heart attack in the VRWii group). Overall incidences of adverse events and serious
adverse events were similar between treatment groups.

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