Abstract
BackgroundThe RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire.MethodsRAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed.ResultsAll participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events.ConclusionsThis first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high.Trial registrationClinicalTrials.gov, NCT02417532. Registered 11 April 2015.
Highlights
The Robot Assisted Physiotherapy Exercises in the Rex (RAPPER) II study investigates the feasibility, safety and acceptability of using the REX selfstabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users
The first designs of an assisted walking device or “exoskeleton” for people with paralysis were patented in the late nineteenth century [3], but it has taken more than a century of effort to produce workable robotic exoskeletons that may have clinical utility
It is registered on the ClinicalTrials.gov website (ClinicalTrials.gov identifier: NCT02417532) and has ethics committee approval from the United Kingdom (UK) National Health Service (NHS) Health Research Authority (NRES Committee East Midlands – Derby: Regional Ethics Committee (REC) Number – 15/EM/0196) in accordance with the Declaration of Helsinki (59th World Medical Association (WMA) General Assembly, Seoul, October 2008) and the principles of Good Clinical Practice (GCP)
Summary
The RAPPER II study investigates the feasibility, safety and acceptability of using the REX selfstabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. One is characterised by robotic exoskeletons that require the user to supplement their balance with crutches or a walking frame (the Four Point Walking Devices). Examples of this include ReWalk (ReWalk Robotics, Yokneam, Israel), Ekso (Ekso Bionics, Richmond CA, USA) and Indego (Parker Hannifin, OH, USA), The other is REX (Rex Bionics PLC, London, UK); a selfstabilising robotic exoskeleton which requires no supplemental upper body support to balance
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