Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Abstract

BackgroundLoss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke.Methods/designStudy design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation.Setting: NHS stroke services.Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation.Randomisation groups:1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks3. Usual NHS care in accordance with local clinical practiceRandomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment.Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation.Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months.Blinding: outcomes are undertaken by blinded assessors.Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes.Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial.Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0–7 must improve by 3 or more points; baseline ARAT 8–13 improve by 4 or more points; baseline ARAT 14–19 improve by 5 or more points; baseline ARAT 20–39 improve by 6 or more points.DiscussionThe results from this trial will determine whether robot-assisted training improves upper limb function post stroke.Trial registrationISRCTN, identifier: ISRCTN69371850. Registered 4 October 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2083-4) contains supplementary material, which is available to authorized users.

Robot-Assisted Therapy in Upper Extremity Hemiparesis: Overview of an Evidence-Based Approach

“…Of course, efficiency must be discussed within a local perspective. For example, following the cost containment shown in the VA ROBOTICS study (46), the UK National Health Service commissioned the RATULS study to assess costs within the British system (29). As we expect the RATULS study with 770 stroke patients to be published in June 2019, one might consider how the technology might affect local costs of deployment and expand robotic therapy beyond the clinic to the community and home.…”

“…The Robot Assisted Training for the Upper Limb after Stroke (RATULS) study (29) might clarify things and put everyone in agreement on the topic. Of notice, RATULS goes beyond the Veterans Administration ROBOTICS with chronic stroke or the French REM_AVC study with subacute stroke.…”

Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial

“…Each centre comprised a stroke service in an NHS hospital with an MIT-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Watertown, MA, USA), plus stroke services in adjacent NHS Trusts and community services. The trial protocol was approved by National Research Ethics Committee Sunderland (reference 13/NE/0274) and has been published 8 …”

The future role of robots in neuro-rehabilitation

“…To answer the questions at hand, there are several ongoing clinical trials. The Robot Assisted Training for the Upper Limb after Stroke (RATULS) study [15] probably involves the most participants, more than 700 patients in three randomized groups. The aim of this huge trial is not only to compare the efficacies of the usual, the enhanced traditional, and the robot-mediated therapies, but also to conduct economic analysis.…”