Background Loss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomisedcontrolled 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 limbfunctional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gymsystem for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, threetimes/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisationstratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation ofinterventions compared to usual NHS care. A within-trial analysis, with aneconomic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial. Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points. Discussion The results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke. Trial registration ISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.
Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial
2017-07-20
Rodgers , H , Shaw , L , Bosomworth , H , Aird , L , Alvarado , N , Andole , S , Cohen , D L , Dawson , J , Eyre , J , Finch , T , Ford , G A , Hislop , J , Hogg , S , Howel , D , Hughes , N , Krebs , H I , Price , C , Rochester , L , Stamp , E , Ternent , L , Turner , D , Vale , L , Warburton , E , van Wijck , F & Wilkes , S 2017 , ' Robot assisted training for the upper limb after stroke (RATULS): study protocol for a randomised controlled trial ' , Trials , vol. 18 , no. 1 , 340 (2017) . https://doi.org/10.1186/s13063-017-2083-4
Aufsatz (Zeitschrift)
Elektronische Ressource
Englisch
DDC: | 629 |
BASE | 2019
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