Robotic-assisted training after stroke: RATULS advances science

摘要

The Robot Assisted Training for the Upper Limb after Stroke (RATULS) trial by Helen Rodgers and colleagues1Rodgers H Bosomworth H Krebs HI et al.Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial.Lancet. 2019; (published online May 22.)http://dx.doi.org/10.1016/S0140-6736(19)31055-4Summary Full Text Full Text PDF PubMed Scopus (181) Google Scholar in The Lancet is, to the best of our knowledge, the largest study (n=770) in the field of robot-assisted arm training for people with stroke. Recruiting from four UK sites, this pragmatic, three-arm, randomised controlled trial compared robot-assisted training, enhanced upper limb training (EULT; matched in dose and frequency to robot-assisted training), and lower-dose usual care. The population for this study was 770 individuals aged at least 18 years (mean age 61 years [SD 14]; 468 [61%] men) with first-ever stroke (1 week to 5 years before enrolment) with moderate to severe upper limb impairment. The primary outcome was upper limb functional success at the end of the intervention (3 months), measured on the Action Research Arm Test (ARAT). Success was identified a priori, with four distinct success criteria (with improvement cutpoints ranging from 3 to 6 points on the ARAT) that varied according to baseline severity. Although not used previously, this approach aimed to more sensitively capture meaningful change relative to a patient's starting point, which makes sense but needs further validation. An additional strength of the study is that interventions and intervention fidelity were well described.2Walker MF Hoffmann TC Brady MC et al.Improving the development, monitoring and reporting of stroke rehabilitation research: consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.Int J Stroke. 2017; 12: 472-479Crossref PubMed Scopus (76) Google Scholar Robot-assisted training did not improve upper limb function (assessed by ARAT) versus usual care (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70–1·96]) or versus matched-dose EULT (aOR 0·78 [98·3% CI 0·48–1·27]). Nor did usual care differ from EULT (aOR 1·51 [98·3% CI 0·90–2·51]). Although some secondary outcome analyses favoured higher-dose training (EULT or robot-assisted training) over usual care, the effects were small. Serious adverse events were few (43 serious adverse events were reported for 39 participants in the robot-assisted training group, 42 were reported for 33 participants in the EULT group, and 29 were reported for 20 participants in the usual care group), none were trial related, and reporting bias is likely because of frequent contact between participants and clinical teams. The cost-utility analysis, not surprisingly, found higher costs for the more intensive treatments (robot-assisted training cost £5387 per participant, EULT cost £4451 per participant, and usual care cost £3785 per participant). Neither robot-assisted training nor EULT would be considered cost-effective at most levels of willingness to pay per quality-adjusted life-year (QALY) worldwide. The promise of robotics as a powerful tool in the treatment of stroke and brain injury continues to excite stroke survivors, carers, researchers, developers, and funders. RATULS aimed to produce reliable and robust data to progress the field; harmonising treatment protocols, devices, and outcomes, including both functional (ARAT) and activities of daily living (ADL) outcomes. The investigators achieved these goals. The 2018 Cochrane systematic review3Mehrholz J Pohl M Platz T Kugler J Elsner B Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke.Cochrane Database Syst Rev. 2018; 9 (CD006876.)PubMed Google Scholar of robot-assisted arm training, which included 45 trials with 1619 participants, reported significantly improved ADL scores (standardised mean difference [SMD] 0·31 [95% CI 0·