Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT

Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes.The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care.This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations.The trial was set in four NHS trial centres.Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited.Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care.The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years.A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced upper limb therapy, n = 259; usual care, n = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year.Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective.Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required.Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge.Current Controlled Trials ISRCTN69371850.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 54. See the NIHR Journals Library website for further project information.Many people who have arm weakness following a stroke feel that insufficient attention is paid by rehabilitation services to recovery of their arm. Unfortunately, it is currently unclear how best to provide rehabilitation to optimise recovery, but robot-assisted training and therapy programmes that focus on practising functional tasks are promising and require further evaluation. The Robot-Assisted Training for the Upper Limb after Stroke (RATULS) trial evaluated three approaches to rehabilitation for people with moderate or severe difficulty using their arm. These approaches were robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme based on repetitive practice of functional tasks and usual care. Robot-assisted training and the enhanced upper limb therapy programme were provided in an outpatient setting for 45 minutes per session, three times per week, for 12 weeks, in addition to usual care. The Massachusetts Institute of Technology-Manus robotic gym system was selected as it was felt to be the best available technology. The participant sits at a table, places their affected arm onto the Massachusetts Institute of Technology-Manus arm support and attempts to move their arm to play a game on the computer screen. Movements are assisted by the Massachusetts Institute of Technology-Manus if the patient cannot perform the movements themselves. The results of the RATULS trial show that robot-assisted training did not result in additional improvement in stroke survivors’ arm use when compared with the enhanced upper limb therapy programme or usual care. Stroke survivors who received enhanced upper limb therapy experienced meaningful improvements in undertaking activities of daily living, when compared with those participants who received either robot-assisted training or usual care. Participants who received enhanced upper limb therapy also experienced benefits in their mobility, compared with usual care participants. Participants and therapists found both therapies acceptable, and described various benefits. A health economic analysis found that neither robot-assisted training nor the enhanced upper limb therapy programme was a cost-effective treatment for the NHS.