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

Loss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care. RATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850. Between April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention. Robot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice. National Institute for Health Research Health Technology Assessment Programme.

Rodgers H ，Bosomworth H ，Krebs HI ，van Wijck F ，Howel D ，Wilson N ，Aird L ，Alvarado N ，Andole S ，Cohen DL ，Dawson J ，Fernandez-Garcia C ，Finch T ，Ford GA ，Francis R ，Hogg S ，Hughes N ，Price CI ，Ternent L ，Turner DL ，Vale L ，Wilkes S ，Shaw L ... -  《-》

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.

Rodgers H ，Bosomworth H ，Krebs HI ，van Wijck F ，Howel D ，Wilson N ，Finch T ，Alvarado N ，Ternent L ，Fernandez-Garcia C ，Aird L ，Andole S ，Cohen DL ，Dawson J ，Ford GA ，Francis R ，Hogg S ，Hughes N ，Price CI ，Turner DL ，Vale L ，Wilkes S ，Shaw L ... -  《-》

Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial.

To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care. Economic evaluation within a randomised controlled trial. Four National Health Service (NHS) centres in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust. 770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke. Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care. Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves. At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis. The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered. ISRCTN69371850.

Fernandez-Garcia C ，Ternent L ，Homer TM ，Rodgers H ，Bosomworth H ，Shaw L ，Aird L ，Andole S ，Cohen D ，Dawson J ，Finch T ，Ford G ，Francis R ，Hogg S ，Hughes N ，Krebs HI ，Price C ，Turner D ，Van Wijck F ，Wilkes S ，Wilson N ，Vale L ... -  《BMJ Open》

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

Rodgers H ，Shaw L ，Bosomworth H ，Aird L ，Alvarado N ，Andole S ，Cohen DL ，Dawson J ，Eyre J ，Finch T ，Ford GA ，Hislop J ，Hogg S ，Howel D ，Hughes N ，Krebs HI ，Price C ，Rochester L ，Stamp E ，Ternent L ，Turner D ，Vale L ，Warburton E ，van Wijck F ，Wilkes S ... -  《Trials》

Effects of robot-assisted upper limb training combined with functional electrical stimulation in stroke patients: study protocol for a randomized controlled trial.

About 17-80% stroke survivors experience the deficit of upper limb function, which strongly influences their independence and quality of life. Robot-assisted training and functional electrical stimulation are commonly used interventions in the rehabilitation of hemiplegia upper extremities, while the effect of their combination remains unclear. The aim of this trial is to explore the effect of robot-assisted upper limb training combined with functional electrical stimulation, in terms of neuromuscular rehabilitation, compared with robot-assisted upper limb training alone. Individuals (n = 60) with the first onset of stroke (more than 1 week and less than 1 year after stroke onset) will be considered in the recruitment of this single-blinded, three-arm randomized controlled trial. Participants will be allocated into three groups (robot-assisted training combined with functional electrical stimulation group, robot-assisted training group, and conventional rehabilitation therapies group) with a ratio of 1:1:1. All interventions will be executed for 45 min per session, one session per day, 5 sessions per week for 6 weeks. The neuromuscular function of the upper limb (Fugl-Meyer Assessment of upper extremity), ability of daily life (modified Barthel Index), pain (visual analogue scale), and quality of life (EQ-5D-5L) will be assessed at the baseline, at the end of this trial and after 3 months follow-up. Two-way repeated measures analysis of variance will be used to compare the outcomes if the data are normally distributed. Simple effects tests will be used for the further exploration of interaction effects by time and group. Scheirer-Ray-Hare test will be used if the data are not satisfied with normal distribution. We expect this three-arm randomized controlled trial to explore the effectiveness of robot-assisted training combined with functional electrical stimulation in improving post-stroke upper limb function compared with robot-assisted training alone. Effect of upper limb robot on improving upper limb function after stroke, identifier: ChiCTR2300073279. Registered on 5 July 2023.

Yang X ，Fengyi W ，Yi C ，Lin Q ，Yang L ，Xize L ，Shaxin L ，Yonghong Y ... -  《Trials》