Background: 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 MITManus
robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task
practice and with usual care.
Methods: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.
Findings: 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.
Interpretation 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.