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

Helen Rodgers, Helen Bosomworth, Hermano I. Krebs, Frederike van Wijck, Denise Howel, Nina Wilson, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L. Cohen, Jesse Dawson, Cristina Fernandez-Garcia, Tracy Finch, Gary A. Ford, Richard Francis, Steven Hogg, Niall Hughes, Christopher I. Price, Laura Ternent, Duncan L. TurnerLuke Vale, Scott Wilkes, Lisa Shaw

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Abstract

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 MIT-Manus 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.
Original languageEnglish
Pages (from-to)51-62
JournalThe Lancet
Volume394
Issue number10192
Early online date22 May 2019
DOIs
Publication statusPublished - 6 Jul 2019

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Upper Extremity
Randomized Controlled Trials
Stroke
cefdinir
Health Services Research
Odds Ratio
Therapeutics
Group Psychotherapy
Arm
Robotics
Activities of Daily Living
Random Allocation
Internet
Registries
Patient Care
Outcome Assessment (Health Care)

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Rodgers, H., Bosomworth, H., Krebs, H. I., van Wijck, F., Howel, D., Wilson, N., ... Shaw, L. (2019). Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. The Lancet, 394(10192), 51-62. https://doi.org/10.1016/S0140-6736(19)31055-4
Rodgers, Helen ; Bosomworth, Helen ; Krebs, Hermano I. ; van Wijck, Frederike ; Howel, Denise ; Wilson, Nina ; Aird, Lydia ; Alvarado, Natasha ; Andole, Sreeman ; Cohen, David L. ; Dawson, Jesse ; Fernandez-Garcia, Cristina ; Finch, Tracy ; Ford, Gary A. ; Francis, Richard ; Hogg, Steven ; Hughes, Niall ; Price, Christopher I. ; Ternent, Laura ; Turner, Duncan L. ; Vale, Luke ; Wilkes, Scott ; Shaw, Lisa. / Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. In: The Lancet. 2019 ; Vol. 394, No. 10192. pp. 51-62.
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title = "Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial",
abstract = "BackgroundLoss 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.MethodsRATULS 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.FindingsBetween 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.InterpretationRobot-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.",
author = "Helen Rodgers and Helen Bosomworth and Krebs, {Hermano I.} and {van Wijck}, Frederike and Denise Howel and Nina Wilson and Lydia Aird and Natasha Alvarado and Sreeman Andole and Cohen, {David L.} and Jesse Dawson and Cristina Fernandez-Garcia and Tracy Finch and Ford, {Gary A.} and Richard Francis and Steven Hogg and Niall Hughes and Price, {Christopher I.} and Laura Ternent and Turner, {Duncan L.} and Luke Vale and Scott Wilkes and Lisa Shaw",
note = "OA article Acceptance requested x 2 ET 13/11/19 and also on 19/11/19 as proposed for REF and dates incomplete. ET",
year = "2019",
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doi = "10.1016/S0140-6736(19)31055-4",
language = "English",
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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 2019, 'Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial', The Lancet, vol. 394, no. 10192, pp. 51-62. https://doi.org/10.1016/S0140-6736(19)31055-4

Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. / Rodgers, Helen; Bosomworth, Helen; Krebs, Hermano I.; van Wijck, Frederike; Howel, Denise; Wilson, Nina; Aird, Lydia; Alvarado, Natasha; Andole, Sreeman; Cohen, David L.; Dawson, Jesse; Fernandez-Garcia, Cristina; Finch, Tracy; Ford, Gary A.; Francis, Richard ; Hogg, Steven; Hughes, Niall; Price, Christopher I.; Ternent, Laura; Turner, Duncan L.; Vale, Luke; Wilkes, Scott; Shaw, Lisa.

In: The Lancet, Vol. 394, No. 10192, 06.07.2019, p. 51-62.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial

AU - Rodgers, Helen

AU - Bosomworth, Helen

AU - Krebs, Hermano I.

AU - van Wijck, Frederike

AU - Howel, Denise

AU - Wilson, Nina

AU - Aird, Lydia

AU - Alvarado, Natasha

AU - Andole, Sreeman

AU - Cohen, David L.

AU - Dawson, Jesse

AU - Fernandez-Garcia, Cristina

AU - Finch, Tracy

AU - Ford, Gary A.

AU - Francis, Richard

AU - Hogg, Steven

AU - Hughes, Niall

AU - Price, Christopher I.

AU - Ternent, Laura

AU - Turner, Duncan L.

AU - Vale, Luke

AU - Wilkes, Scott

AU - Shaw, Lisa

N1 - OA article Acceptance requested x 2 ET 13/11/19 and also on 19/11/19 as proposed for REF and dates incomplete. ET

PY - 2019/7/6

Y1 - 2019/7/6

N2 - BackgroundLoss 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.MethodsRATULS 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.FindingsBetween 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.InterpretationRobot-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.

AB - BackgroundLoss 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.MethodsRATULS 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.FindingsBetween 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.InterpretationRobot-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.

U2 - 10.1016/S0140-6736(19)31055-4

DO - 10.1016/S0140-6736(19)31055-4

M3 - Article

VL - 394

SP - 51

EP - 62

IS - 10192

ER -