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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 and Shaw, Lisa (2019) Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. The Lancet, 394 (10192). pp. 51-62. ISSN 0140-6736

Item Type: Article

Abstract

Summary
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.

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More Information

Depositing User: Michelle Marshall

Identifiers

Item ID: 10821
Identification Number: https://doi.org/10.1016/S0140-6736(19)31055-4
ISSN: 0140-6736
URI: http://sure.sunderland.ac.uk/id/eprint/10821
Official URL: https://www.sciencedirect.com/science/article/pii/...

Users with ORCIDS

ORCID for Scott Wilkes: ORCID iD orcid.org/0000-0003-2949-7711

Catalogue record

Date Deposited: 29 May 2019 13:58
Last Modified: 30 Sep 2020 11:17

Contributors

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

University Divisions

Faculty of Health Sciences and Wellbeing

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