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

Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L., Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A., Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Krebs, Hermano Igo, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike and Wilkes, Scott (2017) Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial. Trials, 18 (1). pp. 1-12. ISSN 1745-6215

Item Type: Article



Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke.

Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation.

Setting: NHS stroke services.

Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation.

Randomisation groups:

1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks

2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks

3. Usual NHS care in accordance with local clinical practice

Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment.

Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation.

Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months.

Blinding: outcomes are undertaken by blinded assessors.

Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes.

Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial.

Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0–7 must improve by 3 or more points; baseline ARAT 8–13 improve by 4 or more points; baseline ARAT 14–19 improve by 5 or more points; baseline ARAT 20–39 improve by 6 or more points.

The results from this trial will determine whether robot-assisted training improves upper limb function post stroke.
Trial registration

ISRCTN, identifier: ISRCTN69371850. Registered 4 October 2013.

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Depositing User: Michelle Marshall


Item ID: 10820
Identification Number:
ISSN: 1745-6215
Official URL:

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ORCID for Scott Wilkes: ORCID iD

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Date Deposited: 29 May 2019 13:55
Last Modified: 29 May 2019 14:45


Author: Scott Wilkes ORCID iD
Author: Helen Rodgers
Author: Lisa Shaw
Author: Helen Bosomworth
Author: Lydia Aird
Author: Natasha Alvarado
Author: Sreeman Andole
Author: David L. Cohen
Author: Jesse Dawson
Author: Janet Eyre
Author: Tracy Finch
Author: Gary A. Ford
Author: Jennifer Hislop
Author: Steven Hogg
Author: Denise Howel
Author: Niall Hughes
Author: Hermano Igo Krebs
Author: Christopher Price
Author: Lynn Rochester
Author: Elaine Stamp
Author: Laura Ternent
Author: Duncan Turner
Author: Luke Vale
Author: Elizabeth Warburton
Author: Frederike van Wijck

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Faculty of Health Sciences and Wellbeing

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