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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

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

Published in: Trials | Issue 1/2017

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Abstract

Background

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.

Methods/design

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.

Discussion

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.
Appendix
Available only for authorised users
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Metadata
Title
Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial
Authors
Helen Rodgers
Lisa Shaw
Helen Bosomworth
Lydia Aird
Natasha Alvarado
Sreeman Andole
David L. Cohen
Jesse Dawson
Janet Eyre
Tracy Finch
Gary A. Ford
Jennifer Hislop
Steven Hogg
Denise Howel
Niall Hughes
Hermano Igo Krebs
Christopher Price
Lynn Rochester
Elaine Stamp
Laura Ternent
Duncan Turner
Luke Vale
Elizabeth Warburton
Frederike van Wijck
Scott Wilkes
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2083-4

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