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

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 TernentDuncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

Background

Loss of arm function is a common and distressing consequenceof stroke. We describe the protocol for a pragmatic, multicentre randomisedcontrolled trial to determine whether robot-assisted training improves upperlimb function following stroke.

Methods/design

Study design: a pragmatic, three-arm, multicentre randomisedcontrolled 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 limbfunctional limitation.

Randomisation groups:

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

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

3. Usual NHS care in accordance with local clinical practice

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

Primary outcome: upper limb function measured by the ActionResearch 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 ImpactScale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverseevents, at 3 and 6 months.

Blinding: outcomes are undertaken by blinded assessors.

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

Process evaluation: semi-structured interviews withparticipants and professionals to seek their views and experiences of therehabilitation that they have received or provided, and factors affecting theimplementation of the trial.

Sample size: allowing for 10% attrition, 720 participantsprovide 80% power to detect a 15% difference in successful outcome between eachof the treatment pairs. Successful outcome definition: baseline ARAT 0–7 mustimprove 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 by6 or more points.

Discussion

The results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.

Trial registration

ISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.

Original languageEnglish
Article number340 (2017)
Number of pages16
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 20 Jul 2017

Keywords

  • stroke, arm, rehabilitation, robotics, RCT, cost-effectiveness analysis, parallel process evaluation

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