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.
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.
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.
The results from this trial will determine whetherrobot-assisted training improves upper limb function post stroke.
ISRCTN, identifier: ISRCTN69371850. Registered 4October 2013.
- stroke, arm, rehabilitation, robotics, RCT, cost-effectiveness analysis, parallel process evaluation