Title: Robot Assisted Training for the Upper Limb after Stroke (RATULS).
Chief Investigator: Professor Helen Rodgers.
Sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust.
Funder: NIHR HTA programme (ref: 11/26/05).
Study design: A pragmatic multicentre randomised controlled trial; cost analysis and process evaluation.
Study setting: NHS stroke services. There are four study centres (North Tyneside General Hosptial, Northwick Park Hospital, Queen Elizabeth University Hopsital Glasgow and Queen's Hospital Romford), each consisting of a hub site with an InMotion robotic gym system and adjacent stroke services which act as spoke sites.
Study participants: Adults with acute or chronic first ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation.
Study treatments:There are three randomisation groups:
i. Robot assisted training using the InMotion robotic gym system
ii. Enhanced upper limb therapy
Randomisation: Individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment via an independent randomisation service.
Primary outcome: Upper limb function measured by the Action Research Arm Test (ARAT) at three months post randomisation.
Secondary outcomes: Upper limb impairment, activities of daily living, quality of life, resource use and adverse events measured at three and six months post randomisation.
Blinding: Outcomes assessments are undertaken by a blinded assessor.
Parallel qualitative process evaluation: Semi-structured interviews with a subsample of study participants and staff will be conducted to gain insight into their perceptions and experience of robot assisted training, enhanced upper limb therapy and usual care.
Sample size: 762 participants
Study duration: 57 months.
The study is now closed to recruitment.
You can view the published study protocol here.
The enhanced upper limb therapy manauls are available here:
RATULS Enhanced upper limb therapy 1 programme overview v3 040815
RATULS Enhanced upper limb therapy 2 how to deliver the therapy programme v4 040815