For Healthcare Professionals

RATULS study summary:

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

iii. Usual NHS rehabilitation

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 currently open to recruitment.

For further information about the trial, feel free to contact us at ratuls@ncl.ac.uk

You can also now view the published study protocol here.