80ROBOT ASSISTED TRAINING FOR THE UPPER LIMB AFTER STROKE (RATULS) TRIAL: STUDY PROGRESS

Abstract

Background and Aims: Robot-assisted training is a promising treatment for upper limb recovery following stroke. The RATULS trial is the largest trial to date to determine whether robot-assisted training improves upper limb function post stroke. Recruitment commenced 14.4.14 and here we report recruitment, attrition and intervention adherence to 15.12.17. Method: A multi-centre randomised controlled trial, cost effectiveness analysis and process evaluation. Inclusion criteria: Adults 1 week-5 years post first ever stroke, with moderate or severe arm weakness (Action Research Arm Test (ARAT) 0-39). Randomisation groups: i. Robot-assisted training using the InMotion robotic gym system for 45 minutes, three times per week for 12 weeks (27 hours). ii. Enhanced upper limb therapy provided by a therapy assistant, supervised by a therapist for 45 minutes, three times per week for 12 weeks (27 hours). iii. Usual NHS care. Outcomes are measured by a blinded assessor at 3 and 6 months. The primary outcome is the ARAT at 3 months. Target sample size is 762. Results: Four study centres have recruited 713 participants, median age 61 years [IQR 51-79], 432 (61%) male, median time since stroke 248 days [IQR 114-556], median baseline ARAT 3 [IQR 0-12]. Three and 6 month outcome data are available for 584/663 (88%) and 517/624 (83%). 221 participants have concluded robot-assisted training and attended 6967/ 7956 (88%) sessions. 228 participants have concluded enhanced upper limb therapy and attended 6839/8208 (83%) sessions. Conclusion: The RATULS trial results will be available mid 2019.