SMART Arm with Outcome-Triggered Electrical Stimulation: A Pilot Randomized Clinical Trial

Background: The SMART (SensoriMotor Active Rehabilitation Training) Arm is a nonrobotic device designed to allow stroke survivors with severe paresis to practice reaching. It can be used with or without outcome-triggered electrical stimulation (OT-stim) to augment movement. The aim of this study was to evaluate the efficacy of SMART Arm training when used with or without OT-stim, in addition to usual care, as compared with usual care alone during inpatient rehabilitation. Methods: Eight stroke survivors received 20 hours of SMART Arm training over 4 weeks; they were randomly assigned to either (1) SMART Arm training with OT-stim or (2) SMART Arm training alone. Usual therapy was also provided. A historical cohort of 20 stroke survivors formed the control group and received only usual therapy. The primary outcome was Motor Assessment Scale Item 6, Upper Arm Function. Results: Findings for all participants were comparable at baseline. SMART Arm training, with or without OT-stim, led to a significantly greater improvement in upper arm function than usual therapy alone (P=.024). There was no difference in improvement between training with or without OT-stim. Initial motor severity and presence of OT-stim influenced the number of repetitions performed and the progression of SMART Arm training practice conditions. Conclusion: Usual therapy in combination with SMART Arm training, with or without OT-stim, appears to be more effective than usual therapy alone for stroke survivors with severe paresis. These findings warrant further investigation into the benefits of SMART Arm training for stroke survivors with severe paresis undergoing inpatient rehabilitation during the subacute phase of recovery.