Background: Robotic systems combined with Functional Electrical Stimulation (FES) showed promising results on upper-limb motor recovery after stroke, but adequately-sized randomized controlled trials (RCTs) are still missing.
Objective: To evaluate whether arm training supported by RETRAINER, a passive exoskeleton integrated with electromyograph-triggered functional electrical stimulation, is superior to advanced conventional therapy (ACT) of equal intensity in the recovery of arm functions, dexterity, strength, activities of daily living, and quality of life after stroke.
Methods: A single-blind RCT recruiting 72 patients was conducted. Patients, randomly allocated to 2 groups, were trained for 9 weeks, 3 times per week: the experimental group performed task-oriented exercises assisted by RETRAINER for 30 minutes plus ACT (60 minutes), whereas the control group performed only ACT (90 minutes). Patients were assessed before, soon after, and 1 month after the end of the intervention. Outcome measures were as follows: Action Research Arm Test (ARAT), Motricity Index, Motor Activity Log, Box and Blocks Test (BBT), Stroke Specific Quality of Life Scale (SSQoL), and Muscle Research Council.
Results: All outcomes but SSQoL significantly improved over time in both groups (P < .001); a significant interaction effect in favor of the experimental group was found for ARAT and BBT. ARAT showed a between-group change of 11.5 points (P = .010) at the end of the intervention, which increased to 13.6 points 1 month after. Patients considered RETRAINER moderately usable (System Usability Score of 61.5 ± 22.8).
Conclusions: Hybrid robotic systems, allowing to perform personalized, intensive, and task-oriented training, with an enriched sensory feedback, was superior to ACT in improving arm functions and dexterity after stroke.
Trial registration: ClinicalTrials.gov NCT03171649.
Keywords: arm; exoskeleton; functional electrical stimulation; randomized controlled trial; rehabilitation; stroke.