SMART Arm Training With Outcome-Triggered Electrical Stimulation in Subacute Stroke Survivors With Severe Arm Disability: A Randomized Controlled Trial

Background. Stroke survivors with severe upper limb disability need opportunities to engage in task-oriented practice to achieve meaningful recovery. Objective. To compare the effect of SMART Arm training, with or without outcome-triggered electrical stimulation to usual therapy, on arm function for stroke survivors with severe upper limb disability undergoing inpatient rehabilitation. Methods. A prospective, multicenter, randomized controlled trial was conducted with 3 parallel groups, concealed allocation, assessor blinding and intention-to-treat analysis. Fifty inpatients within 4 months of stroke with severe upper limb disability were randomly allocated to 60 min/d, 5 days a week for 4 weeks of (1) SMART Arm with outcome-triggered electrical stimulation and usual therapy, (2) SMART Arm alone and usual therapy, or (3) usual therapy. Assessment occurred at baseline (0 weeks), posttraining (4 weeks), and follow-up (26 and 52 weeks). The primary outcome measure was Motor Assessment Scale item 6 (MAS6) at posttraining. Results. All groups demonstrated a statistically (P < .001) and clinically significant improvement in arm function at posttraining (MAS6 change >= 1 point) and at 52 weeks (MAS6 change >= 2 points). There were no differences in improvement in arm function between groups (P = .367). There were greater odds of a higher MAS6 score in SMART Arm groups as compared with usual therapy alone posttraining (SMART Arm stimulation generalized odds ratio [GenOR] = 1.47, 95%CI = 1.23-1.71) and at 26 weeks (SMART Arm alone GenOR = 1.31, 95% CI = 1.05-1.57). Conclusion. SMART Arm training supported a clinically significant improvement in arm function, which was similar to usual therapy. All groups maintained gains at 12 months.