Bilateral Transcutaneous Electrical Nerve Stimulation Improves Upper Limb Motor Recovery in Stroke: A Randomized Controlled Trial
Background and Purpose: Recent evidence has shown bilateral transcutaneous electrical nerve stimulation (Bi-TENS) combined with task-oriented training (TOT) to be superior to unilateral transcutaneous electrical nerve stimulation (Uni-TENS)+TOT in improving lower limb motor functioning following stroke. However, no research explored the effect of Bi-TENS+TOT in improving upper limb motor recovery. This study aimed to compare Bi-TENS+TOT with Uni-TENS+TOT, Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)+TOT, and no treatment (Control) groups in upper limb motor recovery. Methods: This is a 4-group parallel design. One hundred and twenty subjects were given either Bi-TENS+TOT, Uni-TENS+TOT, Placebo-TENS+TOT, or Control without treatment in this randomized controlled trial. Twenty 60-minute sessions were administered 3× per week for 7 weeks. The outcome measure was the Fugl-Meyer Assessment of Upper Extremity, which was assessed at baseline, after 10 sessions (mid-intervention) and 20 sessions (post-intervention) of intervention, and at 1- and 3-month follow-up. Results: Patients in the Bi-TENS+TOT group showed greater improvement in the Fugl-Meyer Assessment of Upper Extremity scores than Uni-TENS+TOT (mean difference, 2.13; P =0.004), Placebo-TENS+TOT (mean difference, 2.63; P <0.001), and Control groups (mean difference, 3.11; P <0.001) at post-intervention. Both Bi-TENS+TOT (mean difference, 3.39; P <0.001) and Uni-TENS+TOT (mean difference, 1.26; P =0.018) showed significant within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores. Patients in the Bi-TENS+TOT group showed earlier within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores at mid-intervention than Uni-TENS+TOT. These improvements were maintained at the 3-month follow-up assessment. Conclusions: Bi-TENS combined with TOT is an effective therapy for improving upper limb motor recovery following stroke. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03112473.