Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial

Abstract

Objective: The aim of this study was to assess the effects of applying transcranial direct-current stimulation (tDCS), a footdrop stimulator (FDS), and gait training simultaneously on functional mobility in people with chronic hemiparesis after stroke.

Methods: In this double-blind controlled trial, 32 individuals with mild, moderate, and severe chronic hemiparesis after stroke were randomized to tDCS plus FDS or sham tDCS plus FDS groups. Both groups underwent 10 concurrent tDCS and FDS gait training sessions 5 times per week for 2 weeks. Functional mobility was evaluated by the Timed "Up & Go" test (TUG). Secondary outcomes included spasticity of plantarflexors, knee extensors, and hip adductors; quality of life; and walking endurance (distance covered during each treadmill gait training session). Clinical assessments were performed before treatment, after treatment, and at a 1-month follow-up. A generalized estimating equation was used to compare the effects of time, group, and time × group interaction.

Results: No difference between groups was observed during performance of the TUG or other outcomes. TUG performance was improved in both the tDCS plus FDS group (before treatment = 24.29 [95% CI = 17.72-33.28]; after treatment = 21.75 [95% CI = 15.75-30.08]) and the sham tDCS plus FDS group (before treatment = 19.63 [95% CI = 16.06-23.0]; after treatment = 18.45 [95% CI = 15.26-22.3]). This improvement remained at the follow-up evaluation. Both groups also showed reduced spasticity of plantarflexors and knee extensors, increased quality of life, and increased total distance walked.

Conclusion: This study provided no evidence that bicephalic tDCS improves functional mobility, spasticity, quality of life, or walking endurance in people with chronic hemiparesis after stroke.

Impact: Bicephalic tDCS does not add relevant benefits to FDS and gait training in people who have chronic hemiparesis after stroke. Given that tDCS has few additional effects and given its costs for clinical practice, tDCS for rehabilitation in people with chronic hemiparesis after stroke is discouraged. FDS and gait training improve functional mobility, walking resistance, and quality of life in people with chronic hemiparesis after stroke.

Trial registration: ClinicalTrials.gov NCT04077814.

Keywords: Functional Electrical Stimulation; Neuromodulation; Stroke Rehabilitation; Transcranial Direct-Current Stimulation.