Abstract / Summary
Abstract Background Post-stroke gait asymmetry is associated with impaired paretic weight bearing, reduced walking stability, and increased fall risk. Stroke survivors with cognitive impairment may have greater difficulty with gait phase control because of reduced attentional allocation and sensorimotor integration. This assessor-blinded randomized controlled trial examined whether dorsal foot sensory electrical stimulation improves paretic stance-phase control in stroke survivors with cognitive impairment. Methods In this assessor-blinded, parallel-group randomized controlled trial, 50 hospitalized stroke survivors with cognitive impairment, defined as an education-adjusted Montreal Cognitive Assessment score < 26, and National Institutes of Health Stroke Scale scores < 5 were randomized 1:1 to dorsal foot sensory electrical stimulation plus conventional rehabilitation or sham-device control plus conventional rehabilitation. Both groups received conventional rehabilitation for 4 weeks, with stimulation administered 5 times weekly for 30 minutes. The primary outcome was paretic stance-phase percentage during normal walking. Linear mixed-effects models were used for longitudinal analyses. A complete-case sensitivity analysis adjusted for concurrent gait speed. Results Seventy-eight participants were screened and 50 were randomized, with 25 in each group. The paretic stance-phase percentage decreased from 68.85% to 60.59% in the stimulation group and from 69.46% to 64.78% in the control group. The group-by-time interaction was significant in the intention-to-treat model after multiple imputation (chi-square = 38.84, P < 0.001), and the between-group difference in change at week 4 was − 3.40 percentage points (95% CI, -4.49 to -2.31). After adjustment for concurrent gait speed in complete cases, the group-by-time interaction remained significant (chi-square = 15.79, P = 0.003). Single-support phase percentage and knee flexion peaks also improved more in the stimulation group. Conclusions Four weeks of dorsal foot sensory electrical stimulation combined with conventional rehabilitation improved abnormal paretic stance-phase distribution in stroke survivors with cognitive impairment, and this effect was not fully explained by increased gait speed. These findings support sensory-driven gait rehabilitation as a potential strategy for improving paretic weight-bearing participation and gait phase control. Trial registration Chinese Clinical Trial Registry, ChiCTR2400081558, registered 5 March 2024, before participant enrollment.