Cardiovascular

Comparison of Continuous and Gait-synchronized Transcutaneous Electrical Nerve Stimulation During Gait Training in Chronic Stroke: A Pilot Randomized Trial.

TL;DR

Continuous and gait-synchronized TENS combined with standardized gait training were feasible and well tolerated in individuals with chronic stroke, but the adjusted analysis did not provide robust evidence of differential clinical effects among stimulation-timing groups after correction for multiple outcome testing.

Key Findings

Intervention adherence was high and no adverse events were reported across all stimulation conditions.

  • 99% of scheduled sessions were completed across all groups
  • No intervention-related adverse events were reported
  • One participant withdrew before intervention without baseline assessment, resulting in 23 participants in the mITT analysis
  • 24 participants were originally randomized to continuous stimulation (CS), gait-synchronized stimulation (GS), or sham stimulation

Comfortable gait speed showed no significant group × time interaction among the three stimulation conditions.

  • Comfortable gait speed was the primary longitudinal outcome assessed using baseline-adjusted linear mixed-effects models
  • No significant group × time interaction was detected for comfortable gait speed
  • Analysis was conducted in the modified intention-to-treat (mITT) population of 23 participants
  • Outcomes were assessed at baseline, post-intervention, and 8-week follow-up

Maximal gait speed and Berg Balance Scale showed nominal group × time interaction effects that did not survive false discovery rate correction.

  • Nominal group × time interaction effects were observed for maximal gait speed and Berg Balance Scale before statistical correction
  • These effects did not remain significant after false discovery rate (FDR) correction was applied to group × time interaction p-values across estimable outcomes
  • No robust group × time interaction effects were observed after FDR correction
  • Exploratory per-protocol analyses were unadjusted for baseline imbalance and were interpreted as supportive only

Gait-synchronized TENS delivered stimulation according to stance and swing phases, distinguishing it from continuous non-phase-specific stimulation.

  • CS (continuous stimulation) delivered non-phase-specific stimulation throughout gait training
  • GS (gait-synchronized stimulation) delivered stimulation according to stance and swing phases of the gait cycle
  • A sham stimulation condition served as a control
  • All participants received 12 intervention sessions over 4 weeks of standardized gait training
  • The rationale was that post-stroke gait dysfunction may involve impaired integration of motor commands, somatosensory feedback, and phase-dependent peripheral sensory input during locomotion

The pilot trial did not provide robust evidence that timing of TENS stimulation differentially affects clinical outcomes in chronic stroke gait rehabilitation.

  • The primary longitudinal analysis used baseline-adjusted linear mixed-effects models in the mITT population
  • FDR correction was applied to group × time interaction p-values across estimable outcomes
  • After correction, no robust group × time interaction effects were observed
  • The authors concluded that larger, adequately powered trials are needed to determine whether continuous or gait-synchronized TENS provides clinically meaningful benefits

What This Means

This research suggests that using electrical nerve stimulation (TENS) during walking rehabilitation after stroke is safe and practical, regardless of whether the stimulation is delivered continuously or timed to match the phases of the walking cycle. In this small pilot study, 24 people with chronic stroke were randomly assigned to receive one of three conditions during standardized walking training over 4 weeks: constant electrical stimulation, stimulation timed to their walking phases (stance and swing), or fake stimulation. Nearly all scheduled sessions were completed and no harmful side effects occurred in any group. However, when the researchers rigorously analyzed whether one type of stimulation produced better walking or balance outcomes than another, they found no convincing differences after accounting for the multiple outcomes being tested. Some measures like maximum walking speed and balance scores showed hints of differences between groups before statistical correction, but these hints disappeared once the analysis was adjusted to reduce the chance of false positives. The primary measure — comfortable walking speed — showed no meaningful difference among the three groups. This research suggests that while TENS combined with gait training appears safe and acceptable for people recovering from stroke, this small pilot study was not able to demonstrate that the timing of stimulation matters for rehabilitation outcomes. The findings highlight the need for larger studies with more participants to properly test whether either form of TENS — continuous or walking-phase-synchronized — offers real benefits over sham stimulation during post-stroke walking rehabilitation.

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Citation

Na J, Song M, Park H, Choi I, Lee J, Yoon J, et al.. (2026). Comparison of Continuous and Gait-synchronized Transcutaneous Electrical Nerve Stimulation During Gait Training in Chronic Stroke: A Pilot Randomized Trial.. Revista de neurologia. https://doi.org/10.31083/RN53766