Feasibility and safety of multi-field functional electrical stimulation for distal upper-limb rehabilitation after subacute stroke: a randomised controlled feasibility trial
Abstract
Background: Functional electrical stimulation (FES) is recommended for upper-limb rehabilitation after stroke but remains underused in routine clinical practice. Multi-field FES may simplify clinical application and improve selective muscle activation, although evidence generated under real-world rehabilitation conditions remains limited.
Objective: To assess the feasibility, usability, and safety of multi-field FES for distal upper-limb rehabilitation after subacute stroke and to generate preliminary effect estimates to inform a future definitive trial.
Methods: We conducted a single-centre, parallel-group, randomised controlled feasibility trial with blinded outcome assessment. Sixteen adults with subacute stroke (≤6 months) and unilateral upper-limb impairment were randomised 1:1 to FES-assisted therapy or conventional rehabilitation (n = 8 per group). Both groups received two 40-minute upper-limb therapy sessions per week for 6 weeks (12 sessions); the experimental group received treatment using the Fesia Grasp multi-field stimulation device. Primary outcomes were retention, adherence, usability, motivation, and safety. Secondary exploratory outcomes included the Fugl-Meyer Assessment for Upper Extremity, modified Medical Research Council scale, grip strength, and Box and Block Test, assessed at baseline and post-intervention by blinded evaluators.
Results: Of 20 participants screened between April 2022 and August 2023, 16 were recruited and randomised (8 per group) and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
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