Feasibility and safety of multi-field functional electrical stimulation for distal upper-limb rehabilitation after subacute stroke: a randomised controlled feasibility trial.

No formal sample size calculation was performed; the study was a small feasibility trial with 16 participants, so it was not designed to establish clinical efficacy and the exploratory effect estimates were imprecise. The control group was older on average (71.1 vs 62.8 years), and one participant was 90 years; this imbalance may have inflated differences favouring the FES group. Participants and therapists were not blinded, so self-reported usability and motivation could have been affected by expectancy or social desirability. The FES group received FES within a broader therapy session that also included task practice and ADL-oriented training, so the contribution of stimulation alone cannot be separated. The device-specific usability questionnaire was not formally validated, and exact active stimulation time and session-level parameters were not prospectively recorded. There was no longer-term follow-up or activity-level outcome such as the ARAT or WMFT, so durability and daily-life impact were not assessed. Recruitment occurred in two periods separated by about 5 months, although sensitivity analyses adjusting for period gave generally similar estimates. The mMRC ordinal scale was treated as approximately continuous for exploratory analysis.

The authors declared that no financial support was received for the work. Fesia Technology provided the device and technical/software support, but its personnel had no contact with participants and no role in supervising or delivering therapy sessions.

Do not conclude that stimulation alone caused the motor differences. The FES group also received task practice and ADL-oriented training within the same session, so the contribution of any single component cannot be separated. This was also a small feasibility trial not designed to establish efficacy.