Plantar Needle-pricking for Early Lower-Limb Recovery After Stroke via the Nociceptive Withdrawal Reflex: Assessor-Blinded Randomized Trial.

This assessor-blinded randomized controlled trial evaluated whether a standardized plantar needle-pricking protocol designed to evoke the nociceptive withdrawal reflex (NWR) improves early lower-limb motor recovery in post-stroke flaccid hemiplegia. Eighty patients were randomized (1:1) to receive either NWR-evoking plantar needle-pricking plus standardized rehabilitation or standardized rehabilitation alone for 6 consecutive days; 76 participants completed outcome assessments (38 per group). Primary outcomes were Brunnstrom stage and the Fugl-Meyer Assessment of the Lower Extremity (FMA-LE). By day 6, the pricking group demonstrated a greater shift in Brunnstrom stage distribution (P = 0.03; Cramér's V = 0.31, 95% CI 0.14-0.48) and a larger median Brunnstrom stage change from baseline (1 [0-1] vs. 0 [0-1]; P = 0.013; effect size r = 0.29, 95% CI 0.06-0.48). FMA-LE total score at day 6 was higher in the pricking group (16 [12-19] vs. 11 [8-14]; P < 0.01; effect size r = 0.38, 95% CI 0.17-0.56). Secondary outcomes favored the pricking group for lower-limb active range of motion, manual muscle strength, and knee flexor tone (all P < 0.05). Outcome assessors guessed allocation at a rate not different from chance (52.6%; P = 0.68). One participant experienced mild local bruising that resolved without intervention; no serious adverse events occurred. This protocol provides a reproducible, safety-annotated approach for reflex-based early lower-limb rehabilitation after stroke.