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Penetrating needling from Qiuxu (GB40) to Zhaohai (KI6) versus separate needling for post-stroke lower-limb motor dysfunction: an assessor-blinded randomized controlled trial protocol

Year: 2026

Type: article

Abstract: Post-stroke lower-limb motor dysfunction limits mobility, balance, and independence and remains a major target of neurorehabilitation. Acupuncture is widely used as an adjunctive intervention after stroke, but direct randomized evidence comparing penetrating needling with conventional separate needling at the same acupoints is limited. This protocol describes an active-comparator randomized controlled trial comparing penetrating needling from Qiuxu (GB40) to Zhaohai (KI6) with separate needling for post-stroke lower-limb motor dysfunction, with functional near-infrared spectroscopy (fNIRS) and surface electromyography (sEMG) included as exploratory mechanistic outcomes. This single-center, prospective, assessor-blinded, parallel-group superiority trial will enroll 130 participants with subacute post-stroke lower-limb motor dysfunction. Participants will be randomized 1:1 to penetrating needling from Qiuxu (GB40) to Zhaohai (KI6) or to separate needling at the same acupoints. Both groups will receive 12 acupuncture sessions over 2 weeks, delivered 6 times per week, with 30 min of needle retention per session, together with the same total rehabilitation dose of 30 min/day, 5 days/week. The primary outcome is the Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score at the end of treatment (T1). The primary analysis will use analysis of covariance adjusted for baseline FMA-LE. Secondary clinical outcomes include the Berg Balance Scale, Manual Muscle Testing, and Modified Ashworth Scale. Registered secondary neurophysiological assessments include fNIRS and sEMG; their derived measures will be analyzed exploratorily. Clinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/project/view/2037483478790045696, ITMCTR2026000773.

Source: Frontiers in Neurology

DOI: 10.3389/fneur.2026.1911011