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
4 affiliations
- 1First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- 2National Clinical Research Center for Chinese Medicine
- 3Tianjin Medical University General Hospital
- 4Department of Physical and Rehabilitation Medicine, Tianjin Medical University General Hospital
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.
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BibTeX
@article{zhang2026penetrating,
title = {{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}},
author = {Jie Zhang and Lin Wang and Zhen Tian and Meng Wang and Jing Fan and Xiaoxiao Liu and Chao Cui and Yulin Qian and Rui Zhang and Yi Liu and Chunxiao Wan},
journal = {Frontiers in Neurology},
year = {2026},
month = oct,
doi = {10.3389/fneur.2026.1911011},
url = {https://www.frontiersin.org/articles/10.3389/fneur.2026.1911011/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Jie Zhang
AU - Lin Wang
AU - Zhen Tian
AU - Meng Wang
AU - Jing Fan
AU - Xiaoxiao Liu
AU - Chao Cui
AU - Yulin Qian
AU - Rui Zhang
AU - Yi Liu
AU - Chunxiao Wan
PY - 2026
DA - 2026/10/21
JO - Frontiers in Neurology
DO - 10.3389/fneur.2026.1911011
UR - https://www.frontiersin.org/articles/10.3389/fneur.2026.1911011/full
AB - 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.
SN - 1664-2295
ER -