BCIwiki (bciwiki.com) — A multicenter, prospective, randomized controlled trial has been registered with the Chinese Clinical Trial Registry to assess how BCI-driven active and passive lower limb training affects lower limb motor function and walking ability in stroke patients. The registration number is ChiCTR2600125377, the registration date is May 26, 2026, and recruitment status is not yet recruiting. The sponsor is The Second Affiliated Hospital of Xi'an Jiaotong University.
The trial plans to enroll 222 participants, 111 in the experimental group and 111 in the control group, with China as the recruiting country. Eligible patients are 45 to 75 years old, 1 to 3 months past their first ischemic or hemorrhagic stroke, with lesions in the cortex or subcortex confirmed by cranial CT or MRI and motor dysfunction of the affected lower limb at Brunnstrom stage II to IV. They must score at least 24 on the Mini-Mental State Examination and be able to understand and follow simple verbal instructions. Exclusions include other neurological diseases that could cause lower limb dysfunction, severe joint contracture or unhealed fracture of the affected limb, skull defect, ulcer or infection at the EEG acquisition site, and severely increased muscle tone with a Modified Ashworth Scale score of 3 or higher.
The experimental group will receive 4 weeks of motor imagery-based BCI-driven active and passive lower limb training, while the control group will receive 4 weeks of conventional active and passive lower limb training. The primary outcome is the Fugl-Meyer Assessment Lower Extremity Section; secondary outcomes are the Berg Balance Scale, the Modified Barthel Index and the Functional Ambulation Classification. First enrolment is dated May 31, 2026, and the registration record was last updated on June 1, 2026. Funding comes from a horizontal project. The registration page carries only bibliographic and design fields, with no results data and no device model or actual enrolment figures.