BCIwiki (bciwiki.com) — The Second Affiliated Hospital of Xi'an Jiaotong University has registered a multicenter, prospective, randomized controlled trial in the Chinese Clinical Trial Registry to assess central-peripheral-central closed-loop brain-computer interface ankle rehabilitation training for lower limb functional reconstruction in stroke patients. The registration number is ChiCTR2600125418, the registration date is May 26, 2026, recruitment status is not yet recruiting, and first enrolment is set for May 31, 2026.
The trial uses a parallel design and plans to enroll 120 participants, 60 in the experimental group and 60 in the control group. The experimental group receives 4 weeks of central-peripheral-central closed-loop BCI ankle rehabilitation training; the control group receives 4 weeks of conventional active and passive ankle training. Participants must be 45 to 75 years old, of either sex, and are being recruited in China.
Inclusion criteria require patients to be in the subacute phase of stroke, 4 to 12 weeks after onset, with stable vital signs and neurological function; to have definite unilateral ankle motor dysfunction, clinically manifested as foot drop and/or varus during the swing phase of gait, with absolute active dorsiflexion range of motion of the affected ankle below 10 degrees; to have a Brunnstrom stage of III for the affected lower limb and be able to stand for at least 30 seconds with or without assistance; and to score at least 24 on the Mini-Mental State Examination.
The primary endpoints are active ankle dorsiflexion range of motion and Manual Muscle Testing of the ankle. Secondary endpoints include Functional Ambulation Classification, the Berg Balance Scale and the Fugl-Meyer Motor Assessment of the Lower Limb. Funding comes from a horizontal project, and the registry record was last updated on June 1, 2026.
The registry entry does not list a specific BCI device model or actual enrolment numbers; only bibliographic and design fields are posted, with no results data yet.