BCIwiki (bciwiki.com) — A randomized controlled trial of BCI-assisted lower limb exoskeleton rehabilitation has been registered with the Chinese Clinical Trial Registry (ChiCTR) under number ChiCTR2600125531, with a registration date of May 28, 2026. Punan Hospital, Pudong New Area, Shanghai is the sponsor. The trial plans to enroll 60 participants, 30 in the intervention group and 30 in the control group, with first enrolment set for May 30, 2026. The registration lists the recruitment status as not yet recruiting.
The trial will enroll patients aged 18 to 75 whose stroke or spinal cord injury occurred at least 3 months earlier and who are in a stable recovery phase, with confirmed lower limb motor impairment and a Fugl-Meyer Assessment lower extremity score below 24. Participants must be conscious, with a Mini-Mental State Examination score of at least 24. The intervention group receives BCI-assisted lower limb exoskeleton rehabilitation training, while the control group receives conventional walking training, in a parallel-group interventional design.
Primary outcomes include surface electromyography signals of the lower limb muscle groups, lower limb motor function, the Modified Barthel Index, a balance scale and functional ambulation. The secondary outcome is an equipment usage feedback and satisfaction scale. Funding comes from a clinical research project approved under the Health Commission of Pudong New Area. The registration page carries only bibliographic and design fields; specific device models and actual enrolment numbers are not listed.