BCIwiki (bciwiki.com) — A retrospective cohort study has been registered with the Chinese Clinical Trial Registry (ChiCTR) to examine the association between closed-loop brain-computer interface exoskeleton rehabilitation and lower-limb functional recovery in stroke patients. The registration number is ChiCTR2600131872, dated September 7, 2026. The primary sponsor is the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, with the Department of Rehabilitation Medicine listed as the contact affiliation.
The observational cohort study plans to enroll 58 patients in a closed-loop training group and 57 in a conventional rehabilitation group. Recruitment is listed as pending, with the country of recruitment being China. First enrolment is dated September 7, 2026, and the registration is prospective. Eligible participants are aged 18 to 75, of any gender, with stroke confirmed by CT or MRI findings and clinical diagnostic records, stroke onset between 1 and 12 months before the index rehabilitation period during the recovery or early chronic stage, and lower-limb motor dysfunction.
Patients must have partial preservation of motor function in the affected lower limb, with a documented Brunnstrom stage of at least II or lower-limb muscle strength of at least grade 2. They must have received conventional lower-limb rehabilitation alone, or closed-loop BCI exoskeleton robot combined with virtual reality training in addition to conventional rehabilitation, and must have a baseline FMA-LE assessment plus at least one post-baseline FMA-LE assessment; the primary endpoint analysis requires both baseline and week-6 FMA-LE assessments. For EEG-related analyses, usable EEG recordings, task markers and data suitable for basic preprocessing are required.
Exclusion criteria cover documented disturbance of consciousness, severe cognitive impairment such as MMSE below 21, inability to understand instructions or cooperate with assessments, severe aphasia, agnosia, apraxia or psychiatric disorders; severe cardiopulmonary disease, severe musculoskeletal deformity, high fracture risk or other conditions compromising the safety of standing training; skin ulceration, damage or infection at exoskeleton contact areas; severe spasticity with a Modified Ashworth Scale score of at least 3; lower-limb deep vein thrombosis or another high-risk peripheral vascular condition within the previous 3 months; previous intensive robotic, BCI or virtual reality training that could substantially affect lower-limb recovery; and severe absence of key data.
The primary outcome is change in FMA-LE score from baseline to week 6. Secondary outcomes include the 10-Meter Walk Test result, motor imagery-related electroencephalographic features, Berg Balance Scale score, Timed Up and Go test result, FMA-LE scores over time, rehabilitation-related adverse events and training interruptions, lower-limb muscle strength, lower-limb surface electromyographic features, affected lower-limb muscle circumference and Modified Barthel Index score. The study is self-funded by the research team.
The registration page provides only bibliographic and design fields, with no results data and no device models or actual enrollment figures. The registration record was last updated on September 14, 2026.