stroke
Conditions
Interventions
Closed-loop training group:None
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Stroke confirmed by CT or MRI findings together with clinical diagnostic records. 2.Stroke onset between 1 and 12 months before the index rehabilitation period, during the recovery or early chronic stage, with lower-limb motor dysfunction. 3.Aged 18 to 75 years. 4.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. 5.Receipt of conventional lower-limb rehabilitation alone, or closed-loop brain-computer interface exoskeleton robot combined with virtual reality training in addition to conventional rehabilitation, during hospitalization in the rehabilitation department. 6.Availability of a baseline FMA-LE assessment and at least one post-baseline FMA-LE assessment. The primary endpoint analysis requires both baseline and week-6 FMA-LE assessments. 7.For EEG-related analyses, availability of usable EEG recordings, task markers, and data suitable for basic preprocessing.
Exclusion criteria
Exclusion criteria: 1.Documented disturbance of consciousness, severe cognitive impairment such as MMSE <21, inability to understand instructions or cooperate with assessments, severe aphasia, agnosia, apraxia, or psychiatric disorders preventing completion of basic rehabilitation assessments. 2.Severe cardiopulmonary disease, severe musculoskeletal deformity, high fracture risk, or another condition that substantially compromises the safety of standing training. 3.Skin ulceration, damage, or infection in areas contacting the exoskeleton that interferes with training. 4.Severe spasticity of the affected lower limb, defined as a Modified Ashworth Scale score of at least 3, that interferes with training or assessment. 5.Lower-limb deep vein thrombosis or another high-risk peripheral vascular condition within the previous 3 months. 6.Previous receipt of other intensive robotic, brain-computer interface, or virtual reality training that could substantially affect lower-limb recovery and could not be distinguished from the exposure of interest. 7.Severe absence of key data preventing determination of treatment group, primary outcome, or major confounding variables.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FMA-LE score from baseline to week 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Modified Barthel Index score; | — |
Countries
China
Contacts
Public ContactYang Zhang
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed