Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with unilateral limb paralysis caused by a first-ever clinical stroke and with a disease course of less than 6 months; 2.Subjects aged >18 years and 150 cm and =190 cm. 4.Normal gait prior to the first-ever stroke. 5.Functional Ambulation Category (FAC) score 3 minutes. 7.Able to cooperate with and complete the assessments. 8.Has provided informed consent and signed the study consent form.
Exclusion criteria
Exclusion criteria: 1.Unstable basic vital signs, unsuitable for rehabilitation training. 2.Presence of hemispatial neglect and/or pusher syndrome and/or walking apraxia. 3.Cardiac dysfunction (New York Heart Association functional class > III) and/or malignant arrhythmia. 4.Lower-limb swelling and pain caused by deep-vein thrombosis. 5.Marked limitation of lower-limb joint range of motion, defined as: - Passive hip extension 40°. 8.Presence of bone or joint tumors, deformities, or lower-limb amputation . 9.Lower-limb fracture that has not yet met the clinical criteria for union . 10.Presence of skin lesions in the areas corresponding to the device-binding straps or interfaces . 11.Severe lower-limb spasticity (Modified Ashworth Scale grade 4 in any lower-limb joint); 12.Subject is pregnant. 13.Has participated or is concurrently participating in any other clinical trial within 30 days. 14.No claustrophobia and no contraindications for MRI (e.g., cardiac pacemaker, intra-ocular metal foreign body, aneurysm clipped with silver ligature, or any implanted metal foreign body). 15.No history of substance abuse or psychiatric disorder. 16.The investigator considers the subject unsuitable for this clinical trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FAM; | — |
Secondary
| Measure | Time frame |
|---|---|
| 10MWT;DTI-derived microstructural indices of white-matter fiber tract;6MWT;FM- LE;BBS;TIS;fMRI-fALFF; | — |
Countries
China
Contacts
Beijing Bo'ai Hospital