Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke

Inclusion criteria

• Adults aged 19 to 85 years.
• Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.
• Patients in the late subacute or chronic phase, with stroke onset of 3 months or more (in cases of recurrent stroke, based on the most recent event). Functional Ambulation Category (FAC) score of 3 or higher.
• Patients capable of safely wearing the hip-assist powered exoskeleton and using it with minimal assistance.

• Height: 140 cm - 190 cm
• Weight: 80 kg or less
• Patients who were capable of independent walking and had no disability in daily self-care activities prior to stroke onset (based on the last stroke for recurrent patients). (mRS ≤2)
• Patients who have received approval for study participation from the attending medical staff.

Exclusion criteria

• Severe cognitive impairment (Mini-Mental State Examination [MMSE] < 10) or severe speech impairment/aphasia.
• History of major orthopedic surgery, such as hip, knee, or ankle arthroplasty, within the last 3 months.
• Fractures, open wounds, or unhealed ulcers in the lower extremities.
• Patients for whom gait training with the powered orthopedic device is difficult due to severe medical conditions, such as cardiovascular or pulmonary diseases.
• History of osteoporotic fractures.
• Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).
• Any other cases where the investigator deems participation in the study to be inappropriate.