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

Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke, Multi-center, Randomized Controlled Pilot Study

The aim of this study is to evaluate the safety of gait training using a hip-assist powered exoskeleton. This will be assessed by collecting all device-related adverse events occurring during the entire intervention period, which consists of a total of 10 sessions within 5 weeks across two different gait rehabilitation protocols.

Inclusion Criteria:

1. Adults aged 19 to 85 years.

2. Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.

3. 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.

4. 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

5. 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)

6. Patients who have received approval for study participation from the attending medical staff.

Exclusion Criteria:

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