Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07353203
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT07353203
Study Brief:
Protocol Section:
NCT07353203