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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06543758
Eligibility Criteria:
Inclusion Criteria:
1. adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
2. individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
3. patients who have passed at least one month since stroke diagnosis.
4. individuals exhibiting spastic hemiplegic gait patterns due to stroke.
5. patients with a Functional Ambulatory Category score of less than 4.
6. individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
7. individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)
Exclusion Criteria:
1. individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
2. individuals with skin conditions or open wounds that prevent device usage.
3. individuals with significant differences in leg length.
4. individuals with severe deformities or joint contractures in the lower limbs.
5. individuals at high risk of fractures due to conditions like osteoporosis.
6. individuals unable to maintain a sitting or standing position independently.
7. individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
8. individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training.
9. individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
10. individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
11. pregnant women or those who could become pregnant.
12. individuals participating in other clinical trials.
13. individuals at high risk of falls or bleeding due to conditions like coagulopathies.
14. individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
15. individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT06543758
Study Brief:
Protocol Section:
NCT06543758