A Study to Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients: An Investigator-Initiated, Single-Center, Single-Arm Exploratory Trial
Sponsor: Yonsei University
Trial Details
| Condition | Stroke |
| Intervention | hip-assisted wearable robot |
| Phase | NA |
| Status | Recruiting |
| Participants | 8 |
| Est. Completion | 30 Sept 2026 |
| Last Updated | 21 July 2026 |
Primary Outcome
Telehealth Usability Questionnaire (TUQ)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Adults aged 19 years or older and under 80 years 2. Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography 3. Persons for whom at least 1 month has elapsed since the diagnosis of stroke 4. Persons showing a spastic hemiplegic gait pattern due to stroke 5. Patients with a Functional Ambulatory Category score below 4 6. Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance 7. Persons with sufficient cognitive ability to follow simple instructions and understand the content and purpose of the study (Mini-Mental State Examination score \>= 20) Exclusion Criteria: 1. Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture 2. Persons for whom wearing the device is difficult due to skin disease or open wounds 3. Persons with a severe difference in the length of the two lower extremities 4. Persons with severe deformity or joint contracture in the lower extremities 5. Persons unable to maintain a sitting posture or a standing posture on their own 6. Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher) 7. Persons who cannot cooperate with gait therapy using the robot-assisted orthopedic exercise device due to severe cognitive decline (Mini-Mental State Examination score \< 20), delirium, or severe language function impairment 8. Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function 9. Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes 10. Pregnant women or patients with the possibility of pregnancy 11. Persons currently participating in another clinical trial 12. Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like 13. Persons with a height less than 140 cm or greater than 190 cm 14. Persons for whom wearing the robot is not possible 15. Persons with clinically significant findings that, in the medical judgment of the principal investigator or a sub-investigator, are considered inappropriate for this study other than the above
Trial Sites
Countries
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