None listed
Conditions
Interventions
Medical Device : The study will include only a single test group, and a total of 16 participants will be included. The overall process of selecting a target group for gait training and using a robot-a
Sponsors
Yonsei University Yongin Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 79 years. 2) Individuals diagnosed with cerebral infarction or intracerebral hemorrhage identified by magnetic resonance imaging (MRI) or computed tomography (CT). 3) Individuals diagnosed with a stroke more than one month prior. 4) Individuals exhibiting a rigid hemiplegic walking pattern due to stroke. 5) Patients with a Functional Ambulatory Category (FAC) 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 capable of following simple instructions and possessing sufficient cognitive ability to understand the content and purpose of the study (Mini-Mental State Examination score = 20).
Exclusion criteria
Exclusion criteria: 1) Individuals with contraindications for lower extremity weight-bearing, such as severe joint contracture, osteoporosis, or untreated fractures. 2) Individuals unable to wear the device due to skin conditions or open wounds. 3) Individuals with a significant discrepancy in leg length. 4) Individuals with severe deformities or joint contractures in the lower extremities. 5) Individuals at high risk of fractures due to osteoporosis or other conditions. 6) Individuals unable to maintain a sitting or standing posture independently. 7) Individuals with severe spasticity in the lower extremities (Modified Ashworth Scale (MAS) grade 2 or higher). 8) Individuals with severe cognitive impairment (Mini-Mental State Examination score < 20), delirium, or severe language impairment that prevents cooperation with robotic-assisted orthopedic exercise device gait therapy. 9) Individuals unable to maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or cardiopulmonary insufficiency. 10) Individuals with other conditions affecting gait, such as peripheral neuropathy from alcohol addiction or severe diabetes, or Parkinsonism. 11) Pregnant women or those who may be pregnant. 12) Individuals currently participating in another clinical trial. 13) Individuals at high risk of falls or bleeding due to conditions such as blood coagulation disorders. 14) Individuals shorter than 140 cm or taller than 190 cm, or those weighing more than 80 kg. 15) Individuals with any other clinically significant findings deemed inappropriate for the study by the principal investigator or study staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gait speed of 10m walk test | — |
Secondary
| Measure | Time frame |
|---|---|
| 36-Item Short Form Survey Instrument (SF-36);Beck Depression Inventory (BDI);Body composition analysis results;Spatiotemporal parameters of gait;Timed Up and Go Test (TUGT);Berg Balance Scale (BBS);Satisfaction survey regarding the use of the robotic-assisted orthopedic exercise device based on a 12-item, 5-point scale from K-QUEST | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Ick Choi
Yonsei University
Outcome results
None listed