Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients

After obtaining written consent, a screening test is performed. In the screening test, after taking a history of the subject's baseline symptoms and signs, the past history and medication history are confirmed, vital signs are measured, and a physical examination is conducted, and the overall gait status such as whether assistive devices are used during gait and the gait pattern is assessed. Subjects who pass the screening test undergo the initial assessment within 7 days.

The initial assessment is conducted including the 2-Minute Walk Test, spatiotemporal gait parameters, the Berg Balance Scale, and subjects who complete the initial assessment begin robot-assisted gait training on the same day.

After the initial assessment, gait training using the hip-assisted wearable robot is performed in the home or an indoor space near the home twice a week for 2 weeks, a total of 4 times, for 30 minutes each. The interval between each intervention visit is set not to exceed 5 days.

After the end of the 2 weeks of robot-assisted gait training, on the day of completion, the end-of-study assessment is performed identically to the initial assessment, and a satisfaction assessment for the hip-assisted wearable robot is conducted.

In addition, when a device abnormality occurs, measures are taken and the relevant details are recorded, the usability of the hip-assisted wearable robot is analyzed, the gait and balance function assessment results in the non-wearing/wearing states of the hip-assisted wearable robot are statistically compared before and after gait training, and the burden and satisfaction assessments of the hip-assisted wearable robot are analyzed.

Inclusion criteria

• Adults aged 19 years or older and under 80 years
• Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography
• Persons for whom at least 1 month has elapsed since the diagnosis of stroke
• Persons showing a spastic hemiplegic gait pattern due to stroke
• Patients with a Functional Ambulatory Category score below 4
• Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance
• 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

• Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture
• Persons for whom wearing the device is difficult due to skin disease or open wounds
• Persons with a severe difference in the length of the two lower extremities
• Persons with severe deformity or joint contracture in the lower extremities
• Persons unable to maintain a sitting posture or a standing posture on their own
• Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)
• 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
• Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
• Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes
• Pregnant women or patients with the possibility of pregnancy
• Persons currently participating in another clinical trial
• Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like
• Persons with a height less than 140 cm or greater than 190 cm
• Persons for whom wearing the robot is not possible
• 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