Home-based hip-assisted robot gait training for stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two groups over 6 weeks: one uses a hip-assisted wearable robot with feedback as part of a home exercise program, and the other performs the same exercises without the robot. The wearable system includes a shoe sensor, a wrist activity tracker, and a mobile app that provides feedback and collects user input. Participants undergo initial assessments, then 4 sessions of robot-assisted gait training at home or near-home spaces, each lasting 30 minutes, with visits spaced up to 5 days apart. End-of-study assessments mirror the initial tests, and user satisfaction with the device is measured. The goal is to determine whether the wearable feedback improves physical function, cognitive outcomes, and daily activity, while also evaluating usability and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Yongin Severance Hospital
  Yongin-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Na Young Kim, MD, PhD — Severance Hospital
• Study coordinator: Na Young Kim, MD, PhD
• Email: kny8452@yuhs.ac
• Phone: +82 010 9127 4482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.