Electrically powered wearable device to improve walking and balance in people with gait disorders

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 single-group, interventional pilot enrolls 30 participants with gait disorders to compare walking and balance performance without and with an electrically powered orthopedic exercise device. Under the prescription and supervision of a rehabilitation medicine specialist, participants complete standardized tests including the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go, and the Berg Balance Scale with rest periods between assessments. Assessments and device use occur in a rehabilitation testing room at Yongin Severance Hospital, and data on gait speed, endurance, balance scores, and adverse events will be recorded. The study is designed to characterize immediate functional changes and device safety in a clinical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 19 years or older
2. Patients experiencing subjective gait or balance disorders
3. Individuals who visited Yongin Severance Hospital, understood the study, voluntarily agreed to participate, and signed the consent form
4. Patients with a Functional Ambulatory Category (FAC) score of less than 4
5. Individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without support
6. Individuals with sufficient cognitive ability to follow and understand simple instructions (Mini-Mental State Examination score ≥ 20)

Exclusion Criteria:

1. Individuals with contraindications to weight-bearing in the lower extremities, such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
2. Individuals who cannot wear the device due to skin diseases or open wounds
3. Individuals with a significant discrepancy in lower extremity length
4. Individuals with severe lower extremity deformities or joint contractures
5. Individuals unable to maintain a sitting or standing posture independently
6. Individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe speech impairment preventing cooperation in wearing the device
7. Individuals unable to stand or walk for extended periods due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
8. Pregnant or potentially pregnant individuals
9. Individuals with other clinically significant conditions deemed inappropriate for this study by the principal investigator or research team based on medical judgment

Where it's running

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