Electrically powered wearable device to improve walking and balance in people with gait disorders
Study to Verify the Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Gait Disorders : Investigator-Initiated, Single-Center, Single-Group Clinical Trial
This pilot will try an electrically powered orthopedic exercise device to see if it helps adults with gait or balance problems walk better and more safely.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin-si, Gyeonggi-do, South Korea) |
| Trial ID | NCT07147543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with subjective gait or balance complaints, a Functional Ambulatory Category score below 4, adequate cognition (MMSE ≥ 20), and the ability to sit on the bed edge and stand for 10 seconds are ideal candidates.
Not a fit: Patients with contraindications to lower-extremity weight-bearing (severe contractures, osteoporosis, untreated fractures), skin problems that prevent wearing the device, major limb length discrepancy, severe deformities, or insufficient cognitive ability are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could improve walking speed, endurance, and balance and reduce fall risk, helping patients maintain independence.
How similar studies have performed: Previous small studies of powered wearable orthoses and robotic gait aids have shown promising but variable improvements in gait and balance, so this approach is supported but not yet conclusively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Yongin-si, Gyeonggi-do, South Korea
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.