Status:
RECRUITING
Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders
Lead Sponsor:
Yonsei University
Conditions:
Gait Disorders
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Aging is a global trend, and consequently, the prevalence of age-related diseases is increasing. Gait disorders are common among the elderly and can result not only from various underlying conditions ...
Detailed Description
(1) Overview of study design This investigator-initiated exploratory study is a pilot study designed to evaluate the effectiveness and safety of the Electrically Powered Orthopedic Exercise Device by ...
Eligibility Criteria
Inclusion
- Adults aged 19 years or older
- Patients experiencing subjective gait or balance disorders
- Individuals who visited Yongin Severance Hospital, understood the study, voluntarily agreed to participate, and signed the consent form
- Patients with a Functional Ambulatory Category (FAC) score of less than 4
- Individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without support
- Individuals with sufficient cognitive ability to follow and understand simple instructions (Mini-Mental State Examination score ≥ 20)
Exclusion
- Individuals with contraindications to weight-bearing in the lower extremities, such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
- Individuals who cannot wear the device due to skin diseases or open wounds
- Individuals with a significant discrepancy in lower extremity length
- Individuals with severe lower extremity deformities or joint contractures
- Individuals unable to maintain a sitting or standing posture independently
- Individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe speech impairment preventing cooperation in wearing the device
- Individuals unable to stand or walk for extended periods due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
- Pregnant or potentially pregnant individuals
- Individuals with other clinically significant conditions deemed inappropriate for this study by the principal investigator or research team based on medical judgment
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 6 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07147543
Start Date
April 7 2025
End Date
April 6 2026
Last Update
August 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, South Korea, 16995