Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders
Trial Parameters
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 affecting gait but also from the decline in physiological and neurological functions associated with the normal aging process. Gait is a fundamental daily activity that requires the coordinated integration of the central and peripheral nervous systems, as well as the musculoskeletal system. Therefore, impairments in any of these systems-including the nervous, cardiovascular, respiratory, or musculoskeletal systems-can lead to gait dysfunction. Gait disorders negatively impact quality of life by increasing the risk of falls, reducing the ability to perform activities of daily living (ADLs), and limiting physical activity. Accordingly, various approaches to maintaining and improving gait function in older adults are being actively explored. Currently, gait aids such as canes and walkers are commonly used to support individuals with gait impairments. These devices help redistribute body weight by providing a broader base of support, thereby assisting with balance and stability. However, they do not directly facilitate the movement of the lower limbs. To enhance gait function, numerous studies have investigated repetitive lower-limb movement training using bicycles or robotic devices. However, the extent of functional improvement resulting from such training remains unclear, and the long-term efficacy is still uncertain. Recent advancements in sensing technology for joint motion and actuator efficiency have led to the development of wearable assistive devices that are significantly more compact and lightweight compared to conventional robotic systems. This study aims to evaluate the effectiveness of a newly developed electrically powered orthopedic exercise device in patients with gait disorders by assessing changes in gait parameters upon wearing the device, thereby exploring its clinical feasibility.
Eligibility 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