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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Republic of Korea
Yongin Severance Hospital
RECRUITING
Yongin-si
Contact Information
Primary
Na Young Kim, MD, PhD
kny8452@yuhs.ac
+82 010 9127 4482
Backup
Hwi Woo Yang
Rehab5@yuhs.ac
+82 010 7360 4439
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2026-04-06
Participants
Target number of participants: 30
Treatments
Experimental: Wearing conditions of Electrically Powered Orthopedic Exercise Device
Participants will undergo gait and balance function tests under both non-wearing and wearing conditions of the electrically powered orthopedic exercise device
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov