Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders
ConditionGait Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Electrically Powered Orthopedic Exercise Device
DeviceParticipants who pass the screening undergo an evaluation of gait function and balance ability without wearing the Electrically Powered Orthopedic Exercise Device. Afterward, the patient wears the motorized orthopedic exercise device for a total of four adaptation sessions. In each session, the patient performs short-distance walking within 10 meters while wearing the device to explore the appropriate assistive mode and level of support that match their physical condition. No evaluations are conducted while wearing the device during sessions 1, 2, and 3. After the 4th session, an evaluation identical to the one conducted without the device is performed while wearing it, and a satisfaction survey is conducted.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Wearing conditions of Electrically Powered Orthopedic Exercise DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
10-Meter Walk Test
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.
Time frame
A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4Secondary outcomes
1
Timed Up and Go (TUG) Test
Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back. The average time of three trials was recorded as a result
Time frame
A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 42
6-Minute Walk Test
Patients are instructed to walk back and forth along the 30-meter path as many times as possible within 6 minutes. The examiner records the total distance covered, abnormal gait patterns, and the time of occurrence of any gait deviations.
Time frame
A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 43
Berg balance scale (BBS)
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
Time frame
A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 44
Spatiotemporal Parameters of Gait : Total Step Count
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Total Step Count: The total number of steps taken during walking.
Time frame
A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4Sponsors and contacts
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Source ClinicalTrials.gov