Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders

NCT07147543 | Recruiting Phase 4

• 1 other identifier: 9-2025-0021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Disorders

Keywords

Rehabilitation; Gait; Wearable robot; Gait Disorders

Outcome Measures

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.

  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 4

Secondary Outcomes (9)

• Timed Up and Go (TUG) Test

  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 4

• 6-Minute Walk Test

  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 4

• Berg balance scale (BBS)

  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 4

• Spatiotemporal Parameters of Gait : Total Step Count

  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 4

• Spatiotemporal Parameters of Gait : Cadence

  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 4

Study Arms (1)

Wearing conditions of Electrically Powered Orthopedic Exercise Device

EXPERIMENTAL

Participants will undergo gait and balance function tests under both non-wearing and wearing conditions of the electrically powered orthopedic exercise device

Device: Electrically Powered Orthopedic Exercise Device

Interventions

Electrically Powered Orthopedic Exercise Device DEVICE

Participants 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.

Wearing conditions of Electrically Powered Orthopedic Exercise Device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea, 16995, South Korea

RECRUITING

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MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Na Young Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Hwi Woo Yang

CONTACT

+82 010 7360 4439; Rehab5@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Researchers will compare non-wearing and wearing conditions of the electrically powered orthopedic exercise device walking speeds, spatiotemporal parameters, balance, and satisfaction survey in participants and does not establish a control group.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: August 29, 2025
• Study Start: April 7, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)