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

Not Applicable

Recruiting

• Conditions: Gait Disorders

• Registration Number: NCT07147543
• Lead Sponsor: Yonsei University

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.

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 measuring and analyzing gait function and balance ability in patients with gait disorders under both non-wearing and wearing conditions.

(2) Experimental Group and Evaluation Procedures

1. Participant Selection:

This study includes a single test group with a total of 30 participants. The selection of participants for the electrically powered orthopedic exercise device and the overall study process will be conducted under the prescription and guidance of a rehabilitation medicine specialist, and supervised by assistants (physicians and occupational therapists). The examiner will collect clinical information and conduct a screening assessment for each participant.

2. Evaluation Phase Without Device:

After the screening test, participants undergo assessments of walking ability and balance without wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist).

3. Pre-Adaptation Phase:

After the evaluations without the device, a total of four adaptation sessions are conducted, during which the participant wears the device and performs short-distance walking within 10 meters. These sessions are designed to help the participant become familiar with the operation and wearing method of the H10 device. Appropriate device settings are configured for each participant to minimize any potential inexperience or anxiety during use. Participants must complete all four adaptation sessions, and each session should be conducted within a two-week interval.

4. Evaluation Phase:

After completing all four adaptation sessions, participants undergo assessments of walking ability and balance while wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist). After the evaluations are completed, a usability and satisfaction survey regarding the motorized orthopedic exercise device is conducted.

Study Timeline

• Study Start: 2025-04-07
• Study First Submitted: 2025-04-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-04-06
• Study Completion: 2026-04-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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
5. Individuals unable to maintain a sitting or standing posture independently
6. Individuals with severe cognitive impairment (Mini-Mental State Examination score < 20), delirium, or severe speech impairment preventing cooperation in wearing the device
7. Individuals unable to stand or walk for extended periods due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
8. Pregnant or potentially pregnant individuals
9. Individuals with other clinically significant conditions deemed inappropriate for this study by the principal investigator or research team based on medical judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
10-Meter 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	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.

Secondary Outcome Measures

Name	Time	Method
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	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
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	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.
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	While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.; Cadence: The number of steps taken per minute, measured in steps per minute (spm).
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	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.
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	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.
Spatiotemporal Parameters of Gait : Stride Length	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	While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.; Stride Length: The distance between the heel of one foot to the heel of the same foot during consecutive steps. Measured in meters (m), stride length is adjusted for height to account for differences in body size.
Spatiotemporal Parameters of Gait : Self-Selected Walking Speed	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	While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.; Self-Selected Walking Speed: The participant's walking speed when walking naturally at a comfortable pace.
Spatiotemporal Parameters of Gait : Distance	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	While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.; Distance: The total distance covered during walking, measured in meters (m).
Satisfaction evaluation	Upon completion of the end-point assessment conducted on the same day as session 4	Participants will complete a satisfaction survey for usability and satisfaction assessment of the electrically powered orthopedic exercise device, based on the Korean version of the Quebec User Evaluation of Satisfaction with assistive Technology (K-QUEST 2.0).21 This survey consists of 12 items on a 5-point scale. Participants rate their satisfaction with the assistive device and related services.; (An average score of 4 or higher will be interpreted as positive satisfaction, an average score of 2 or lower will be interpreted as negative satisfaction)

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin-si, Gyeonggi-do, South Korea, South Korea