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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 10-Meter Walk Test
研究概览
简要总结
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.
详细描述
(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
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
干预措施: Electrically Powered Orthopedic Exercise Device (Device)
结局指标
主要结局
10-Meter Walk Test
时间窗: 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.
次要结局
- 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)
- 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)
- 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 : 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)
- 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)
- 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)
- Satisfaction evaluation(Upon completion of the end-point assessment conducted on the same day as session 4)