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

Официальное название

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

Обзор

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.

Подробное описание

(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.

Вмешательства

• Устройство Electrically Powered Orthopedic Exercise 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 con

Первичные конечные точки

• 10-Meter Walk Test [Срок оценки: 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]

Вторичные конечные точки (9)

• Timed Up and Go (TUG) Test [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Upon completion of the end-point assessment conducted on the same day as session 4]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Yongin Severance Hospital — Yongin-si

Публикации

• Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x. PMID 16696738
• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. PMID 1991946
• Lee, Sang-Heon, Bong-Keun Jung, and So-Yeon Park. "Korean Translation and Psychometric Properties of Quebec User Evaluation of Satisfaction Assistive Technology 2.0." Journal of the Korea Academia-Industrial Cooperation Society. The Korea Academia-Industrial Cooperation Society, July 31, 2013.
• Bang DH, Shin WS. Effects of robot-assisted gait training on spatiotemporal gait parameters and balance in patients with chronic stroke: A randomized controlled pilot trial. NeuroRehabilitation. 2016 Apr 6;38(4):343-9. doi: 10.3233/NRE-161325. PMID 27061162
• Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27. PMID 23023812
• Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23. PMID 3978515
• Dolny DG, Collins MG, Wilson T, Germann ML, Davis HP. Validity of lower extremity strength and power utilizing a new closed chain dynamometer. Med Sci Sports Exerc. 2001 Jan;33(1):171-5. doi: 10.1097/00005768-200101000-00026. PMID 11194105
• Kim Heon-tae, Moon Jun-bae, Ryu Seung-ho, and Kang Min-soo. Validity study of the Korean version of the International Physical Activity Questionnaire (IPAQ): Verification of construct-related validity. Korean Journal of Physical Education No. 2017;56

Идентификаторы

NCT: NCT07147543 · 9-2025-0021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗