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临床试验/NCT05598463
NCT05598463招募中不适用

The Effect of AR-based Home Rehabilitation Exercise Combined With Wearable Sensor (IMU) on Physical Function, Depression, Physical Activity, and Self-efficacy in the Elderly: A Exploratory Study on the Effectiveness of OASIS Pro

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
Change of Short Physical Performance Battery (SPPB)

研究概览

简要总结

According to the results of a systematic literature review and meta-analysis based on recent studies on exercise interventions for the elderly based on augmented reality, virtual reality, and functional games, these technology-based exercise interventions It was confirmed that there was a positive effect on the function. In addition, it was found to indirectly enhance the motivation for performing physical exercise. In a recent similar study, when an exercise program was applied to 27 elderly people for 3 months through an exercise device that can measure body movements in real time through a Kinect camera, the physical activity of the elderly was induced, and the sustainability of exercise was increased. It is expected that this will be effective in preventing muscle loss in the elderly.

However, due to the limitations of the existing Kinect camera, motions that have to be performed lying down or when exercising while wearing black clothes overlapped the movements of the lower extremities and caused motions in which the joint position could not be accurately tracked, thereby reducing the accuracy of exercise performance. There were limitations that could not be measured. In order to solve these technical limitations and improve clinical applicability, several existing studies have conducted inertia measurement that can accurately detect the motion of lower extremity joints by measuring the speed, acceleration, and direction of body movement in the X, Y, and Z axes. I started using Inertial Measurement Units (IMUs). Wearable sensors such as IMUs can enhance motor learning by providing immediate feedback on motor performance and motor errors. In addition, in the case of commercial camera systems such as the Kinect camera, if the user's appearance is obscured by other objects, there is a disadvantage that it is not detected. This is an important advantage in a home environment where there is no medical supervision, and this risk can be minimized, especially for the elderly who are at risk of falling. Previously, several literatures have applied the IMU sensor to the elderly and patients with total knee/hip arthroplasty and confirmed the effect.

In this study, the OASIS Pro to be used can receive visual feedback by applying a virtual environment (number of exercises, exercise target point, and holding time) with the real home environment as the background. The Kinect camera can be used alone, and at the same time, an IMU sensor can be attached to the lower extremities to perform precise movements. The user performs the exercise prescribed by the manager (medical staff), and when the exercise is finished, the user can receive feedback on the accuracy and performance. Administrators can create and manage individual exercise protocols through OASIS-Manager. Therefore, the investigators intend to prove the effectiveness of OASIS Pro by applying augmented reality-based home rehabilitation exercise combined with IMU sensor to the elderly and confirming the effect on physical ability, depression, physical activity, and self-efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Seniors over 65

排除标准

  • •Persons with severe comorbidities that make exercise impossible due to unstable angina, acute myocarditis, aneurysm, uncontrolled cardiovascular disorder, etc.
  • •Those with neurological and visual impairments to the extent that movement is difficult
  • •Those with dizziness during exercise
  • •Those who participate in a regular exercise program more than twice a week or are receiving physical therapy
  • •Those who have difficulty in communicating and maintaining necessary education and maintenance in the research process
  • •Others who should not perform exercise as judged by a medical professional

研究组 & 干预措施

Augmented reality and wearable sensor-based home rehabilitation exercise

Experimental

Experimental group performs augmented reality and wearable sensor-based home rehabilitation exercise for 4 weeks. And then, their exercise compliance is monitored by medical staff.

干预措施: OASIS Pro (Device)

Control group

No Intervention

Control group is asked to maintain their own physical activity amount, not involve the regular exercise program additionally for 4 weeks after enrollment.

结局指标

主要结局

Change of Short Physical Performance Battery (SPPB)

时间窗: Enrollment, 1month

comparison between groups in change of SPPB score between baseline (enrollment) and after 1 months. This max score is 12 (range from zero to 12), meaning higher score, and higher physical performance.

次要结局

  • Change of Exercise Self-efficacy(Enrollment, 1month, 2 month)
  • Change of depression (using Short form of Geriatric depression scale, SGDS-K)(Enrollment, 1month, 2 month)
  • Change of physical activity (using Korean Version of Physical Activity Scale for the Elderly, K-PASE)(Enrollment, 1month, 2 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JiHye Hwang

Professor

Samsung Medical Center

研究点 (1)

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