The Exploratory Study of AR-based Home Rehabilitation Exercise Combined With Wearable Sensor (IMU) in the Elderly

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598463
• Other study ID #: OASIS Pro_study
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Samsung Medical Center
• Contact: Ji Hye Hwang, Professor
• Phone: 82-10-9933-2816
• Email: jhlee.hwang[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Seniors over 65

Exclusion Criteria:

1. Persons with severe comorbidities that make exercise impossible due to unstable angina, acute myocarditis, aneurysm, uncontrolled cardiovascular disorder, etc.

2. Those with neurological and visual impairments to the extent that movement is difficult

3. Those with dizziness during exercise

4. Those who participate in a regular exercise program more than twice a week or are receiving physical therapy

5. Those who have difficulty in communicating and maintaining necessary education and maintenance in the research process

6. Others who should not perform exercise as judged by a medical professional

Related Conditions & MeSH terms

• Exercise
• Geriatrics
• Telerehabilitation

Intervention

Device:
• OASIS Pro
This device can track the joint movement and provide real-time feedback on the exercise performance and accuracy using Kinect camera sensor, and Wearable sensor (IMU). This device is connected to the website, which available for medical staff prescribe the exercise protocol and monitor individual exercise adherence.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korea Medical Device Development Fund grant

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with Intervention device (OASIS Pro)	It consists of multiple-choice questions about overall satisfaction with OASIS Pro and usefulness, and subjective-type questions about satisfaction and improvements.; minimum and maximum values have 0 and 5 points respectively. Higher scores mean better outcome.	1month
Other	Usability with Intervention device (OASIS Pro)	It is evaluated by System Usability Scale (SUS), comprises of the 10 items. Higher score represents the higher usability.	1month
Primary	Change of Short Physical Performance Battery (SPPB)	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.	Enrollment, 1month
Secondary	Change of Exercise Self-efficacy	This consists of 9 items, and scale ranges from zero (not sure at all) to 10 (very sure), representing the higher score, and higher exercise self-efficacy.	Enrollment, 1month, 2 month
Secondary	Change of depression (using Short form of Geriatric depression scale, SGDS-K)	A total of 15 questions, marked with yes or no. It is a scale of 15 points, and the higher the score, the higher the depression.	Enrollment, 1month, 2 month
Secondary	Change of physical activity (using Korean Version of Physical Activity Scale for the Elderly, K-PASE)	The possible score range is from 0 to 360, with higher scores indicating more physical activity.	Enrollment, 1month, 2 month