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

NCT05598463 | Unknown

• 1 other identifier: OASIS Pro_study
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Telerehabilitation; Geriatrics; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (2)

• Satisfaction with Intervention device (OASIS Pro)

  1month

• Usability with Intervention device (OASIS Pro)

  1month

Study Arms (2)

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.

Device: OASIS Pro

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.

Interventions

OASIS Pro DEVICE

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.

Augmented reality and wearable sensor-based home rehabilitation exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Seniors over 65

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korea Medical Device Development Fund grant: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Ji Hye Hwang, Professor

CONTACT

82-10-9933-2816; jhlee.hwang@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: August 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)