TelerehabilitationNCT05598463
The Exploratory Study of AR-based Home Rehabilitation Exercise Combined With Wearable Sensor (IMU) in the Elderly
A study testing OASIS Pro in people with Telerehabilitation and Geriatrics, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Telerehabilitation, Geriatrics, Exercise
- What is being tested?
- OASIS Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Seniors over 65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
JIHYE HWANG, Professor
JIHYE HWANG, Professor
About this study
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
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
- Being tested
- OASIS Pro
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OASIS ProDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment, 1month
Secondary outcomes (3)
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.
Measured: Enrollment, 1month, 2 month
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.
Measured: Enrollment, 1month, 2 month
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.
Measured: Enrollment, 1month, 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start23 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Medical Device Development Fund
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598463
- Sponsor's protocol ID
- OASIS Pro_study
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05598463
- Acronym / sponsor ID
- OASIS Pro_study
- Conditions
- Telerehabilitation, Geriatrics, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korea Medical Device Development Fund
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality and wearable sensor-based home rehabilitation exercise | Experimental | Device: OASIS ProExperimental group performs augmented reality and wearable sensor-based home rehabilitation exercise for 4 weeks. And then, their exercise compliance is monitored by medical staff. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Seniors over 65
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OASIS ProThis 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. | Device | Augmented reality and wearable sensor-based home rehabilitation exercise |
Primary outcome
Change of Short Physical Performance Battery (SPPB)
Time frame: 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.
3 secondary outcomes
Change of Exercise Self-efficacy
Time frame: Enrollment, 1month, 2 month
Change of depression (using Short form of Geriatric depression scale, SGDS-K)
Time frame: Enrollment, 1month, 2 month
Change of physical activity (using Korean Version of Physical Activity Scale for the Elderly, K-PASE)
Time frame: Enrollment, 1month, 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OASIS Pro in people with Telerehabilitation and Geriatrics, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Hye Hwang, Professor (82-10-9933-2816, jhlee.hwang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Short Physical Performance Battery (SPPB) (time frame: Enrollment, 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.