Research on Evaluation of Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 6-minute walking test results
研究概览
简要总结
The goal of this clinical trial is to evaluate whether monitoring and providing feedback on the performance of a home-based exercise program using an integrated wearable monitoring system improves physical and cognitive function, and activity level in participants with stroke.
The integrated wearable monitoring system consists of an insole-type gait analyzer for objective gait assessment, a wrist-worn activity tracker for monitoring daily physical activity, and a self-report mobile application for delivering feedback and collecting participant-reported information.
This study also aims to assess participant satisfaction with the integrated wearable monitoring system during a 6-week home-based gait rehabilitation program.
The main questions this study aims to answer are:
- What effect does monitoring and providing feedback using an integrated wearable monitoring system have on physical and cognitive function, and activity level during a home-based gait rehabilitation program?
- How satisfied are participants with the use of the integrated wearable monitoring system?
Researchers will compare an intervention group that receives the integrated wearable monitoring system with a control group that performs the same home-based exercise program without wearable monitoring and feedback.
Participants in the intervention group will receive an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application, along with training in a prescribed home-based exercise program. During the 6-week intervention period, participants will wear the insole-type gait analyzer and the activity tracker while performing the home-based exercise program and will use the mobile application to receive feedback and self-report selected daily health-related information. After completion of the 6-week program, the investigators will conduct a satisfaction survey to evaluate participant experience with the integrated wearable monitoring system.
详细描述
After obtaining written informed consent, a screening assessment is conducted to determine participant eligibility.
The screening assessment evaluates whether participants, regardless of assistive device use, are able to walk independently for more than 10 meters, based on an assessment of baseline symptoms and clinical signs. Eligible participants who pass the screening assessment are randomly assigned to either an intervention group or a control group.
Both groups undergo an initial assessment, during which baseline gait-related outcomes are measured. Participants are provided with information regarding their current gait status and general characteristics of normal gait and are instructed in a standardized home-based exercise program.
Participants assigned to the intervention group are provided with an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application. The researcher provides training on the proper use of the wearable devices and application and instructs participants to wear the devices as frequently and for as long as possible during daily activities and exercise sessions to enable continuous recording of gait patterns and physical activity. Based on the collected wearable data, the researcher provides individualized feedback to participants in the intervention group via telephone on a weekly basis.
Participants in the control group perform the same home-based exercise program but do not receive wearable monitoring devices or feedback related to their exercise performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Anonymization is achieved by using the unique number of the wearable devices issued to the subject, and data collected through the application will be stored in accordance with the medical device company's security policy and will be discarded after the end of the study, and will be deidentified before being forwarded to the medical device company. De-anonymization is limited to cases where it is necessary in relation to the individual's treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 years of age
- •Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory
- •Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form
排除标准
- •Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
- •Progressive or unstable brain disease
- •In addition to above, those who have clinically significant findings that are deemed inappropriate for this study in the medical judgment of the study director or person in charge
研究组 & 干预措施
Multi-modal Wearable Devices and Self-report Application group receiving monitoring and feedback
The intervention group uses an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application, and participants are instructed to use the wearable devices as frequently and for as long as possible during daily activities, particularly during outdoor walking. Researchers provide individualized feedback to participants once a week based on data collected from the wearable devices and the mobile application. After 6 weeks, usability and satisfaction with the integrated wearable monitoring system are evaluated.
干预措施: Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program (Device)
Control group
The control group is trained in the same exercise program as the intervention group, but doesn't use an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application.
结局指标
主要结局
6-minute walking test results
时间窗: This test results will be assessed two times: baseline, exit (after 6 weeks)
While wearing the insole gait analyzer, the subject performs a 6-minute gait test, which is the test that most closely approximates everyday walking, and the examiner provides feedback on the gait by comparing the average parameter data extracted from the insole gait analyzer to a normal gait reference. The above evaluation is a test conducted to evaluate walking endurance, and the evaluation method is as follows. 1. Install a colored cone with 30m on the floor and prepare a stopwatch. 2. Instruct the subject to travel as many times as possible in a straight line of 30m for 6 minutes. 3. Teach that they can rest and stop during the test and use only permitted phrases ('You're doing well', 'Keep going'). 4. The examiner records the total distance traveled and the pattern and occurrence time of the abnormal gait.
次要结局
- Korean version of Sarcopenia Screening Questionnaire(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Functional Ambulation Category(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Mini-Nutritional Assessment(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Korea-Mini Mental State Examination(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Grip Strength Test(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Timed up and go test (TUG)(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Berg Balance Scale(This test results will be assessed two times: baseline, exit (after 6 weeks))
- body composition analysis(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Cybex isokinetic strength evaluation(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Spatiotemporal parameters of walking(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Clinical Frailty Scale(This test results will be assessed two times: baseline, exit (after 6 weeks))
- European Quality of Life-5 Dimensions(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Korean version of the International Physical Activity Questionnaire (K-IPAQ)(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Short Physical Performance Battery (SPPB)(This test results will be assessed two times: baseline, exit (after 6 weeks))
- Application survey response rate(This test results will be assessed up to 6 weeks)
- K-QEUST-based wearable device satisfaction assessment(This test result will be assessed once at the end of the 6-week intervention.)
- 10m Walk Test(This test results will be assessed two times: baseline, exit (after 6 weeks))