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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| EverEx Inc. | INDUSTRY |
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This study aims to evaluate the feasibility, usability, and clinical effectiveness of a digital rehabilitation platform in adult patients discharged from the intensive care unit (ICU). Adult patients aged 19 years or older who stayed in the ICU for more than 48 hours and are capable of using a smartphone will be enrolled from two tertiary hospitals in South Korea.
Participants will receive individualized rehabilitation programs using a digital rehabilitation platform ("Tuntun Rehabilitation Assistant") based on their functional status. Rehabilitation will be conducted once daily for up to 30 minutes per session. Physical and cognitive function outcomes will be assessed at baseline, two weeks after intervention initiation, at hospital discharge, and during follow-up when applicable.
This prospective cohort study will investigate changes in physical function, mobility, cognitive status, and quality of life, as well as platform usage and safety-related events, to determine the clinical usefulness of digital rehabilitation for ICU survivors.
This is a prospective cohort clinical study designed to evaluate the feasibility, usability, and clinical effectiveness of a digital rehabilitation platform in adult patients discharged from the intensive care unit (ICU).
Study Population Eligible participants are adult patients aged 19 years or older who were admitted to the ICU for more than 48 hours at Seoul Asan Medical Center or Seoul National University Bundang Hospital. Participants must own a smartphone, be capable of operating a digital platform, and provide voluntary informed consent.
Study Design and Sample Size This is a multicenter prospective cohort study. Approximately 40 participants will be recruited from Seoul Asan Medical Center and 30 participants from Seoul National University Bundang Hospital.
Intervention Participants will receive individualized rehabilitation interventions using the digital rehabilitation platform "Tuntun Rehabilitation Assistant." At enrollment, overall physical function will be assessed, and an appropriate rehabilitation program will be prescribed accordingly. The intervention will be administered once daily, with each session lasting no more than 30 minutes.
During the first five sessions, a researcher will visit the patient's hospital room to assist with the intervention. Afterward, participants will continue the rehabilitation independently using the digital platform.
Outcome Assessments Assessments will be conducted at baseline, two weeks after intervention initiation, and at hospital discharge. For participants who remain hospitalized for more than four weeks after the two-week assessment, an additional evaluation will be performed four weeks after the two-week assessment.
Participants discharged after completing in-hospital assessments will continue using the digital rehabilitation platform at home until their outpatient follow-up visit one month after discharge, at which time an additional evaluation will be conducted.
Data Collection Patient characteristics, outcome measures, and intervention-related data will be collected, including physical function, mobility, cognitive status, quality of life, platform usage, adherence, and safety-related events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Rehabilitation Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Rehabilitation Group | Device | The Tuntun Rehabilitation Assistant is a smartphone-based digital rehabilitation platform designed for patients discharged from the intensive care unit. Rehabilitation sessions are conducted once daily, with each session lasting up to 30 minutes. During the initial five sessions, a researcher assists participants in performing the intervention in the hospital room. Thereafter, participants independently perform the prescribed exercises using the digital platform. The intervention is continued during hospitalization and, when applicable, after discharge until outpatient follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Research Council Sum Score (MRC-SS) | Summation score of muscle strength based on MRC scale. Unit of Measure: Sum score (0 to 60, where a higher score indicates better overall muscle strength.) | From enrollment to the end of treatment at 2 weeks |
| Functional Ambulatory Category (FAC) | Measurement of the level of ambulation and assistance required. Unit of Measure: FAC score (0 to 5, where a higher score indicates greater walking independence.) | From enrollment to the end of treatment at 2 weeks |
| Mini-Mental State Examination (MMSE) | Cognitive function assessment using the MMSE tool. Unit of Measure: MMSE score (0 to 30, where a higher score indicates better cognitive function.) | From enrollment to the end of treatment at 2 weeks |
| EQ-5D-5L | Assessment of patient-reported quality of life using the EQ-5D-5L questionnaire, which includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale. Responses were converted to a utility index score. Unit of Measure: Utility score (0 to 1). | From enrollment to the end of treatment at 2 weeks |
| EQ-5D VAS | Assessment of patient-reported quality of life using the EQ-5D visual analog scale (VAS), where participants rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). Unit of Measure: VAS score (0 to 100). | From enrollment to the end of treatment at 2 weeks |
| SLR time | Assessment of straight leg raise (SLR) repetitions over 60 seconds and static holding ability. Unit of Measure: time (seconds) (For time: A higher value indicates better static endurance.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Kim, Associate professor | Contact | 82+02-3010-1694 | duocl79@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
All individual patient data (IPD) used in this study will be handled in compliance with domestic privacy protection laws and relevant regulations. The privacy of study participants will be strictly safeguarded, and their personal information will not be used for purposes other than the study. When sharing data, only de-identified data that has been approved by the researchers after adequate request will be provided, and privacy protection and security will be prioritized throughout the process.
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| From enrollment to the end of treatment at 2 weeks |
| SLR count | Assessment of straight leg raise (SLR) repetitions performed within 60 seconds. Unit of Measure: Count (repetitions) (For count: A higher value indicates better performance.) | From enrollment to the end of treatment at 2 weeks |
| Short Physical Performance Battery (SPPB) Total Score | Assessment of lower extremity physical performance using the Short Physical Performance Battery (SPPB), which includes balance tests, gait speed, and repeated chair stand tests. Scores range from 0 to 12, with higher scores indicating better physical performance. Unit of Measure: Total score (0 to 12). | From enrollment to the end of treatment at 2 weeks |