Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 5:53 AM
Study NCT ID:
NCT07489092
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: