Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge

March 19, 2026 updated by: Won Kim, Asan Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Won Kim, Associate professor
  • Phone Number: 82+02-3010-1694
  • Email: duocl79@gmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 19 years or older.
  • Admission to the intensive care unit (ICU) for more than 48 hours.
  • Hospitalization at Asan Medical Center or Seoul National University Bundang Hospital.
  • Discharge from the ICU at the time of enrollment.
  • Ownership of a smartphone and ability to operate a digital rehabilitation platform.
  • Ability to understand the study procedures and provide voluntary written informed consent.

Exclusion Criteria:

  • Medical conditions that contraindicate participation in rehabilitation exercise, as determined by the attending physician.
  • Severe cognitive impairment or communication difficulties that interfere with understanding or following study instructions.
  • Unstable medical conditions requiring ongoing intensive medical treatment.
  • Inability to use a smartphone or digital platform independently.
  • Refusal to participate or withdrawal of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Rehabilitation Group
Device: Digital Rehabilitation Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Research Council Sum Score (MRC-SS)
Time Frame: From enrollment to the end of treatment at 2 weeks
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)
Time Frame: From enrollment to the end of treatment at 2 weeks
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)
Time Frame: From enrollment to the end of treatment at 2 weeks
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
Time Frame: From enrollment to the end of treatment at 2 weeks
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
Time Frame: From enrollment to the end of treatment at 2 weeks
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
Time Frame: From enrollment to the end of treatment at 2 weeks

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.)
From enrollment to the end of treatment at 2 weeks
SLR count
Time Frame: From enrollment to the end of treatment at 2 weeks
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
Time Frame: From enrollment to the end of treatment at 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Seoul National University Bundang Hospital
EverEx Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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