Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge

NCT07489092 | Recruiting

• 1 other identifier: 2026-0021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Acquired Weakness (ICUAW)

Keywords

Intensive Care Unit Acquired weakness; Digital Therapeutics

Outcome Measures

Primary Outcomes (8)

• 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.)

  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

Study Arms (1)

Digital Rehabilitation Group

EXPERIMENTAL

Device: Digital Rehabilitation Group

Interventions

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.

Digital Rehabilitation Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul National University Bundang Hospital: collaborator
• EverEx Inc.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Central Study Contacts

Won Kim, Associate professor

CONTACT

82+02-3010-1694; duocl79@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: March 23, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)