Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
ConditionICU Acquired Weakness (ICUAW)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Digital Rehabilitation Group
DeviceThe 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Digital Rehabilitation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.)
Time frame
From enrollment to the end of treatment at 2 weeks2
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.)
Time frame
From enrollment to the end of treatment at 2 weeks3
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.)
Time frame
From enrollment to the end of treatment at 2 weeks4
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).
Time frame
From enrollment to the end of treatment at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Asan Medical Center
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
EverEx Inc.
Collaborator
Source ClinicalTrials.gov