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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Research Council Sum Score (MRC-SS)', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': '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.)'}, {'measure': 'Functional Ambulatory Category (FAC)', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': '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.)'}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Cognitive function assessment using the MMSE tool. Unit of Measure: MMSE score (0 to 30, where a higher score indicates better cognitive function.)'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': '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).'}, {'measure': 'EQ-5D VAS', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': '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).'}, {'measure': 'SLR time', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Assessment of straight leg raise (SLR) repetitions over 60 seconds and static holding ability.\n\nUnit of Measure: time (seconds) (For time: A higher value indicates better static endurance.)'}, {'measure': 'SLR count', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Assessment of straight leg raise (SLR) repetitions performed within 60 seconds. Unit of Measure: Count (repetitions) (For count: A higher value indicates better performance.)'}, {'measure': 'Short Physical Performance Battery (SPPB) Total Score', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Unit Acquired weakness', 'Digital Therapeutics'], 'conditions': ['ICU Acquired Weakness (ICUAW)']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.\n\nThis 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.', 'detailedDescription': '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).\n\nStudy 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.\n\nStudy 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.\n\nIntervention 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.\n\nDuring 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.\n\nOutcome 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.\n\nParticipants 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 years or older.\n* Admission to the intensive care unit (ICU) for more than 48 hours.\n* Hospitalization at Asan Medical Center or Seoul National University Bundang Hospital.\n* Discharge from the ICU at the time of enrollment.\n* Ownership of a smartphone and ability to operate a digital rehabilitation platform.\n* Ability to understand the study procedures and provide voluntary written informed consent.\n\nExclusion Criteria:\n\n* Medical conditions that contraindicate participation in rehabilitation exercise, as determined by the attending physician.\n* Severe cognitive impairment or communication difficulties that interfere with understanding or following study instructions.\n* Unstable medical conditions requiring ongoing intensive medical treatment.\n* Inability to use a smartphone or digital platform independently.\n* Refusal to participate or withdrawal of informed consent.'}, 'identificationModule': {'nctId': 'NCT07489092', 'briefTitle': 'Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge', 'orgStudyIdInfo': {'id': '2026-0021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Rehabilitation Group', 'interventionNames': ['Device: Digital Rehabilitation Group']}], 'interventions': [{'name': 'Digital Rehabilitation Group', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Digital Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Kim', 'role': 'CONTACT', 'email': 'duocl79@gmail.com', 'phone': '+82-02-3010-1694'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Won Kim, Associate professor', 'role': 'CONTACT', 'email': 'duocl79@gmail.com', 'phone': '82+02-3010-1694'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'EverEx Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Won Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}