Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 du

Первичные конечные точки

• Medical Research Council Sum Score (MRC-SS) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Functional Ambulatory Category (FAC) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Mini-Mental State Examination (MMSE) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• EQ-5D-5L [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• EQ-5D VAS [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• SLR time [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• SLR count [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Short Physical Performance Battery (SPPB) Total Score [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Идентификаторы

NCT: NCT07489092 · 2026-0021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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