Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Medical Research Council Sum Score (MRC-SS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medical Research Council Sum Score (MRC-SS)
时间窗: 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.)
Functional Ambulatory Category (FAC)
时间窗: 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.)
Mini-Mental State Examination (MMSE)
时间窗: 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.)
EQ-5D-5L
时间窗: 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).
EQ-5D VAS
时间窗: 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).
SLR time
时间窗: 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.)
SLR count
时间窗: 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.)
Short Physical Performance Battery (SPPB) Total Score
时间窗: 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).
次要结局
未报告次要终点
研究者
Won Kim
Associate Professor
Asan Medical Center