Feasibility of Exergame-Based Rehabilitation in Patients With Limited Mobility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Session Completion Rate
研究概览
简要总结
- Study Title:
Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study 2. Purpose of the Study:
This study aims to evaluate the feasibility and safety of an exergame-based rehabilitation program using motion recognition for bedridden inpatients. The primary objective is to determine whether digital rehabilitation can serve as a substantial adjunct to augment total rehabilitation volume. 3. Study Participants:
The study involves 28 adult inpatients confined to bed. Participants will use the Nintendo Ring Fit™, which provides a motion-tracking gamified rehabilitation program, with an exercise plan personalized to each patient's physical condition. 4. Research Methodology:
Exercise Protocol: Participants will engage in a personalized exercise program for two weeks using the Nintendo Ring Fit. Each session lasts approximately 30 minutes, occurs once daily, and is supervised by a therapist. Exercise intensity and type are tailored to the patient's physical condition to ensure safety. 5. Safety and Efficacy Monitoring: Participants' physical function (e.g., strength, mobility) is tracked throughout the study. Patients are continuously monitored for any discomfort or adverse events during exercise sessions. Motor responses are closely observed to ensure utmost safety. 6. Study Duration:
The study runs from October 2024 to October 2025, during which participants undergo rehabilitation exercises using motion-tracking exergames. 7. Expected Results:
The study is expected to demonstrate that digital rehabilitation programs are a feasible and safe adjunct treatment option for bedridden inpatients. Furthermore, the findings will contribute to improving in-hospital rehabilitation practices and promoting physical recovery. 8. Safety Considerations:
All exercises in this study are designed with safety as the highest priority, with intensity strictly maintained at a very low to low level. If patients experience discomfort or adverse events during a session, exercise is immediately paused, and necessary medical actions are taken. All sessions are conducted under the direct supervision of a healthcare professional.
详细描述
- Study Title: Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study
- Objective:
This study aims to evaluate the feasibility and safety of an individually prescribed in-bed exergaming rehabilitation program using Nintendo Ring Fit Adventure™ (NFA) for severely deconditioned inpatients. The study will analyze the intervention's feasibility, safety profile, and concurrent changes in physical function and patient satisfaction. 3. Senior Investigator: Dr. Won Kim Co-investigators: Dr. Yong Hoe Koo, Dr. Woo Chul Son Agency: Asan Medical Center, Seoul Study 4. Study Design: A prospective, single-center, feasibility study of approximately 20 participants meeting the inclusion and exclusion criteria. 5. Background of the Study Advances in acute and critical care medicine have improved survival rates; however, many patients experience profound functional decline, such as Intensive Care Unit-Acquired Weakness (ICU-AW) and severe deconditioning. This behavioral limitation implies several risk factors, including a higher risk of falls, hospital-acquired infections, and a significantly reduced quality of life. Even after hospital discharge, many patients fail to regain their premorbid physical function.
To address these issues, early rehabilitation and mobilization are strongly advocated. Previous studies have demonstrated that early mobilization, ranging from passive range of motion to active transfers, can shorten ICU stays and improve functional recovery. However, delivering sufficient rehabilitation doses to profoundly weak, non-ambulatory inpatients is often limited by systemic constraints, such as staffing shortages and patient fatigue.
By supplementing these conventional therapy limitations, this study explores the feasibility of technology-assisted rehabilitation using a commercially available exergame (Nintendo Ring Fit Adventure™). This study aims to quantitatively evaluate the intervention's feasibility, review its safety, and assess patient compliance and satisfaction in a high-acuity clinical setting. 6. Research Objectives:
To evaluate the feasibility and safety of implementing a commercial exergame-based in-bed rehabilitation program for severely deconditioned post-transplant inpatients, and to observe its effects on physical function and user satisfaction. 7. Estimated Duration of Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Study Participants
- •Inclusion Criteria:
- •Organ transplant recipients. Aged 18 years or older who have provided written informed consent. Patients who required critical care. Patients with restricted mobility, defined as an FAC score of 3 or less (unable to ambulate independently).
排除标准
- •Inability to follow instructions due to cognitive impairment or sedation. Hemodynamic instability precluding rehabilitation. Severe musculoskeletal limitations (e.g., unstable fractures, recent amputations) preventing exercise participation.
- •Significant sensory impairments (e.g., severe hearing or visual loss) hindering interaction with the exergaming system.
研究组 & 干预措施
Intervetional
Since study includes single arm, all participants will receive 2 weeks of exergaming rehabilitation intervetion
干预措施: Rehabilitation (Device)
结局指标
主要结局
Session Completion Rate
时间窗: Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks)
Feasibility and adherence were assessed by the number of completed and discontinued exercise movements and completed sessions during the intervention period. A session was considered interrupted if terminated before completing the planned exercise set. Completed sessions rate: percentage of 10 planned sessions finished per each participants Outcomes are percentages (0-100); higher values indicate better adherence
Exercise Movement Completion Rate
时间窗: Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks)
Feasibility and adherence were assessed by the number of completed and discontinued exercise movements during the intervention period. An exercise movement was considered discontinued if the participant stopped or was unable to complete the specific repetitions or prescribed movements within a session. Exercise movement completion rate is the percentage of prescribed movements successfully finished per each participant. Outcomes are percentages (0-100); higher values indicate better adherence.
次要结局
- Net Exercise Time(Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions))
- Medical Research Council Sum Score (MRC-SS)(Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions))
- Functional Ambulatory Category (FAC)(Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions))
- ICU Mobility Scale(Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions))
研究者
Won Kim
Associate Professor
Asan Medical Center