Feasibility and Safety Validation Study of a Rehabilitation Program and Platform Using Digital Devices for Recovery of Bedridden Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
Study Title Rehabilitation Program for Bedridden Patients Using Digital Devices
Study Purpose This study aims to evaluate the effectiveness of a rehabilitation program using digital devices and apps for bedridden patients in a hospital setting. The goal is to determine if digital rehabilitation can help improve physical function and contribute to recovery for patients who are unable to move easily.
Study Participants The study will involve 20 adult patients who are bedridden and hospitalized. Participants will use the provided app, which delivers a customized rehabilitation exercise program.
Study Methodology Exercise Protocol: Patients will follow a personalized exercise program through the MORA app, performing the exercises twice daily for a period of 2 weeks. Each session will last approximately 30 minutes and will be tailored to the patient's physical condition to ensure safety.
Safety and Effectiveness Monitoring: The study will track the patients' physical function (e.g., strength, mobility) and monitor for any discomfort or adverse effects that may arise during the exercise sessions.
Study Duration The study will run from September 2024 to December 2025. During this period, participants will engage in rehabilitation exercises using the digital app.
Expected Outcomes This study will demonstrate whether digital rehabilitation can be a safe and effective treatment option for bedridden patients in the hospital. The findings are expected to help improve physical recovery for these patients and contribute to enhancing rehabilitation practices within hospital settings.
Safety Considerations The exercises in this study are designed with safety in mind and will be adjusted to a low intensity. Any discomfort or adverse effects will be monitored closely, and immediate action will be taken if necessary. All exercises will be conducted under the supervision of healthcare professionals.
详细描述
Summary of the Research Plan Title: Feasibility and Safety Validation Study of a Rehabilitation Program and Platform Using Digital Devices for Recovery of Bedridden Patients
Objectives:
This study aims to analyze the physical function characteristics of bedridden patients and to develop a rehabilitation program using the MORA app to validate the feasibility and safety of the rehabilitation program and platform.
Principal Investigator: Dr. Kim Won Co-investigators: Dr. Cha Seungwoo, Dr. Lee Chaerin Institution: Seoul Asan Medical Center Study Participants: Hospitalized patients at Seoul Asan Medical Center with a Functional Ambulatory Category (FAC) score of 3 or below and bedridden.
Study Design: A prospective cohort clinical study involving 20 participants who meet the inclusion and exclusion criteria.
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
- •Adult patients (aged ≥19 years)
- •Hospitalized patients with a Functional Ambulatory Category (FAC) score of ≤ 3 and who are bedridden.
排除标准
- •Patients with significant cognitive impairment that prevents them from operating the app.
- •Patients with severe pain or limited range of motion preventing participation in physical activity.
- •Patients with severe biomechanical instability.
- •Patients with significant sensory impairments (e.g., visual or auditory) that would hinder participation in the rehabilitation program.
研究组 & 干预措施
Intervention
The rehabilitation program will utilize the MORA app to create individualized interventions based on each patient's physical capabilities.
干预措施: Rehabilitation (Behavioral)
结局指标
主要结局
Feasibility
时间窗: From enrollment to the end of treatment at 2 weeks
Patient adherence was defined as the percentage of completed exercise time relative to the total prescribed exercise time.
次要结局
- Number of Adverse Events(From enrollment to the end of treatment at 2 weeks)
- Safety(From enrollment to the end of treatment at 2 weeks)
研究者
Won Kim
Associate Professor
Asan Medical Center