Feasibility and Safety Validation Study of a Rehabilitation Program and Platform Using Digital Devices for Recovery of Bedridden Patients
Phase: NA
Conditions: ICU Acquired Weakness (ICUAW)
Sponsor: Asan Medical Center

Cover Page 
 
Official Title: Feasibility and safety validation study of a rehabilitation program and platform using 
digital devices for Recovery of Bedridden Patients NCT Number: NCT06849765 Document Date: 
2026.01.08. 
Principal Investigator: Won Kim, Associate Professor, Department of Rehabilitation Medicine, Asan 
Medical Center  
Study Implementation Institution: Asan Medical Center  
 
 

 
Study Protocol and Statistical Analysis Plan 
 
1. Study Overview 
 
Background: Many hospitalized patients remain bedridden after surgery, leading to muscle 
weakness and complications like pneumonia. Current rehabilitation is limited by cost and 
manpower. Digital therapeutics offer a solution to overcome time, space, and economic 
limitations. 
 
Objective: To verify the feasibility and safety of a rehabilitation program and platform 
(MORA application) for the recovery of bedridden patients and to analyze their physical 
functional characteristics. 
 
Study Design: Prospective cohort clinical study (Pilot Study). 
 
Study Duration: From IRB approval date to December 31, 2025. 
 
2. Participants 
 
Target Sample Size: 28 participants (calculated considering dropout rates for a pilot study). 
 
Inclusion Criteria: 
o 
Adult patients aged 19 years or older admitted to Asan Medical Center. 
o 
Patients in a bedridden state with a Functional Ambulatory Category (FAC) score of 
3 or less. 
o 
Note: FAC 3 indicates a state requiring a guardian for supervision without physical 
contact during ambulation. 
 
Exclusion Criteria: 
o 
Unable to follow app movements due to cognitive decline. 
o 
Pain or limited range of motion in upper/lower limbs preventing participation. 
o 
Biomechanically unstable patients. 
o 
Difficulty cooperating due to vision or hearing impairment. 
  

3. Interventions (Methods) 
 
Rehabilitation Tool: MORA Application. 
 
Protocol: 
o 
Frequency: Twice a day (morning, afternoon), 20 sessions total over 2 weeks. 
o 
Duration: Within 20 minutes per session (10-15 movements per session). 
o 
Supervision: A researcher visits for the first 5 days to guide app execution and 
movements. Afterwards, patients perform exercises autonomously with push 
notifications/reminders. 
o 
Customization: Exercise programs are prescribed based on the patient's functional 
capability evaluated at enrollment. 
 
4. Outcome Measures 
Assessments are conducted at baseline (Screening/Visit 1), 1 week (Visit 7), and 2 weeks/completion 
(Visit 13). 
 
Clinical Assessments: 
o 
Manual Muscle Test (MMT), Medical Research Council Sum Score (MRC-SS). 
o 
ASAN Mobility Score, ICU Mobility Scale, FAC. 
o 
Sit to Stand test, Single Leg Raise (SLR) (5-second hold capability), Bridge capability. 
o 
Hand Grip Strength, Knee Extensor Test. 
o 
10-Meter Walk Test (10MWT). 
o 
Mini-Mental State Examination (MMSE), Numeric Rating Scale (NRS) for pain. 
 
Video Data: 
o 
Exercise performance is recorded and anonymized for analysis. 
 
Patient-Reported Outcomes (PROs): 
o 
Satisfaction with MORA app, acceptance, difficulty, understanding. 
o 
Mood, Quality of Life, subjective health status. 
 
Safety & Adherence: 

o 
Adverse events (falls, dizziness, etc.). 
o 
Participation rate, reasons for discontinuation, heart rate monitoring (Polar). 
  
5. Statistical Analysis Plan 
 
Software: SPSS and R programs will be used. 
 
Significance Level: p < 0.05. 
 
Descriptive Statistics: Patient compliance, severity, and assistance levels will be described 
descriptively. 
 
Normality Test: Shapiro-Wilk test. 
 
Categorical Variables: Analyzed using Chi-square test and Logistic regression. 
 
Continuous Variables: 
o 
Analyzed using Mann-Whitney U test, Wilcoxon signed-rank test (for pre-post 
comparison), Friedman test, Kruskal Walli’s test, and Spearman correlation. 
 
 
Informed Consent Form Information 
 
1. Study Title and Investigators 
 
Title: Feasibility and safety validation study of a rehabilitation program and platform using 
digital devices for Recovery of Bedridden Patients. 
 
Principal Investigator: Won Kim (Dept. of Rehabilitation Medicine). 
 
2. Purpose of the Study 
 
This study explores the possibility of in-bed rehabilitation using the MORA application. 
 
It aims to verify the feasibility and safety of the rehabilitation program for bedridden patients. 
 

3. Study Procedures 
Participation involves the following visits and evaluations: 
 
Screening: Review of inclusion/exclusion criteria, demographics, and medical history. 
 
Visit 1 (Baseline Evaluation): Physical function tests (MMT, FAC, Grip strength, etc.), 
cognition (MMSE), and pain (NRS) assessments. 
 
Visit 2-6 (Supervised Intervention): A researcher visits to conduct the exercise intervention 
using the MORA app. Video data is collected on Visit 2 and Visit 6. 
 
Visit 7 (Interim Evaluation): Re-assessment of physical functions and surveys. 
 
Visit 8-11 (Autonomous Intervention): Patient performs exercises autonomously using the 
app. 
 
Visit 12 (Check-up): Researcher visit for intervention and video data collection. 
 
Visit 13 (Final Evaluation): Final physical assessments, Quality of Life survey (EQ-5D), and 
satisfaction survey. 
 
4. Risks and Discomforts 
 
Potential risks include temporary dyspnea, tachycardia, blood pressure changes, falls, or 
dislodgement of therapeutic devices. 
 
However, the risk is considered very low as the exercises are low-intensity and performed 
while lying down or sitting. 
 
If adverse events occur requiring hospitalization due to the study, the research team will 
cover the costs. 
 
5. Benefits and Costs 
 
Benefits: Personalized exercise prescription and the ability to perform rehabilitation without 
a therapist's constant presence. 
 
Costs: There is no cost to the participant for the rehabilitation treatment and evaluations 
conducted for the study. 
 
Compensation: 100,000 KRW will be provided upon completion of all study procedures. If 
participation stops due to unavoidable reasons (e.g., discharge), the amount is paid at the 

last visit. 
  
6. Confidentiality 
 
Collected data (age, diagnosis, functional level, video data) will be stored on a computer. 
 
Data will be encrypted and shared only with authorized researchers (including EverEx 
researchers) via a secure link (Asan Works Drive) to prevent leakage. 
 
All data will be stored for 3 years after study completion and then destroyed. 
 
7. Voluntary Participation and Withdrawal 
 
Participation is voluntary. You may refuse or withdraw at any time without penalty or impact 
on your standard treatment.