Feasibility and Safety of Digital Rehab Platform for Bedridden Patients

NCT06849765 | Completed Results

• 1 other identifier: S2024-1729-0002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ICU Acquired Weakness (ICUAW)

Keywords

Intensive Care Unit Acquired weakness; Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Patient adherence was defined as the percentage of completed exercise time relative to the total prescribed exercise time.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (1)

• Number of Adverse Events

  From enrollment to the end of treatment at 2 weeks

Other Outcomes (8)

• Medical Research Council Sum Score (MRC-SS)

  From enrollment to the end of treatment at 2 weeks

• Functional Ambulatory Category (FAC)

  From enrollment to the end of treatment at 2 weeks

• Hand Grip Strength Test

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

The rehabilitation program will utilize the MORA app to create individualized interventions based on each patient's physical capabilities.

Behavioral: Rehabilitation

Interventions

Rehabilitation BEHAVIORAL

The rehabilitation program will utilize the MORA app to create individualized interventions based on each patient's physical capabilities.

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged ≥19 years)
• Hospitalized patients with a Functional Ambulatory Category (FAC) score of ≤ 3 and who are bedridden.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• EverEx Inc.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Won Kim, MD, PhD
• Organization: Asan Medical Center

duocl79@gmail.com

02-3010-3769

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: February 27, 2025
• Study Start: March 24, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 1, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)