NCT06937463

Brief Summary

Study title: Customized Evidence-Based Motion Recognition Rehabilitation Exercise System for Bed Stabilization Patients the purpose of the study This study aims to evaluate the effectiveness of rehabilitation programs using motion recognition-based games for patients who are bedridden in hospital settings. The main purpose of the study is to determine whether digital rehabilitation can substantially contribute to the improvement and recovery of physical function in patients with limited physical functioning. a study participant The study involved 28 adult patients who were hospitalized while lying in bed at a hospital. Participants use Nintendo Ring Fit, which provides a motion-aware-based game rehabilitation exercise program, and a personalized exercise plan is provided for each patient's physical condition. research methodology Exercise Protocol: Participants will perform a personalized exercise program for two weeks through Nintendo Ring Fit. The exercise lasts about 30 minutes, once a day and is supported by a therapist. Exercise intensity and type are adjusted to suit the patient's physical condition so that they proceed safely. Monitoring safety and effectiveness: Keep track of participants' physical functions (e.g., strength, mobility, etc.) during the study, and constantly monitor for any inconveniences or side effects that may occur during exercise sessions. This closely checks patients' motor responses and ensures safety. the duration of the study The study runs from September 2024 to December 2025, during which participants will undergo rehabilitation exercises using motion recognition-based games. Estimated results The study is expected to demonstrate that digital rehabilitation programs can be a safe and effective treatment option for patients who are bedridden in hospital settings. In addition, the findings will contribute to improving in-hospital rehabilitation practices and promoting physical recovery. Safety Considerations All exercises conducted in this study are designed with safety as the top priority, and exercise intensity is adjusted to low intensity. If patients experience discomfort or side effects during the exercise, they are monitored closely and allowed to take the necessary action immediately. All exercises are conducted safely under the supervision of a medical professional.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 20, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

bed-ridden patientsMotion recognition

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Enter the actual exercise time and number of exercises for the total exercise time to record whether the patient complies with the rehabilitation program.

    From enrollment to end of two-week treatment

Secondary Outcomes (1)

  • Safety

    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

  • +5 more other outcomes

Study Arms (1)

This is a study on the recovery of physical function in bed patients through a digital rehabilitatio

EXPERIMENTAL

This is a study on the recovery of physical function in bed patients through a digital rehabilitation exercise system

Behavioral: Rehabilitation

Interventions

RehabilitationBEHAVIORAL

This is a study on the recovery of physical function in bed patients through a digital rehabilitation exercise system

This is a study on the recovery of physical function in bed patients through a digital rehabilitatio

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Those who are unable to cooperate in rehabilitation exercise programs due to inadequate levels of consciousness or cognition - those who have persistent biological instability
  • A person who is unable to perform most of the exercise programs due to severe limitation of muscle strength or range of motion of the joint, disability of amputation, etc
  • A person who needs to limit the movement required for the rehabilitation exercise program due to fracture or instability of the skeletal system- A person who is unable to cooperate with the rehabilitation exercise program due to poor vision or hearing
  • Patients on mechanical ventilation for 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Songpa-gu, Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

won Kim (Associate professor), PhD

CONTACT

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

April 20, 2025

First Posted

April 22, 2025

Study Start

April 25, 2025

Primary Completion

September 30, 2025

Study Completion

October 1, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

All individual patient data (IPD) used in this study will be handled in compliance with domestic privacy protection laws and relevant regulations. The privacy of study participants will be strictly safeguarded, and their personal information will not be used for purposes other than the study. When sharing data, only de-identified data that has been approved by the researchers after adequate request will be provided, and privacy protection and security will be prioritized throughout the process.

Locations