UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058928 |
|---|---|
| Receipt number | R000067394 |
| Scientific Title | Validation of a Prediction Score for Independent Walking Until Discharge or Transfer in Critically Ill Patients Requiring Mechanical Ventilation: A Multicenter Retrospective Cohort Study |
| Date of disclosure of the study information | 2025/09/27 |
| Last modified on | 2025/09/27 09:52:19 |
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Basic information
Public title
Validation of a Prediction Score for Independent Walking Until Discharge or Transfer in Critically Ill Patients Requiring Mechanical Ventilation: A Multicenter Retrospective Study
Acronym
WALK-MV score Study
Scientific Title
Validation of a Prediction Score for Independent Walking Until Discharge or Transfer in Critically Ill Patients Requiring Mechanical Ventilation: A Multicenter Retrospective Cohort Study
Scientific Title:Acronym
WALK-MV score Study
Region
| Japan |
Condition
Condition
Mechanically ventilated critically ill patients in the ICU
Classification by specialty
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a prediction score for independent walking until discharge or transfer in critically ill patients requiring mechanical ventilation, and to evaluate the utility of this model in a multicenter retrospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether or not walking independence was achieved before discharge or transfer
Key secondary outcomes
Discrimination, calibration, clinical utility, and internal validation of a walking independence prediction model
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Mechanical ventilation for 48 or more consecutive hours
2. Age: 18 years or older
3. Gender: Any
4. Able to walk before hospitalization (including with a walking aid)
5. Doctor prescribed rehabilitation
Key exclusion criteria
1. Discharge from the ICU or emergency center within 72 hours
2. Cerebrovascular accident
3. Persons receiving mechanical ventilation prior to admission
4. In-hospital death
5. Spinal, pelvic, or lower limb fractures resulting in lower limb unloading
6. Amputation of upper or lower limbs
7. Irreversible (or prolonged) loss of consciousness
8. Spinal cord injury
9. Malignant tumors or other diseases with a life expectancy of 6 months or less
10. Post-transplant surgery (due to this hospitalization)
11. Direct transfer from the ICU or emergency center
12. Other individuals deemed inappropriate by researchers to be research subjects
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Yoshinaga |
Organization
NHO Ureshino medical center
Division name
Rehabilitation
Zip code
843-0393
Address
4279-3 Shimojuku, Ureshino-cho, Ureshino City, Saga
TEL
0954-43-1120
yoshinaga.ryuji.dx@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Yoshinaga |
Organization
NHO Ureshino Medical Center
Division name
Rehabilitation
Zip code
843-0393
Address
4279-3 Shimojuku, Ureshino-cho, Ureshino City, Saga
TEL
0954-43-1120
Homepage URL
yoshinaga.ryuji.dx@mail.hosp.go.jp
Sponsor or person
Institute
NHO Ureshino Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (Early-Career Scientist, Grant Number: 25K20866)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of NHO Ureshino Medical Center
Address
4279-3 Shimojuku, Ureshino-cho, Ureshino City, Saga
Tel
0954-43-1120
yoshinaga.ryuji.dx@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study.
The primary endpoint is independent walking until discharge or transfer, analyzed using Fine-Gray proportional hazards model.
A prediction score was created based on the regression coefficients of the Fine-Gray model (mainly referring to the hazard ratio), and a prediction model for the acquisition of independent walking was constructed.
Data from other centers will be transferred securely by hand-delivered USB drives.
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067394
