UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058856 |
|---|---|
| Receipt number | R000067297 |
| Scientific Title | Early Mobilization Practices in Critically Ill Children in Japan: A One-day Point-Prevalence Study |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/21 12:33:15 |
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Basic information
Public title
Early Mobilization Practices in Critically Ill Children in Japan: A One-day Point-Prevalence Study
Acronym
EMJ PoP-p study
Scientific Title
Early Mobilization Practices in Critically Ill Children in Japan: A One-day Point-Prevalence Study
Scientific Title:Acronym
EMJ PoP-p study
Region
| Japan |
Condition
Condition
Pediatric patients admitted to ICUs on a designated study day
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To clarify the implementation rate of early rehabilitation in critically ill pediatric patients admitted to intensive care units in Japan, including PICUs.
Basic objectives2
Others
Basic objectives -Others
2) To investigate the assessments performed and the content of rehabilitation provided.
3) To investigate the barriers to rehabilitation based on patient information in cases where rehabilitation could not be implemented.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of rehabilitation.
Key secondary outcomes
Intensive Care Unit Mobility Scale (IMS):
For each patient, the level of activity on the designated study day will be evaluated using the IMS (a description of the scale will be attached in the data entry sheet).
Even in cases where basic activities such as independent sitting are difficult, or in infants/toddlers with unstable gait, evaluation will still be conducted using the IMS; however, during analysis, these cases may be excluded or subjected to subgroup analyses depending on the number of such patients.
If the patient performed in-bed exercises, information will be collected regarding the specific type of activity, including range of motion exercises, positioning, respiratory physiotherapy, developmental support, strength training, neuromuscular electrical stimulation (NMES), or in-bed cycle ergometer training.
In addition, information on the presence or absence of adverse events during rehabilitation will also be collected.
Barriers to Rehabilitation:
Barriers to the implementation of rehabilitation will be identified and recorded.
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
| 1 | months-old | < |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients admitted to ICUs at each participating facility on a designated study day will be included as study subjects.
Pediatric patients are defined as those aged 0 to 15 years.
Key exclusion criteria
Patients who were admitted to the ICU for reasons such as bed control, and who would not normally require ICU admission, will be excluded.
For example, patients scheduled to be discharged from the ICU within 24 hours.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Miyagishima |
Organization
Japan Healthcare University
Division name
Faculty of Health Sciences
Zip code
062-0053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo-shi, Hokkaido
TEL
011-351-6100
s-miyagishima@jhu.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Miyagishima |
Organization
Japan Healthcare University
Division name
Faculty of Health Sciences
Zip code
062-0053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo-shi, Hokkaido
TEL
011-351-6100
Homepage URL
s-miyagishima@jhu.ac.jp
Sponsor or person
Institute
Japan Healthcare University
Institute
Department
Personal name
Saori Miyagishima
Funding Source
Organization
Japan Healthcare University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Healthcare University
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo-shi, Hokkaido
Tel
011-351-6100
rinri@jhu.ac.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 | 01 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective registration, multicenter study, ethics approval obtained.
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067297
