UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046083 |
|---|---|
| Receipt number | R000052597 |
| Scientific Title | The reliability and validity of Japanese version physical function evaluation score. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/05/21 10:36:42 |
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Basic information
Public title
The reliability and validity of Japanese version physical function evaluation score.
Acronym
The reliability and validity of Japanese version physical function evaluation score.
Scientific Title
The reliability and validity of Japanese version physical function evaluation score.
Scientific Title:Acronym
The reliability and validity of Japanese version physical function evaluation score.
Region
| Japan |
Condition
Condition
Patients at the ICU discharge
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the useful physical function scores for reliability, validity, and predicting discharge home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability, Validity, Discharge home or not
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Assessement within 24 hours before or after ICU discharge after ICU admission more than 2days.
2. Consciouness (obey the order of De Jonghe criteria more than 2 out of 5).
3. Two observers can assess the physical function.
Key exclusion criteria
1. consciousness disorder including central nervous disorde or deliriumr.
2. Short prognosis expectation at the ICU discharge.
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University Hospital
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ku, Kobe, 650-0017, Japan
TEL
08016010115
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University Hospital
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ku, Kobe, 650-0017, Japan
TEL
08016010115
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
Clinical Translational Research Center
Tel
078-382-6669
kainyu@med.cobe-u.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
| 2022 | Year | 02 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study to compare the physical function score at the ICU discharge.
Management information
Registered date
| 2021 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052597
