UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051245 |
|---|---|
| Receipt number | R000058440 |
| Scientific Title | Investigation of factors affecting early mobilization in patients with acute cerebrovascular disease ~Using body composition~ |
| Date of disclosure of the study information | 2023/06/04 |
| Last modified on | 2023/06/02 17:08:04 |
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Basic information
Public title
Investigation of factors affecting early mobilization in patients with acute cerebrovascular disease ~Using body composition~
Acronym
Investigation of factors affecting early mobilization in patients with acute cerebrovascular disease ~Using body composition~
Scientific Title
Investigation of factors affecting early mobilization in patients with acute cerebrovascular disease ~Using body composition~
Scientific Title:Acronym
Investigation of factors affecting early mobilization in patients with acute cerebrovascular disease ~Using body composition~
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the prognostic factors of patients with acute cerebrovascular disease admitted to our SCU ward in the group that was able to leave the bed within 48 hours after admission (early withdrawal group) and the group that took more than 3 days to leave the bed (delayed bed withdrawal group) based on the data at the start of rehabilitation using the body composition such as limb muscle mass, SMI, and muscle quality measured under regular medical care.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body composition: impedance, body water content, muscle mass, body composition, fat mass, extracellular water ratio
Hemiplegic function evaluation: BRS-T
Key secondary outcomes
handedness, age, gender,
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
| 65 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute stroke patients admitted to SCU in January 2023~December 2024
Key exclusion criteria
Patients with pacemakers
Patients with cerebrovascular disease in their anamnesis
Patients with difficulty measuring body composition
Patients who the researcher deems inappropriate to be included in this study
Patients who have refused to participate in this study
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | syunsuke |
| Middle name | |
| Last name | sasaki |
Organization
Dokkyo Medical Universitiy hospital
Division name
Department of Rehabilitation
Zip code
3210293
Address
880 Kitakobayashi, Shimotsuga-gun Tochigi
TEL
0282861111
s-shun@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | syunsuke |
| Middle name | |
| Last name | sasaki |
Organization
Dokkyo Medical Universitiy hospital
Division name
Department of Rehabilitation
Zip code
3210293
Address
880 Kitakobayashi, Shimotsuga-gun Tochigi
TEL
0282861111
Homepage URL
s-shun@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical Universitiy
Institute
Department
Personal name
Funding Source
Organization
NON
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
Reserch ethics committee of dokkyo medical university
Address
880 Kitakobayashi, Shimotsuga-gun Tochigi
Tel
0282861111
r-kenkyu@dokkyomed.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
| 2023 | Year | 06 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational studies
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058440
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
