UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051285 |
|---|---|
| Receipt number | R000055051 |
| Scientific Title | Trail making test part A is associated with home discharge in patients with acute cerebral infarction |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2023/12/11 18:38:50 |
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Basic information
Public title
Processing speed tool is associated with home discharge in acute cerebral infarction
Acronym
Attentional function is associated with home discharge in acute cerebral infarction
Scientific Title
Trail making test part A is associated with home discharge in patients with acute cerebral infarction
Scientific Title:Acronym
TMT-A is associated with home discharge in patients with acute cerebral infarction
Region
| Japan |
Condition
Condition
Patients with cerebral infarction
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the trail making test part A is associated with home discharge in patients with acute cerebral infarction.
Basic objectives2
Others
Basic objectives -Others
To identify patient characteristics that predict home discharge in patients with acute cerebral infarction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discharge Destination (Home or Not-Home)
Trail Making Test part A
Key secondary outcomes
Age, NIHSS, BRS, MMSE, Number of people living together
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute cerebral infarction patients admitted to the stroke care unit
Key exclusion criteria
(1) not capable of performing the TMT-A at the initial evaluation
(2) not capable of performing the MMSE at the initial evaluation
(3) a clear reduction in the NIHSS score during hospitalization
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | Syuhei |
| Middle name | |
| Last name | Chiba |
Organization
Kitasato University Hsopital
Division name
Rehabilitation Department
Zip code
252-0329
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
1zerozero81008@gmail.com
Public contact
Name of contact person
| 1st name | Syuhei |
| Middle name | |
| Last name | Chiba |
Organization
Kitasato University Hospital
Division name
Rehabilitation Department
Zip code
252-0329
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
Homepage URL
1zerozero81008@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8111
1zerozero81008@gmail.com
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 | 10 | 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
164
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
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Logistic regression analysis was performed using three models to predict discharge home. Detailed models are described as follows:
Model 1:age, NIHSS, BRS, number of people living together, MMSE
Model 2:age, NIHSS, BRS, number of people living together, TMT-A
Model 3: age, NIHSS, BRS, number of people living together, MMSE, TMT-A
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055051
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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