UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047980 |
|---|---|
| Receipt number | R000054663 |
| Scientific Title | Predecting prognosis for the patients with stroke |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2024/11/28 10:25:57 |
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Basic information
Public title
Developing the novel predicting prognosis method for the patients with stroke
Acronym
Developing the novel predicting prognosis method for the patients with stroke
Scientific Title
Predecting prognosis for the patients with stroke
Scientific Title:Acronym
Predecting prognosis for the patients with stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Geriatrics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a novel gait prognostic indicator that determines the combination of physical function assessment performed early after the onset of disease and the assessment of geriatric syndromes, frailty, sarcopenia, and undernutrition.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Rankin Scale at one-year after stroke
Key secondary outcomes
Functional Ambulation Classification at one-year after stroke
modified Rankin Scale at 3-month after stroke
Functional Independent Measures at acute hospital discharge
Trunk Control Test at acute hospital discharge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to Konan Medical Center within 7 days after stroke or cerebral hemorrhage
Key exclusion criteria
Patients with severe cognitive impairment that makes it difficult to perform physical function measurement and nutritional assessment
Those who opt for palliative care and do not wish to undergo aggressive treatment for stroke
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
5731136
Address
Uyamahigashicho 18-89, Hirakata, Osaka
TEL
0728562362
masafumi.nozoe@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Knasai Medical University
Division name
Faculty of Rehabilitation
Zip code
5731136
Address
Uyamahigashimachi, 18-89, Hirakata, Osaka
TEL
0728562362
Homepage URL
masafumi.nozoe@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Niigata University of Health and Welfare
Konan Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Ethics Review Committee
Address
2-5-1 Shinmachi, Hirakata-shi, Osaka
Tel
0728040101
rinriirb@hirakata.kmu.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
甲南医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 08 | 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
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054663
