UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056961 |
|---|---|
| Receipt number | R000064314 |
| Scientific Title | Impact of Prestroke Care Dependency and Poststroke Rehabilitation on Long-Term Prognosis |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/03/08 15:39:13 |
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Basic information
Public title
Impact of Prestroke Care Dependency and Poststroke Rehabilitation on Long-Term Prognosis
Acronym
Impact of Prestroke Care Dependency and Poststroke Rehabilitation on Long-Term Prognosis
Scientific Title
Impact of Prestroke Care Dependency and Poststroke Rehabilitation on Long-Term Prognosis
Scientific Title:Acronym
Impact of Prestroke Care Dependency and Poststroke Rehabilitation on Long-Term Prognosis
Region
| Japan |
Condition
Condition
Cerebral Infarction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the impact of prestroke care dependency and the intensity, quantity, and content of poststroke rehabilitation on functional outcomes in patients with cerebral infarction, using a multicenter cohort with an adequate sample size.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Rankin Scale at 1 year after stroke
Key secondary outcomes
Readmission within one year after onset
Stroke recurrence within one year after onset
Occurrence of cardiovascular events within one year after onset
Patient-reported outcomes at one year after onset
Incidence of falls within one year after onset
Adverse events during hospitalization
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
1. Patients with cerebral infarction who were hospitalized and prescribed rehabilitation within 7 days of onset.
2. Patients aged 65 years or older at the time of consent acquisition.
3. Patients who, after receiving a thorough explanation of the study, provided informed consent based on a full understanding and their own free will.
Key exclusion criteria
1. Patients hospitalized for transient ischemic attack (including those who developed cerebral infarction after hospitalization for transient ischemic attack).
2. Patients hospitalized for intracerebral hemorrhage or subarachnoid hemorrhage.
3. Patients for whom end-of-life care is indicated.
4. Patients whose initial rehabilitation intervention occurred more than 8 days after admission.
5. Patients discharged within one week of admission.
6. Patients who developed cerebral infarction during hospitalization at their own or another facility.
7. Individuals who declined participation in the study.
8. Patients deemed unsuitable for inclusion by the principal investigator.
Target sample size
3000
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
573-1136
Address
Uyamahigashicho 18-89, Hirakata, Osaka
TEL
0728562362
masafumi.nozoe@gmail.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ogino |
Organization
Hyogo Medical University
Division name
Faculty of Rehabilitation
Zip code
650-0045
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
0783043000
Homepage URL
to-ogino@hyo-med.ac.jp
Sponsor or person
Institute
Kansai Medical Univerisity
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Medical University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | 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
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hoyogo Medical Univerisity Hospital
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064314
