UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059213 |
|---|---|
| Receipt number | R000067708 |
| Scientific Title | A Multicenter Longitudinal Study on Prognostic Factors and Prediction Model Development for Functional Outcomes in Subacute Stroke Patients (PRIMES: Precision Rehabilitation with Integrated Models for Engagement in Stroke) |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/10/10 22:50:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on factors affecting recovery and prognosis in patients with subacute stroke (PRIMES)
Acronym
PRIMES
Scientific Title
A Multicenter Longitudinal Study on Prognostic Factors and Prediction Model Development for Functional Outcomes in Subacute Stroke Patients (PRIMES: Precision Rehabilitation with Integrated Models for Engagement in Stroke)
Scientific Title:Acronym
PRIMES
Region
| Japan |
Condition
Condition
Patients with cerebral infarction or intracerebral hemorrhage admitted to a rehabilitation ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore factors influencing physical function and activities of daily living (ADL) in stroke patients admitted to a rehabilitation ward, to identify prognostic factors for poor outcomes, and to develop a prediction model for prognosis. Furthermore, cutoff values and MIC necessary for clinical decision-making will be calculated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL ability at discharge from the rehabilitation ward (FIM, mRS)
ADL ability at 1 year after stroke onset (mRS, FAI)
Key secondary outcomes
Walking ability at discharge from the rehabilitation ward (FAC)
Walking ability (FAC), Adverse events (stroke recurrence, rehospitalization, cardiovascular events, death, and falls), Care-need level, QOL (EQ-5D), Caregiver burden (CRA-J-10) at 1 year after stroke onset
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
1. Age 18 years or older
2. Patients with cerebral infarction or intracerebral hemorrhage admitted to a rehabilitation ward to receive rehabilitation
Key exclusion criteria
1. Patients who required assistance for walking before stroke onset (FAC < 3)
2. Patients with subarachnoid hemorrhage
3. Patients who did not provide informed consent
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Hyogo medical University
Division name
Faculty of Rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3135
masafumi.nozoe@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kubo |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
6580001
Address
6-2-23 Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
078-413-3691
Homepage URL
hiro.k16862@gmail.com
Sponsor or person
Institute
Hyogo medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nishi-Kinen Port-island Rehabilitation Hospital
Nishinomiya Kyoritsu Rehabilitation Hospital
Senri Chuo Hospital
Tsukuba Central Hospital
Hirosaki Stroke and Rehabilitation Center
Musashimurayama Hospital
Itami Seifu Hospital
Hatsudai Rehabilitation Hospital
Itami Kosei Neurosurgical Hospital
Shin-Sapporo Neurosurgical Hospital
Central Japan International Medical Center
Higashiosaka Hospital
JCHO Hoshigaoka Medical Center
Saitama Sekishinkai Hospital
Nerima Ken-ikukai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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 | 09 | Month | 30 | 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
| 2025 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter observational study involving stroke patients admitted to rehabilitation wards in Japan. The primary outcomes are ADL and walking ability, while the secondary outcomes include adverse events, quality of life, and caregiver burden at 1 year after stroke onset.Furthermore, this study aims to contribute to the development of prognostic prediction models, as well as the determination of cutoff values and MIC.
Management information
Registered date
| 2025 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067708
