UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056696 |
|---|---|
| Receipt number | R000064809 |
| Scientific Title | Prognostic Prediction for Stroke Patients Using Machine Learning |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2026/07/18 04:54:25 |
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Basic information
Public title
Validation of a Prognostic Model for Discharge Functional Independence Measure in Stroke Patients Considering the Impact of Aging
Acronym
Validation of a Prognostic Model for Discharge Functional Independence Measure in Stroke Patients Considering the Impact of Aging
Scientific Title
Prognostic Prediction for Stroke Patients Using Machine Learning
Scientific Title:Acronym
Prognostic Prediction for Stroke Patients Using Machine Learning
Region
| Japan |
Condition
Condition
Ischemic Stroke and Hemorrhagic Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop and validate a prognostic model to predict discharge Functional Independence Measure , focusing on variables that are observable and compatible with the aging stroke population in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction Accuracy of Functional Independence Measure (FIM) at Discharge
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ischemic or hemorrhagic stroke who were admitted to a convalescent rehabilitation ward for 30 days or more between January 2018 and December 2020.
Key exclusion criteria
Those who experienced recurrence or worsening of their condition during hospitalization
Those who suffered a stroke (cerebral infarction or cerebral hemorrhage) while being hospitalized in another hospital
Those with a history of neurological diseases other than stroke
Those with a history of mental illness or developmental disorders
Those who developed epilepsy or hydrocephalus at the time of stroke onset
Those who experienced a stroke due to Moyamoya disease
Those who required restrictions on rehabilitation in the convalescent rehabilitation ward
Those with a history of blindness
Those who died during hospitalization
Those with missing data
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Matsuda |
Organization
Hokkaido University of Science
Division name
Department of Physical Therapy Faculty of Health Sciences
Zip code
006-8585
Address
15-4-1, Maeda 7-jo, Teine-ku, Sapporo-shi, Hokkaido, Japan
TEL
+81-11-688-7197
matsuda-r@hus.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Matsuda |
Organization
Hokkaido University of Science
Division name
Department of Physical Therapy Faculty of Health Sciences
Zip code
006-8585
Address
15-4-1, Maeda 7-jo, Teine-ku, Sapporo-shi, Hokkaido, Japan
TEL
+81-11-688-7197
Homepage URL
matsuda-r@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Ryo Matsuda
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shinsapporo Neurosurgical Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shinsapporo Neurosurgical Hospital Ethics Committee
Address
6-2-10, Atsubetsu Chuo 1-jo, Atsubetsu-ku, Sapporo-shi, Hokkaido, Japan
Tel
+81-11-891-2500
regalw4910@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
北海道科学大学（北海道）、新さっぽろ脳神経外科病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_26-00008/_article/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_26-00008/_article/-char/ja
Number of participants that the trial has enrolled
304
Results
For the training dataset, the prediction accuracy for the total FIM motor score was coefficient of determination: 0.86. For the test dataset, the values were coefficient of determination: 0.85. Comparable accuracy was achieved for both the training and test datasets.
Results date posted
| 2026 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study subjects were 422 patients with cerebral infarction or cerebral hemorrhage who had been admitted to the convalescent rehabilitation ward of Shin-Sapporo Neurosurgical Hospital for at least one month between January 2018 and March 2020. As the aim of this study was to verify accuracy, the following exclusion criteria were applied to eliminate the influence of atypical cases: history of neurological disorders (e.g., Parkinson's disease, multiple sclerosis); history of psychiatric disorders (e.g., schizophrenia, bipolar disorder); history or complications involving brain tumors; clinical deterioration during hospitalization (e.g., recurrence, pneumonia, worsening heart failure); blindness; onset of stroke during hospitalization at another facility; and presence of missing data. After applying these exclusion criteria, 304 patients remained for analysis.
Participant flow
This is a retrospective study using existing clinical data from patients with cerebral infarction or cerebral hemorrhage who were admitted to the convalescent rehabilitation ward at Shin-Sapporo Neurosurgical Hospital for one month or longer between January 2018 and March 2020. Data were obtained from electronic medical records.
Adverse events
none
Outcome measures
Baseline data collected included gender, age, Body Mass Index at the time of ward admission, pre-admission care-need status, and the duration from onset to ward admission. Regarding the Functional Independence Measure, data were obtained for FIM sub-items at admission, as well as the FIM motor subscale total score, FIM cognitive subscale total score, and total FIM score. The FIM motor subscale total score at discharge was used as the outcome variable.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collected data at admission and discharge from the medical records of patients diagnosed with cerebral infarction or cerebral hemorrhage who were admitted to a convalescent rehabilitation ward for 30 days or more between January 2018 and December 2020.
Management information
Registered date
| 2025 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064809
