UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061599 |
|---|---|
| Receipt number | R000070479 |
| Scientific Title | Development of an FIM Prediction Model for Stroke Patients in Convalescent Rehabilitation Wards Considering the Impact of Aging |
| Date of disclosure of the study information | 2026/05/31 |
| Last modified on | 2026/05/17 06:11:25 |
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Basic information
Public title
Development of an AI Model to Predict Functional Recovery after Stroke Rehabilitation
Acronym
stroke AI-based Rehabilitation prognosis prediction with Advanced Interpretability
Scientific Title
Development of an FIM Prediction Model for Stroke Patients in Convalescent Rehabilitation Wards Considering the Impact of Aging
Scientific Title:Acronym
Aging-aware Gradient Estimation of FIM in stroke rehabilitation
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Random Forest model predicting discharge FIM scores in stroke patients in convalescent rehabilitation wards, incorporating aging-related variables, and to evaluate its predictive accuracy and clinical interpretability using SHAP analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discharge motor FIM total score
Key secondary outcomes
- Discharge total FIM score - Discharge cognitive FIM total score- Individual FIM sub-item scores- Model performance - Variable contribution via SHAP values- Age-stratified model performance
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 admitted to the convalescent rehabilitation ward at Shin-Sapporo Neurosurgical Hospital between January 2018 and March 2020
Patients with a primary diagnosis of cerebral infarction or intracerebral hemorrhage
Patients with a length of stay in the convalescent rehabilitation ward of at least one month
Key exclusion criteria
Patients with a history of neurological diseases (e.g., Parkinson's disease, multiple sclerosis)
Patients with a history of psychiatric disorders (e.g., schizophrenia, bipolar disorder)
Patients with a history or complication of brain tumor
Patients who experienced clinical deterioration during hospitalization (e.g., stroke recurrence, pneumonia, exacerbation of heart failure)
Patients with blindness
Patients who developed stroke during hospitalization at another medical facility
Patients 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
0068585
Address
4-1, 15-chome, Maeda 7-jo, Teine-ku, Sapporo, Hokkaido 006-8585, Japan
TEL
0116887197
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
0068585
Address
4-1, 15-chome, Maeda 7-jo, Teine-ku, Sapporo, Hokkaido 006-8585, Japan
TEL
0116887197
Homepage URL
matsuda-r@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Ryo Matsuda
Funding Source
Organization
Hokkaido University of Science
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
Department of Rehabilitation, Neuroscience Research Center Shin Sapporo Neurosurgical Hospital
Address
2-10, 6-chome, Atsubetsu-chuo 1-jo, Atsubetsu-ku, Sapporo, Hokkaido 004-0051, Japan
Tel
0118912500
pt@snh.or.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
| 2026 | Year | 05 | Month | 31 | 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
304
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
| 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
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was approved by the Ethics Committee of the Graduate School of Health Sciences, Hirosaki University (approval number: 2025-008, approval date: August 18 , 2025) and the Institutional Review Board of Shin-Sapporo Neurosurgical Hospital (approval date: March 7, 2022) as a retrospective observational study using existing clinical data. Individual informed consent was waived, and study information is disclosed on the hospital's notice board and website (opt-out approach). All data will be anonymized prior to analysis.
Management information
Registered date
| 2026 | Year | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070479
