UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060660 |
|---|---|
| Receipt number | R000069371 |
| Scientific Title | Prediction of Discharge Functional Independence Measure (FIM) Scores in Stroke Patients in a Convalescent Rehabilitation Ward: Association Between Multidisciplinary Conference-Based Predictions and an Existing Formula-Based Prediction Model |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/13 08:54:51 |
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Basic information
Public title
Prediction of Discharge Functional Independence Measure (FIM) Scores in Stroke Patients in a Convalescent Rehabilitation Ward: Association Between Multidisciplinary Conference-Based Predictions and an Existing Formula-Based Prediction Model
Acronym
Prediction of Discharge FIM Scores in Stroke Patients in a Convalescent Rehabilitation Ward: Association Between Multidisciplinary Conference-Based Predictions and an Existing Formula-Based Prediction Model
Scientific Title
Prediction of Discharge Functional Independence Measure (FIM) Scores in Stroke Patients in a Convalescent Rehabilitation Ward: Association Between Multidisciplinary Conference-Based Predictions and an Existing Formula-Based Prediction Model
Scientific Title:Acronym
Prediction of Discharge FIM Scores in Stroke Patients in a Convalescent Rehabilitation Ward: Association Between Multidisciplinary Conference-Based Predictions and an Existing Formula-Based Prediction Model
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare discharge Functional Independence Measure (FIM) predictions for stroke patients in a convalescent rehabilitation ward between (1) multidisciplinary conference-based predictions and (2) an existing formula-based prediction model, and to identify patient subgroups in which conference-based predictions demonstrate superiority.
Basic objectives2
Others
Basic objectives -Others
To explore factors associated with the multidisciplinary conference-based predicted discharge FIM values, beyond overall predictive accuracy, in order to clarify determinants of clinically derived predictions.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MAE of discharge mFIM prediction(conference vs formula)
Key secondary outcomes
RMSE,Prediction bias (predicted minus observed),R2,Concordance correlation coefficient (CCC),Calibration intercept and slope,Bland-Altman limits of agreement (LoA),Proportion within error (plus/minus 5/10/15 points),Subgroup performance by admission mFIM severity,Decision curve analysis (net benefit),Determinants of prediction correction (conference minus formula)
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
The participants will be stroke patients admitted to the convalescent rehabilitation ward of Morinomiya Hospital between March 2023 and May 2025.
Key exclusion criteria
Recurrent cases and patients who experienced clinical deterioration during hospitalization and were transferred to another ward or hospital, or who died, were excluded. In addition, because the existing formula-based model used as a comparator in this study was developed primarily for patients with cerebral infarction and intracerebral hemorrhage, cases of subarachnoid hemorrhage were also excluded from the analysis to ensure a fair comparison and a homogeneous study population. Cases with missing data were likewise excluded.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research institute
Zip code
536-0025
Address
2-1-88 Morinomiya,Jyoto-ku,Osaka,Japan.
TEL
06-6969-0111
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Jino |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research institute
Zip code
536-0025
Address
2-1-88 Morinomiya,Jyoto-ku,Osaka,Japan.
TEL
06-6969-0111
Homepage URL
jino@omichikai.or.jp
Sponsor or person
Institute
Omichi-kai Social Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB
Address
2-1-88 Morinomiya,Jyoto-ku,Osaka,Japan.
Tel
06-6969-0111
nrri-jimu@omichikai.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 | 02 | Month | 12 | 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
851
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
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a single-center retrospective observational study of stroke patients admitted to the convalescent rehabilitation ward at Morinomiya Hospital between March 2023 and May 2025. We will compare the observed discharge motor FIM (mFIM) with three within-patient predictions: (1) a multidisciplinary conference-based prediction derived from information available up to hospital day 3, (2) a prediction from an existing formula-based model, and (3) an in-hospital linear regression model estimated from our cohort using the same four predictors (the Morinomiya model). The primary performance metric is mean absolute error (MAE); secondary metrics include RMSE, median absolute error (MedAE), R2, bias (predicted minus observed), the proportion of predictions within 10 points, and agreement analyses such as Bland-Altman plots. The in-hospital regression model will be evaluated using 10-fold cross-validation to estimate generalizability. The existing formula model will be externally validated in our cohort and recalibrated (observed = a + b * pred). Between-model differences will be quantified using paired bootstrap 95% confidence intervals, and p-values will be estimated using permutation tests. In addition, we will examine factors influencing the adjustment by fitting multivariable linear regression with the adjustment term (conference prediction minus formula-model prediction) as the dependent variable, to assess the impact of clinical and social or background factors. Subgroup analyses will be conducted according to admission mFIM severity: mild (mFIM >= 65), moderate (mFIM 39-64), and severe (mFIM <= 38). Clinical utility will be evaluated using decision curve analysis, with discharge mFIM < 70 as the primary event definition.
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069371
