UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058570 |
|---|---|
| Receipt number | R000066550 |
| Scientific Title | Clinically Useful Cutoff Scores for FIM Motor Severity in Acute Stroke: An Ordinal Regression and ROC Analysis of a Large-Sample Cohort |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/07/23 19:09:05 |
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Basic information
Public title
Clinically Useful Cutoff Scores for FIM Motor Severity in Acute Stroke
Acronym
Cutoff Scores for ADL Severity in Acute Stroke
Scientific Title
Clinically Useful Cutoff Scores for FIM Motor Severity in Acute Stroke: An Ordinal Regression and ROC Analysis of a Large-Sample Cohort
Scientific Title:Acronym
Clinically Useful Cutoff Scores for FIM Motor Severity in Acute Stroke
Region
| Japan |
Condition
Condition
Patients with acute stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify clinical factors associated with the severity of motor FIM scores at discharge among patients with acute stroke.
Basic objectives2
Others
Basic objectives -Others
To derive predictive cutoff values-particularly of NIHSS-that distinguish between severity levels.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure motor score, National Institutes of Health Stroke Scale
Key secondary outcomes
Age, sex, stroke subtype, pre-stroke modified Rankin Scale
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
Patients who had been admitted to the stroke care unit with a diagnosis of either cerebral infarction or cerebral hemorrhage and had received rehabilitation during hospitalization.
Key exclusion criteria
Missing data in FIM at discharge, NIHSS scores at onset, or other variables, and death.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Amano |
Organization
Kitasato University
Division name
Department of Rehabilitation
Zip code
252-0329
Address
1-15-1, Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
042-778-8111
s-amano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Sora |
| Middle name | |
| Last name | Kurosaki |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
kurosaki1124sora@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Sora Kurosaki
Funding Source
Organization
Kitasato University Hospital
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
Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-Ku, Sagamihara, Kanagawa
Tel
042-778-8111
kurosaki1124sora@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To identify predictors of FIM motor severity, an ordinal logistic regression model was constructed with FIM motor severity level (1 = severe, 2 = moderate, 3 = mild) as the dependent variable. Predictor variables included age, pre-stroke mRS, NIHSS at onset, and stroke type (ischemic or hemorrhagic). Odds ratios (ORs), 95% confidence intervals (CIs), and p-values were reported. Model fit was assessed using a likelihood ratio test and McFadden's pseudo-R squared. To evaluate the discriminative performance of the model, ROC curve analyses were performed to assess the ability to distinguish between adjacent severity levels. In addition, nonparametric group comparisons across the three FIM motor severity levels were conducted for continuous variables (age, pre-stroke mRS, and NIHSS) using the Kruskal-Wallis test, followed by Steel-Dwass post hoc tests. Stroke type was compared across severity groups using Pearson's chi-squared test. Finally, for each predictor that was significantly associated with FIM motor severity, ROC curve analysis was performed to derive optimal cutoff values using the Youden index.
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066550
