UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062388 |
|---|---|
| Receipt number | R000071396 |
| Scientific Title | Development of a Prognostic Indicator for Stroke Outcomes Using Computed Tomography-Derived Corticospinal Tract Lesion Volume |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/07/29 17:00:48 |
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Basic information
Public title
Development of a CT-Based Prognostic Indicator for Stroke Outcomes
Acronym
CT-Based Stroke Prognosis Study
Scientific Title
Development of a Prognostic Indicator for Stroke Outcomes Using Computed Tomography-Derived Corticospinal Tract Lesion Volume
Scientific Title:Acronym
CT-CST Stroke Prognosis Study
Region
| Japan |
Condition
Condition
Putaminal or thalamic hemorrhage
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the reliability of CT-derived corticospinal tract lesion volume and to develop an algorithm for predicting motor function outcomes using this measure.
Basic objectives2
Others
Basic objectives -Others
To evaluate the reliability of CT-derived corticospinal tract lesion volume and develop a motor function outcome prediction algorithm using this measure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function at discharge from the convalescent rehabilitation ward. Motor function will be assessed using the Brunnstrom Recovery Stage for the upper extremity, hand, and lower extremity.
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
1. Patients admitted to and discharged from the convalescent rehabilitation ward of Koshu Rehabilitation Hospital between April 2016 and December 2025
2. Patients diagnosed with putaminal or thalamic hemorrhage
3. Patients with head CT images obtained within 48 hours after stroke onset
4. Patients with available clinical data on motor function and activities of daily living at admission and discharge
Key exclusion criteria
1. Patients with recurrent stroke
2. Patients with a pre-existing neurological disorder
3. Patients with a pre-existing psychiatric disorder
4. Patients who were not independent in activities of daily living before stroke onset
5. Patients without available head CT images obtained during acute hospitalization
6. Patients with missing clinical data required for image analysis or outcome assessment
7. Patients who declined participation in the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, JAPAN
TEL
029-888-4000
yamamotos@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, JAPAN
TEL
029-888-4000
Homepage URL
44250047@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
no
Address
no
Tel
no
no
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 | 09 | Month | 01 | 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
100
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
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using existing clinical data and head CT images of patients with putaminal or thalamic hemorrhage who were admitted to the convalescent rehabilitation ward of Koshu Rehabilitation Hospital.
Consecutive patients admitted to the ward from April 2016 onward and discharged by December 2025 will be screened. Patients who meet the eligibility criteria and do not meet any of the exclusion criteria will be included.
The intra-rater and inter-rater reliability of CT-derived corticospinal tract lesion volume will be evaluated. The associations of corticospinal tract lesion volume and clinical variables, including age, time from stroke onset to admission to the convalescent rehabilitation ward, motor function at admission, and activities of daily living at admission, with motor function at discharge will also be examined. A motor function outcome prediction algorithm will subsequently be developed using decision tree analysis.
No additional examinations, treatments, or other interventions will be performed for the study participants.
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071396
