UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061212 |
|---|---|
| Receipt number | R000070041 |
| Scientific Title | Validation of the Reliability and Validity of the Oxford Cognitive Screening-Plus for Patients with Brain Injury |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/09 11:32:01 |
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Basic information
Public title
Validation of the Reliability and Validity of the Oxford Cognitive Screening-Plus for Patients with Brain Injury
Acronym
Validation of the Reliability and Validity of the Oxford Cognitive Screening-Plus for Patients with Brain Injury
Scientific Title
Validation of the Reliability and Validity of the Oxford Cognitive Screening-Plus for Patients with Brain Injury
Scientific Title:Acronym
Validation of the Reliability and Validity of the OCS-Plus for Patients with Brain Injury
Region
| Japan |
Condition
Condition
Patients with Brain injury
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the reliability and validity of the OCS-Plus in patients with brain injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OCS-Plus
Measure twice in five days
Key secondary outcomes
OCS
MMSE
MoCA
FAB
TMT
BADS
WAIS
Memory Scale
Miyake Memory Test
Verbal Fluency Test
Ravens Colored Matrices Test
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a first-time brain injury
Patients capable of maintaining a seated position for 15 minutes or longer
Aged 18 to 89
Patients diagnosed with a brain injury by a physician based on CT or MRI results
Key exclusion criteria
Individuals diagnosed with dementia
Individuals diagnosed with apraxia
Individuals diagnosed with severe aphasia
Individuals diagnosed with severe hemispatial neglect
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
k.sakai@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
k.sakai@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Rehabilitation Hospital
Fukuoka Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metopolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
k.sakai@tmu.ac.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 | 04 | Month | 10 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070041
