UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051231 |
|---|---|
| Receipt number | R000058413 |
| Scientific Title | Reliability Study of Remote Cognitive Assessment (MoCA-J) in Patients with Stroke. |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/01 19:01:43 |
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Basic information
Public title
Reliability Study of Remote Cognitive Assessment (MoCA-J) in Patients with Stroke.
Acronym
Reliability of Remote MoCA-J in Stroke.
Scientific Title
Reliability Study of Remote Cognitive Assessment (MoCA-J) in Patients with Stroke.
Scientific Title:Acronym
Reliability of Remote MoCA-J in Stroke.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reliability of remote MoCA-J in patients with stroke.
Basic objectives2
Others
Basic objectives -Others
Reliability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Montreal Cognitive Assessment-Japanese (MoCA-J)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic stroke patients (> 90 days from stroke onset).
Key exclusion criteria
1. those who have difficulty communicating due to aphasia or unconsciousness.
2. those who have difficulty performing assessments due to severe higher brain dysfunction.
3. those who have difficulty holding a sitting position for more than 10 minutes.
4. those who have difficulty in performing mechanical tests due to hemiplegia, bone fracture, or reduced dexterity.
5. those with severe visual or hearing impairment.
6. those with severe comorbidities such as heart disease or malignant tumors.
7. Persons with severe psychiatric disorders such as depression and schizophrenia.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University.
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
taisho8036@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Eisai Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2023 | Year | 06 | 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
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Montreal Cognitive Assessment-Japanese (MoCA-J) will be conducted twice in total. Each inspection is 10 to 15 minutes, so the total time is less than 30 minutes. The sequence of the two inspections is determined at random, one in person and the other by video. The period between the two inspections should be at least 2 weeks and less than 3 months.
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058413
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
