UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048587 |
|---|---|
| Receipt number | R000055363 |
| Scientific Title | Validation of the assessment of executive function and physical characteristics according to executive function in patients with stroke |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2023/08/12 16:51:50 |
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Basic information
Public title
Validation of the assessment of executive function and physical characteristics according to executive function in patients with stroke
Acronym
Validation of the assessment of executive function and physical characteristics according to executive function in patients with stroke
Scientific Title
Validation of the assessment of executive function and physical characteristics according to executive function in patients with stroke
Scientific Title:Acronym
Validation of the assessment of executive function and physical characteristics according to executive function in patients with stroke
Region
| Japan |
Condition
Condition
Patients with storke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to verify the validity and reliability of the Japanese version of the executive function assessment and to investigate the relationship between executive dysfunction and physical function in patients with stroke.
Basic objectives2
Others
Basic objectives -Others
The aim of the study is to verify the validity and reliability of the Japanese version of the executive function assessment and to investigate the relationship between executive dysfunction and physical function in patients with stroke.
The validity and reliability of the executive function assessment is verified by the Frontal Assessment Battery and the Stroop test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frontal Assessment Battery
Key secondary outcomes
Stroop test
Timed up and go test
Brunnstrom Recovery Stage
Berg Balance 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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with first stroke hemiplegia
Patients who are able to administer the Frontal Assessment Battery, Mini-Mental State Examination and Stroop Test
Key exclusion criteria
Patients who have difficulty performing the task due to higher brain dysfunction, cognitive symptoms or a history of orthopaedic disease.
Target sample size
100
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
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
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawajima Memorial Hospital
Address
2-5-2, Tsukuda, Chuo-ku, Tokyo
Tel
03-3532-3201
ptkmorikawa@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
石川島記念病院（東京都）、令和リハビリテーション病院（千葉県）, 森山脳神経センター病院（東京）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | 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
Observational study
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055363
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| Registered date | File name |
| Research case data | |
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