UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048587
Receipt No. 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 2022/08/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Chiba Prefectural University of Health Sciences
Division name Faculty of Healthcare Sciences
Zip code 260-0801
Address 645-1, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan 260-0801
TEL 043-305-2164
Email katsuya.sakai_56@cpuhs.ac.jp

Public contact
Name of contact person
1st name Katsuya
Middle name
Last name Sakai
Organization Chiba Prefectural University of Health Sciences
Division name Faculty of Healthcare Sciences
Zip code 260-0801
Address 645-1, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan 260-0801
TEL 043-305-2164
Homepage URL
Email katsuya.sakai_56@cpuhs.ac.jp

Sponsor
Institute Chiba Prefectural University of Health Sciences
Institute
Department

Funding Source
Organization Chiba Prefectural University of Health Sciences
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
Email 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)

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 Preinitiation
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
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.