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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031879
Receipt No. R000036312
Scientific Title Verification of reliability and validity of modified The Tinkertoy Test
Date of disclosure of the study information 2018/03/24
Last modified on 2019/10/02

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Basic information
Public title Verification of reliability and validity of modified The Tinkertoy Test
Acronym Verification of reliability and validity of modified The Tinkertoy Test
Scientific Title Verification of reliability and validity of modified The Tinkertoy Test
Scientific Title:Acronym Verification of reliability and validity of modified The Tinkertoy Test
Region
Japan

Condition
Condition Schizophrenia & Healty Person
Classification by specialty
Psychiatry Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Reliability and validity of Modified The Tinkertoy Test in Schizophrenia patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Modified The Tinkertoy Test
Key secondary outcomes Design Fluency Test,Idea Fluency Test, Japanese Adult Reading Test,Positive and Negative Syndrome Scale,Global assessment of Functioning,Flow Question Paper,Life Skills Plofile

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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1.20 to 60 years old
2. Outpatients diagnosed with Schizophrenia
Key exclusion criteria 1.Intellectual Disability,Developmental disorders
2.Alcoholism,Drug addiction
3.Organic psychosis
Target sample size 106

Research contact person
Name of lead principal investigator
1st name Yasuhisa
Middle name
Last name Nakamura
Organization Nihon Fukushi University Faculty of Health Science
Division name Occupational Therapy Department
Zip code 475-0012
Address 26-2,Higashihaemi-cho,Handa-city,Aichi-pref
TEL 0569-20-0131
Email n-yasu@n-fukushi.ac.jp

Public contact
Name of contact person
1st name Yasuhisa
Middle name
Last name Nakamura
Organization Nihon Fukushi University Faculty of Health Science
Division name Occupational Therapy Department
Zip code 475-0012
Address 26-2,Higashihaemi-cho,Handa-city,Aichi-pref
TEL 0569-20-0131
Homepage URL
Email n-yasu@n-fukushi.ac.jp

Sponsor
Institute Nihon Fukushi University Faculty of Health Science
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon Fukushi University
Address 26-2,Higashihaemi-cho,Handa-city,Aichi-pref
Tel 0569-20-0131
Email n-yasu@n-fukushi.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 共和病院(愛知県)、こころのクリニック西尾(愛知県)、刈谷病院(愛知県)、桶狭間病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 05 Month 02 Day
Date of IRB
2016 Year 05 Month 15 Day
Anticipated trial start date
2016 Year 05 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigate the relationship between the Reliability, Execution Function and Divergent Indicator of Modified The Tinkertoy Test.

BACS, Design Fluency Test, Idea Fluency Test is used as a clinical indicator of performance function / divergent thinking.

Management information
Registered date
2018 Year 03 Month 24 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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