UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055307 |
|---|---|
| Receipt number | R000063200 |
| Scientific Title | Validation of Inter-Rater Reliability for modified The Tinkertoy Test |
| Date of disclosure of the study information | 2024/08/22 |
| Last modified on | 2024/08/22 11:11:59 |
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Basic information
Public title
Validation of Inter-Rater Reliability for modified The Tinkertoy Test
Acronym
Validation of Inter-Rater Reliability for modified The Tinkertoy Test
Scientific Title
Validation of Inter-Rater Reliability for modified The Tinkertoy Test
Scientific Title:Acronym
Validation of Inter-Rater Reliability for modified The Tinkertoy Test
Region
| Japan |
Condition
Condition
Healthy Individuals and Patients with Schizophrenia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the inter-rater reliability of modified The Tinkertoy Test.
Basic objectives2
Others
Basic objectives -Others
To elucidate the differences in scoring tendencies on modified The Tinkertoy Test between healthy individuals and patients with schizophrenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scoring Based on the Evaluation Criteria of modified The Tinkertoy Test
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
For scoring modified The Tinkertoy Test, occupational therapists with over 10 years of experience were selected. The 20 healthy individuals in the scoring videos were male and female participants aged 20 to 65 who had given their consent to participate in the study. The 20 patients with schizophrenia met the diagnostic criteria and were also male and female participants aged 20 to 65 who had given their consent to participate in the study.
Key exclusion criteria
The exclusion criteria for occupational therapists performing the scoring were those with less than 10 years of experience. The exclusion criteria for participants in the video recordings were individuals under the age of 20.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
4750012
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
TEL
0569200131
n-yasu@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
4750012
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
TEL
0569200131
Homepage URL
n-yasu@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
yasuhisa nakamura
Funding Source
Organization
Kagaku Kenkyuhi
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon Fukushi University Ethics Committee
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
Tel
0569200131
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 22 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two occupational therapists will score the videos of 20 healthy individuals and 20 patients with schizophrenia using modified The Tinkertoy Test. The results will be validated using the intraclass correlation coefficient and Bland-Altman analysis.
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063200
