UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060857 |
|---|---|
| Receipt number | R000069636 |
| Scientific Title | The Effect of Weaving Task Regularity on Subsequent Work Time: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 21:00:10 |
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Basic information
Public title
The Effect of Weaving Task Regularity on Subsequent Work Time: A Randomized Controlled Trial
Acronym
Time required for weaving task
Scientific Title
The Effect of Weaving Task Regularity on Subsequent Work Time: A Randomized Controlled Trial
Scientific Title:Acronym
Time required for weaving task
Region
| Japan |
Condition
Condition
able-bodied person,person with a mental disability
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effects of regular and irregular weaving tasks on subsequent work time. Specifically, the aim is to scientifically verify the cognitive and psychological effects of weaving by measuring concentration, mental stability, and the effects of repetitive movements during work.
Through this, we aim to objectively demonstrate the effectiveness of weaving in occupational therapy and create a foundation for future clinical applications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required for weaving work (seconds): Examine the influence of regular and irregular weaving tasks on later work time
Key secondary outcomes
Counting the number of correct errors during weaving work, observing visual movements during weaving tasks, and measuring data from UBOM/D-CAT (Digit Cancellation Test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In this study, in order to examine the effects of regular tasks and irregular tasks in weaving work on subsequent work time, 40 research participants will be randomly divided into two groups: pattern A group and pattern B group.
Interventions/Control_2
When weaving, the time required, number of correct errors, and visual movements are checked. The weaving task consists of 32 sessions x 3 sessions in total (96 sessions in total), and a ``yarn exchange task'' is inserted between each session to reset the condition.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.People with no experience in weaving, 2.Right-handed people, 3.People who received sufficient explanation regarding participation in this study and gave voluntary written consent.
Key exclusion criteria
1. Diseases for which intervention poses a serious risk (unstable angina, recent myocardial infarction, severe arrhythmia, etc.).
2. When a change in condition is expected in a short period of time, such as an active serious infection or a malignant tumor undergoing treatment.
3. Difficult to obtain consent or cooperate in evaluation due to severe cognitive impairment or psychiatric symptoms (MMSE < 18, MoCA < 18, etc. Thresholds are set in the study).
4. Cases in which procedural explanation or evaluation is impossible due to severe aphasia or hearing impairment (do not rule out alternative methods if available).
5.In addition, if the attending physician determines that participation in the study is inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Horita |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
0476207779
horitah@ihwg.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Horita |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
0476207779
Homepage URL
horitah@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City, Chiba
Tel
0476-20-7701
horitah@ihwg.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
| 2026 | Year | 03 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069636
