UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059296 |
|---|---|
| Receipt number | R000067830 |
| Scientific Title | The Effects of Delayed Feedback on Task Performance and Cerebral Hemodynamics During a Handicraft Activity |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 11:00:14 |
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Basic information
Public title
The Effects of Delayed Feedback on Task Performance and Cerebral Hemodynamics During a Handicraft Activity
Acronym
The Effects of Delayed Feedback on Task Performance and Cerebral Hemodynamics During a Handicraft Activity
Scientific Title
The Effects of Delayed Feedback on Task Performance and Cerebral Hemodynamics During a Handicraft Activity
Scientific Title:Acronym
The Effects of Delayed Feedback on Task Performance and Cerebral Hemodynamics During a Handicraft Activity
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the experimental group (with delayed feedback) will be evaluated in comparison to the control group (without delayed feedback) based on task performance and cerebral hemodynamics during the handicraft activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Number of Square Knots in the Macrame Handicraft Task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Delaying Feedback
Interventions/Control_2
Not Delaying Feedback
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older who are able to provide consent, have no motor paralysis or impairment in the hands and can perform macrame tasks, and have no prior experience with macrame activities
Key exclusion criteria
Individuals with motor paralysis or other impairments of the hand that make macrame tasks difficult
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
02632404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Akira Sagari
Funding Source
Organization
Shinshu 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
Shinshu University School of Medicine Ethics Review Board
Address
3-1-1,Asahi,Matsumoto
Tel
0263-37-3099
mdrinri@shinshu-u.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
| 2025 | Year | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067830
