UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056587 |
|---|---|
| Receipt number | R000064668 |
| Scientific Title | An Intervention Aimed at Acquiring Traditional Chopstick-Holding Skills: A Preliminary Efficacy Study Using Assistive Chopsticks |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2026/02/18 13:48:51 |
* 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
An Intervention Aimed at Acquiring Traditional Chopstick-Holding Skills: A Preliminary Efficacy Study Using Assistive Chopsticks
Acronym
An Intervention Aimed at Acquiring Traditional Chopstick-Holding Skills: A Preliminary Efficacy Study Using Assistive Chopsticks
Scientific Title
An Intervention Aimed at Acquiring Traditional Chopstick-Holding Skills: A Preliminary Efficacy Study Using Assistive Chopsticks
Scientific Title:Acronym
An Intervention Aimed at Acquiring Traditional Chopstick-Holding Skills: A Preliminary Efficacy Study Using Assistive Chopsticks
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to preliminarily examine whether an intervention using assistive chopsticks enables the acquisition of traditional chopstick-holding skills.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Applications, Visual analysis, Surveys
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Chopstick training using assistive chopsticks. The intervention period is 20 days. The number of measurement times varies among the participating children, with 6-9 measurements during the baseline period and 11-14 measurements during the intervention period. The intervention time coincides with dinner.
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A healthy elementary school student who cannot use chopsticks in the traditional way.
Key exclusion criteria
A child who has difficulty understanding the research.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Choji |
Organization
Niigata University of Rehabilitation
Division name
Occupational Therapy Course, Department of Rehabilitation Faculty of Allied Health Sciences
Zip code
958-0053
Address
2-16, Kaminoyama, Murakami-shi, Niigata-ken, 958-0053, Japan
TEL
0254-56-8292
tyouji@nur.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Choji |
Organization
Niigata University of Rehabilitation
Division name
Occupational Therapy Course, Department of Rehabilitation Faculty of Allied Health Sciences
Zip code
958-0053
Address
2-16, Kaminoyama, Murakami-shi, Niigata-ken, 958-0053, Japan
TEL
0254-56-8292
Homepage URL
tyouji@nur.ac.jp
Sponsor or person
Institute
Niigata University of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Niigata University of Rehabilitation
Address
2-16, Kaminoyama, Murakami-shi, Niigata-ken, 958-0053, Japan
Tel
0254-56-8292
takebe@nur.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 | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064668
