UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053898 |
|---|---|
| Receipt number | R000061526 |
| Scientific Title | Influence of the device of underlining on the movement of the brushstroke. |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/23 14:59:58 |
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Basic information
Public title
Influence of the device of underlining on the movement of the brushstroke.
Acronym
Influence of the device of underlining on the movement of the brushstroke.
Scientific Title
Influence of the device of underlining on the movement of the brushstroke.
Scientific Title:Acronym
Influence of the device of underlining on the movement of the brushstroke.
Region
| Japan |
Condition
Condition
Elementary school student
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effect of using dotted underlays for handwriting control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We use TraceCoder to trace shapes before and after the task, and calculate the area of trace misalignment, writing pressure and measurement time. For analysis, we calculate the "amount of change in writing pressure with/without underlining" and "change in displacement area per unit time with/without underlining" and compare the difference. Additionally, we examine the participants' motor coordination, sensory characteristics, and eye
movements, dividing them into the complex and standard groups and comparing the two groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
Work on the writing task for 5 minutes without using the dotted underlays. We use TraceCoder to trace shapes before and after the task, and calculate the area of trace misalignment, writing pressure and measurement time.
Interventions/Control_2
Using the dotted underlays, students work on the writing task for 5 minutes. We use TraceCoder to trace eight different shapes before and after the task, and calculate the area of trace misalignment, writing pressure and measurement time.
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
They are able to write Hiragana. They are physically and mentally healthy. They are told by teachers, parents, or the person that they are not good at handwriting.
Key exclusion criteria
They have used "Sensei osusume mahouno zarazara shitajiki" or sandpaper as a underlay.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Muramatsu |
Organization
Tokyo metropolitan university
Division name
Master's course Department of occupational therapy, graduate school of human health sciences.
Zip code
3300072
Address
4-8-5, Ryouke, Urawa-ku, Saitama-shi, Saitama, Japan
TEL
09066544550
sea09042345@gmail.com
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Muramatsu |
Organization
Tokyo metropolitan university
Division name
Master's course Department of occupational therapy, graduate school of human health sciences.
Zip code
3300072
Address
4-8-5, Ryouke, Urawa-ku, Saitama-shi, Saitama, Japan
TEL
09066544550
Homepage URL
sea09042345@gmail.com
Sponsor or person
Institute
Tokyo metropolitan university
Institute
Department
Personal name
Natsumi Muramatsu
Funding Source
Organization
No
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
Tokyo metropolitan university
Address
7-2-10, higashioku, Arakawa-ku, Toukyo, Japan
Tel
0338191211
a-rinri@jmj.tmu.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 | 03 | Month | 19 | 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
33
Results
They found significant differences appeared in the "change in displacement area per unit time with/without underlining" for straight lines and triangles.
Results date posted
| 2024 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Although they are able to write hiragana, they show difficulty with handwriting, such as weak writing pressure and sloppy handwriting.
Participant flow
Adverse events
Outcome measures
We used TraceCoder to trace eight different shapes before and after the task, and calculated the area of trace misalignment, writing pressure and measurement time. For analysis, we calculated the "amount of change in writing pressure with/without underlining" and "change in displacement area per unit time with/without underlining" and compared the difference. Additionally, we examined the participants' motor coordination, sensory characteristics, and eye
movements, dividing them into the complex and standard groups and comparing the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061526
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