UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055578 |
|---|---|
| Receipt number | R000063459 |
| Scientific Title | Handwriting training with a board prototype: A randomized controlled trial |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/09/21 19:05:22 |
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Basic information
Public title
The effect of handwriting practice using a new handwriting training board
Acronym
Handwriting training of training board
Scientific Title
Handwriting training with a board prototype: A randomized controlled trial
Scientific Title:Acronym
Training with a board prototype
Region
| Japan |
Condition
Condition
Patients with hemiplegia
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated whether handwritten characters differ between line tracing on a handwriting trainingboard developed by the authors and line tracing training on a paper.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1.Character shapes The intervention is effective if the number of characters read after the intervention is greater than the number of characters read before the intervention in OCR analysis.
2.It is valid if the average number of fixations is lower after the intervention than before the intervention.
3.If the average writing pressure is stronger after the intervention than before, it is considered effective.
4.Changes in writing pressure per unit of time are valid if they are smaller than those at the time of intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions:Practice handwriting with participants left hand using a practice board for 10 minutes a day for two weeks.
Interventions/Control_2
Control:Practice handwriting with participants left hand using a training paper for 10 minutes a day for two weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 21 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.right-handed
2 had good eyesight
3.had the time to continually perform the same exercises every day for 2 weeks.
Key exclusion criteria
1.History of major eye disease
2.History of brain disease
3.Who had handwriting training with their nondominant hand at least once in the past.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Suzuki |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
9902212
Address
260 kamiyanagi,Yamagata-shi,Yamagata Japan
TEL
023-686-6652
yusuzuki@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Suzuki |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
9902212
Address
260 kamiyanagi,Yamagata-shi,Yamagata Japan
TEL
0238686652
Homepage URL
yusuzuki@yachts.ac.jp
Sponsor or person
Institute
Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION OF SIENCE
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
Yamagata Prefectural University of Health Sciences
Address
Yamagata Prefectural University of Health Sciences
Tel
023-686-6652
yusuzuki@yachts.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 | 03 | Month | 31 | 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
64
Results
1.Carved line board training did not increase the number of visual fixations.
2.Compared with paper training, carved line board training improved character shapes.
3.Carved line board training also increased writing pressure.
4.Carved line board training can be used for writing training in patients with hemiplegia changing handedness.
Results date posted
| 2024 | Year | 09 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The data analysis after the trial was completed was complex and voluminous, so it took a long time to analyze and consolidate it.
Date of the first journal publication of results
Baseline Characteristics
All Participants(male:female) 64(8:56)
Age(year) 21.5+-0.7
Total time(msec) 1457+-511
Character shapes(Count) 46+-11
Average number of fixation(time) 3.8+-1.3
Average writing pressure(g) 54.3+-18.5
Changes in writing pressure per unit of time(g/msec) 0.6+-0.4
Control Participants(male:female) 32(4:28)
Age(year) 21.2+-0.8
Total time(msec) 1382+-405
Character shapes(Count) 46+-11
Average number of fixation(time) 3.8+-1.3
Average writing pressure(g) 47.3+-25.5
Changes in writing pressure per unit of tim(g/msec) 0.6+-0.3
Intervention Participants (male:female) 32(4:28)
Age(year) 21.5+-0.6
Total time(msec) 1621+-531
Character shapes(Count) 44+-10
Average number of fixation(time) 4.0+-1.4
Average writing pressure(g) 52.4+-20.8
Changes in writing pressure per unit of time(g/msec) 0.5+-0.3
Participant flow
1.Grouping Control(Parper Traning) 32 Intervention (Board Traning) 32
2.Pre training assessment Control(Parper Traning) 32 Intervention (Board Traning) 32
3.Intervention Control(Parper Traning) 32 Intervention (Board Traning) 32
4.Post training assessment Control(Parper Traning) 30 Intervention (Board Traning) 32
Adverse events
Two participants in the control group dropped out due to missing two days of training.
Outcome measures
1.Character shapes(Count) Pretraining assessment :Control 42 Intervention 46, Posttraining assessment:Control 44 Intervention 51
Multiple comparisons Pretraining assessment Control:Posttraining assessment Intervation p=0.020 95% Confidence interval -16.5499--0.9501
Pretraining assessment Intervation:Posttraining assessment Intervation p=0.038 95% Confidence interval 0.2766-14.2234
2.Average number of fixation(time) Pretraining assessment :Control 4.0+-1.5 Intervation 4.0+-1.4, Posttraining assessment:Control 3.5+-1.3
Intervation 3.8+-1.5
Multiple comparisons Preraining assessment Control:Posttraining assessment Control p=0.009 95% Confidence interval 0.2766-14.2234
3.Average writing pressure(g) Pretraining assessment:Control 561.0+-134.7 Intervation 522+-208.0,
Posttraining assessment:Control 620+-240.5 Intervation 607.8+-296.2
Multiple comparisons Posttraining assessment Control:Pretraining assessment Intervation p=0.002 95% Confidence interval -169.2345--27.1671
Pretraining assessment Control:Posttraining assessment Control p=0.010 95% Confidence interval 15.1446-155.2135
4.Changes in writing pressure per unit of time(g/msec) Pretraining assessment:Control 0.63+-0.34 Intervation 0.73+-0.39
Pretraining assessment Control 0.47+-0.29 Intervation 0.56+-0.27
Multiple comparisons Pretraining assessment Control:Posttraining assessment Control,p=0.036 95% Confidence interval -0.1987--0.0046
Pretraining assessment Control:Pretraining assessment Intervation,p=0.000 95%Confidence interval 0.0589-0.2537
Posttraining assessment control,Posttraining assessment Control:p=0.000 95%Confidence interval 0.1598-0.3561
Posttraining assessment control,Posttraining assessment Intervation:p=0.000 95%Confidence interval 0.0697-0.2626
Plan to share IPD
No
IPD sharing Plan description
No
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 20 | 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 | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063459
