UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050505 |
|---|---|
| Receipt number | R000057298 |
| Scientific Title | Intervention efficacy of eye-hand training using training application for developmental disorders: pre- and post-training clinical trial in fluency and legibility of writing |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/04/09 17:36:21 |
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Basic information
Public title
Intervention efficacy of eye-hand training using training application for developmental disorders
Acronym
Intervention efficacy of eye-hand training using training application
Scientific Title
Intervention efficacy of eye-hand training using training application for developmental disorders: pre- and post-training clinical trial in fluency and legibility of writing
Scientific Title:Acronym
Intervention efficacy of eye-hand training using training application
Region
| Japan |
Condition
Condition
Neuro-developmental disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study investigates efficacy of eye-hand coordination intervention program using tablet PC and stylus pen for elementary school children with developmental disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WAVES (Wide-range Assessment of Vison-related Essential Skills)
URAWSS 2(Understanding Reading and Writing Skills of Schoolchildren 2)
Far and near number copying test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects received an intervention training program, eye-hand coordination training, for the first 4 weeks. After a first 4-week experimental period, the subjects received a placebo training program for another 4-week experimental period.
Interventions/Control_2
Subjects received a placebo training program for the first 4 weeks. After a first 4-week experimental period, the subjects received an intervention training program, eye-hand coordination training, for another 4-week experimental period.
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
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elementary school children whose standard score of WAVES ECGI or ECAI is less than -1 SD and writing speed of URAWSS 2 is also less than -1 SD is included for the study
Key exclusion criteria
Children with near or far binocular visual acuity less than 20/20, psychiatric problems, or other health-related problems were excluded from the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohito |
| Middle name | |
| Last name | Okumura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Child Higher Brain Function Research Institute
Zip code
569-8686
Address
2-7 Daigaku-machi Takatsuki-shi
TEL
072-684-6236
tomohito.okumura@ompu.ac.jp
Public contact
Name of contact person
| 1st name | tomohito |
| Middle name | |
| Last name | okumura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Child Higher Brain Function Research Institute
Zip code
569-8686
Address
Takatsukishi Daigakuchou 2-7
TEL
072-684-6236
Homepage URL
tomohito.okumura@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University ethics committee
Address
2-7 Daigaku-machi Takatsuki-shi
Tel
072-683-1221
rinri@ompu.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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
