UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060236 |
|---|---|
| Receipt number | R000068894 |
| Scientific Title | Effects of Tactile-Based Multisensory Learning on Reading and Writing Skills in Children with Developmental Dyslexia |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/30 12:39:35 |
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Basic information
Public title
The Effects of Tactile Information on Orthographic Processing in Children with Developmental Dyslexia
Acronym
Effects of Tactile-Based Multisensory Learning on Reading and Writing Skills in Children with Developmental Dyslexia
Scientific Title
Effects of Tactile-Based Multisensory Learning on Reading and Writing Skills in Children with Developmental Dyslexia
Scientific Title:Acronym
Effects of Tactile-Based Multisensory Learning on Reading and Writing Skills in Children with Developmental Dyslexia
Region
| Japan |
Condition
Condition
Developmental Dyslexia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether tactile-based letter learning is effective for children with developmental dyslexia and to investigate how it affects their processing of letter information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the primary analysis, we will first administer a letter recognition task as a baseline.
After that, participants will receive tactile recognition training once per day for three consecutive days.
We will evaluate the effect of tactile learning on letter recognition processing by comparing changes in letter recognition performance between groups.
Key secondary outcomes
for each letter recognition task, changes in performance before and after relearning were compared between the two groups to analyze the task-specific effects of tactile learning.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Tactile-learning group.
Children with developmental dyslexia will receive a learning program involving tactile recognition of letters and numerals combined with visual presentation.
The learning sessions will be conducted once per day for three consecutive days (three sessions in total).
Four types of letter-recognition tasks will be administered before and after the intervention to evaluate changes in performance.
Interventions/Control_2
Visual-learning-only group (control).
Children with developmental dyslexia will receive visual learning of letters and numerals without tactile training.
The learning sessions will be conducted once per day for three consecutive days (three sessions in total).
Four types of letter-recognition tasks will be administered before and after the intervention to evaluate changes in performance.
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
Elementary school children aged 6 to 12 years who meet the diagnostic criteria for developmental dyslexia
Key exclusion criteria
Children who have previously participated in letter-learning activities using tactile stimuli as experimental materials were excluded from the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Kyoto University
Division name
Department of Advanced Occupational Therapy, Division of Human Health Sciences, Graduate School of Medicine
Zip code
606-8397
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3966
yoshimura.sayaka.3x@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Kyoto University
Division name
Division of Human Health Sciences, Graduate School of Medicine
Zip code
606-8397
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3966
Homepage URL
yoshimura.sayaka.3x@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Kyoto University Clinical Research Review Committee
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2026 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068894
