UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058538 |
|---|---|
| Receipt number | R000066937 |
| Scientific Title | Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities: A Crossover Trial |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/21 22:07:29 |
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Basic information
Public title
Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities
Acronym
Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities
Scientific Title
Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities: A Crossover Trial
Scientific Title:Acronym
Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities
Region
| Japan |
Condition
Condition
Developmental Disabilities
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Children with developmental disabilities, including specific learning disorders and autism spectrum disorders, often experience difficulties in academic skills such as handwriting and arithmetic. Even when schools implement tailored educational strategies, some students remain unable to adapt and subsequently become school-refusing; yet evidence supporting pharmacological or psychotherapeutic interventions is scarce.
Brain Gym, a series of exercises developed within the field of pedagogy to stimulate brain activity, has been proposed as a potentially effective intervention for children with learning difficulties, but empirical research on its efficacy is limited. If Brain Gym proves effective, it could enhance school adjustment and, by extension, improve future social integration and quality of life. This study therefore investigates the efficacy of Brain Gym in alleviating handwriting and arithmetic difficulties in children with developmental disabilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on the "Kanji Writing" and "Arithmetic" Tasks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
We requested the participants' elementary school to prepare six task sets tailored to each student's individual learning progress. Each set comprised ten items with a maximum score of ten points, and scoring was performed by the school under blinded conditions.
Participants were randomly assigned to two groups (A and B). A unique random number was generated for each participant in Excel; participants were then sorted in ascending order of these numbers and alternately allocated to groups A and B.
From week 1 through week 6, both groups completed their assigned tasks on Day 1 of each week.
Weeks 1 and 2 constituted Phase I. On Day 1 of week 1, only group A received instruction in the Brain Gym movements (hereafter "the movements") immediately after task completion, and were thereafter encouraged to apply the movements as needed. The five movements taught were PACE, Earth Button, Space Button, Owl, and Calf Pumps. On Day 1 of weeks 2 and 3, group A performed the movements prior to task completion. After the Day 1 session in week 3, group A was instructed to discontinue the movements.
Week 3 served as a washout period. Although U.S. FDA guidelines recommend a washout lasting at least five times the elimination half-life, the half-life for these movements is unknown; accordingly, we provisionally set the washout to one week.
Weeks 4 and 5 constituted Phase II. On Day 1 of week 4, only group B received instruction in the movements immediately after task completion, and were thereafter encouraged to use them as appropriate. On Day 1 of weeks 5 and 6, group B performed the movements prior to task completion. The intervention concluded upon completion of the Day 1 session in week 6.
Interventions/Control_2
Concurrent receipt of conventional inpatient treatment
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
| 9 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- As of July 25, 2025, the patient is admitted to the Child Psychiatry Unit of our hospital.
- The patient is in the 4th or 5th grade of elementary school.
- The principal diagnosis is "F8 Disorders of psychological development (ICD-10)".
Key exclusion criteria
- Inability to perform the prescribed exercises as instructed due to a physical disorder
- Presence of severe aggression, irritability, depressed mood, or markedly reduced motivation, rendering adherence to the exercise protocol infeasible
- Situations in which obtaining informed consent from the family is deemed inappropriate (e.g., cases under active intervention by the Child Consultation Center)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Sakurai |
Organization
National Hospital Organization Tenryu Hospital
Division name
Department of Child and Adolescent Psychiatry
Zip code
434-8511
Address
4201-2 Oro, Hamana Ward, Hamamatsu City, Shizuoka Prefecture 434-8511, Japan
TEL
053-583-3111
asakurai89314@gmail.com
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Sakurai |
Organization
National Hospital Organization Tenryu Hospital
Division name
Department of Child and Adolescent Psychiatry
Zip code
434-8511
Address
4201-2 Oro, Hamana Ward, Hamamatsu City, Shizuoka Prefecture 434-8511, Japan
TEL
053-583-3111
Homepage URL
asakurai89314@gmail.com
Sponsor or person
Institute
National Hospital Organization Tenryu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Tenryu Hospital
Address
4201-2 Oro, Hamana Ward, Hamamatsu City, Shizuoka Prefecture 434-8511, Japan
Tel
053-583-3111
asakurai89314@gmail.com
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 | 07 | Month | 25 | 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
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 29 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066937
