Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058538) titled 'Efficacy of Brain Gym for Writing and Arithmetic Difficulties in Children with Developmental Disabilities' on July 25.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - National Hospital Organization Tenryu Hospital

Condition: Condition - Developmental Disabilities Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 9 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066937

Disclaimer: Curated by HT Syndication.