Clinical Trial: A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes (Japan)

Tokyo, Dec. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059710) titled 'A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes' on Dec. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - self funding

Condition: Condition - Pre- Post Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine gender differences in response to perceptual-motor training on postural control and social interaction in children with autism spectrum disorder (ASD) through a randomized controlled trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 6-week perceptual-motor training program Interventions/Control_2 - Control

Eligibility: Age-lower limit - 7 years-old = Gender - Male and Female Key inclusion criteria - Age between 7 and 13 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria and GARS-2 scale scoring at Level 2 or Level 3 (requiring substantial or very substantial support). Both genders (male and female). No concurrent neurological disorders (e.g., epilepsy, cerebral palsy, or genetic syndromes associated with motor impairment). Ability to participate in simple motor activities without requiring full physical assistance or supportive devices (independent ambulation and basic gross motor skills intact). No use of medications affecting balance, motor control, or social interaction (e.g., antipsychotics, stimulants, anticonvulsants, or benzodiazepines) in the past 3 months. Informed consent and written assent obtained from parents/legal guardians and, when possible, from the child (according to ethical guidelines for pediatric research). Key exclusion criteria - Presence of severe sensory impairments (uncorrected profound hearing loss or legal blindness). Concurrent participation in other interventional studies targeting motor or social skills. Recent orthopedic injuries or surgeries affecting mobility in the past 6 months. Intellectual disability (IQ < 70) with significant adaptive functioning deficits that prevent comprehension of simple instructions. History of aggressive behavior that poses safety risks during group activities. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 13 Day Date of IRB - 2025 Year 08 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 05 Day Last follow-up date - 2025 Year 11 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068295

Disclaimer: Curated by HT Syndication.