Effect of Upper and Lower Limb-Specific Sensorimotor Exercises on Executive Function of Children with ADHD: A four-arm Randomized Controlled Trial (SEADHD Trial)

Kazi Md Azman Hossain1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2025年8月18日最近更新: 2025年8月1日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 160
试验地点: 1
主要终点: Executive Function

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This four-arm randomized controlled trial, titled the SEADHD Trial, aims to evaluate the effects of upper limb, lower limb, and combined sensorimotor exercises on executive function in children aged 6–13 years with ADHD. Participants are randomly assigned to one of three intervention groups—Upper Limb Sensorimotor Exercise (ULSE), Lower Limb Sensorimotor Exercise (LLSE), or Upper and Lower Limb Sensorimotor Exercise (ULLSE)—each delivered over 24 structured sessions across 8 weeks, or to a control group receiving usual care. Each exercise program progressively enhances motor skills, coordination, and cognitive engagement through tailored, phase-wise activities. The primary outcomes include measures of executive function (inhibitory control, working memory, cognitive flexibility, and behavioral regulation), while secondary outcomes assess social behavior, ADHD symptoms, physical activity, affective state, and program adherence. This study seeks to provide evidence on the efficacy of sensorimotor interventions in improving executive functioning and behavior in children with ADHD.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 6.00 Year(s) 至 13.00 Year(s)（—）
性别: All

入选标准

•Participants will be included if: (1) children aged between 6 and 13 years; (2) have a clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) confirmed by a qualified developmental pediatrician, clinical psychologist, or psychiatrist; (3) possess an intelligence quotient (IQ) score above 80, as measured by the Wechsler Intelligence Scale for Children (WISC); and (4) have a formal recommendation for participation from a licensed physician or psychologist.

排除标准

•Participants will be excluded if: (1) diagnosis of any major neurodevelopmental or psychiatric disorder, such as autism spectrum disorder, intellectual disability, or cerebral palsy; (2) presence of acute or chronic medical conditions that may limit or prevent participation in physical activity; (3) a history or tendency of experiencing seizures or convulsions; (4) documented drug dependence prior to the intervention; or (5) inability to perform the physical activities involved in the intervention or difficulty in following instructions.