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临床试验/NCT05131347
NCT05131347已完成不适用

Effects of a Motor Intervention Program on Motor Skills and Adaptive Functions for Children With Autism Spectrum Disorder

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form

研究概览

简要总结

The study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Children in the treatment group will receive a 8-week motor skill intervention program. Children in the control group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Outcome measurements will consist of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and Vineland Adaptive Behavior Scales-Third Edition. A two-factor mixed design ANOVA will be conducted to compare pre- and post-tests differences in the treatment and control groups. The findings of the proposed study will be useful for occupational therapists and clinicians to assist caregivers in implementing the intervention program and will contribute to knowledge regarding the effects of motor intervention program on increasing the motor skills of young children with ASD in Taiwan. Practitioners can design a standard treatment manual and provide information for implementing the motor intervention program. The expected results will help clinicians apply empirical knowledge to provide and promote the health and development of young children with ASD.

详细描述

Introduction

Preschool children with autism spectrum disorder may have motor difficulties in performing daily activities. Therefore, effective and economical interventions are very important to support them. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's motor performance. Aim: This study will implement a dose-matched control group and comprehensive measurements to examine if the motor skill intervention program will improve children's motor performance. Hypotheses: The hypothesis will be that the better improvements would show in the motor skill intervention program than those in the cognitive training program. Method: Thirty preschool children with autism spectrum disorder will be recruited and randomly assigned to either the motor skill intervention program group or the cognitive training program group after pretest phase. Both groups will conduct 8-week intervention programs and be assessed after interventions. Children's motor performance will be assessed by the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and the Vineland Adaptive Behavior Scales.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosed with ASD by registered pediatric psychiatrists according to the Diagnostic and Statistical Manual-5th Edition
  • aged 48 to 71 months old
  • had no sensory impairments, such as visual or hearing impairments

排除标准

  • diagnosed with additional diseases, comorbidities, or presence of other disorders, such as epilepsy, attention deficit hyperactivity disorder (ADHD), or Fragile X syndrome
  • children with physical disabilities caused by head injuries, or neurological disorders
  • the inability to follow researcher's instructions and complete the research procedures

结局指标

主要结局

Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form

时间窗: 8 weeks

The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form uses a subtest and composite structure that highlights motor performance in the broad functional areas of stability, mobility, strength, coordination, and object manipulation. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe motor performance. The higher the scores are, the better performance the children achieve.

Vineland Adaptive Behavior Scales-Third Edition

时间窗: 8 weeks

The Vineland Adaptive Behavior Scales-Third Edition (VABS-3) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling-Yi Lin

Associate Professor

National Cheng Kung University

研究点 (2)

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