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临床试验/CTRI/2024/07/070209
CTRI/2024/07/070209Not Applicable不适用

Efficacy of Combined Therapy for Children with Autism Spectrum Disorder

Md Sherajul Haque1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
70
试验地点
1
主要终点
Behavioral Status

研究概览

简要总结

We plan to conduct a five-week randomized controlled trial to evaluate the efficacy of combined regular therapy (physical therapy [PT], occupational therapy [OT], and speech-language therapy [SLT]) compared to specific therapy (OT and SLT) in children with autism spectrum disorder (ASD). Participants, aged 3-22 years, will be randomly assigned to one of two intervention groups: combined regular therapy (PT+OT+SLT) or specific therapy (OT+SLT). The interventions will be administered thrice a week over the five weeks. The study will involve within-group analysis to assess improvements from baseline in each group, focusing on motor skills, coordination, physical fitness, and overall functional abilities. Additionally, between-group comparisons will be conducted to determine the relative efficacy of combined regular therapy versus specific therapy. The primary outcome measure will be the improvement in motor skills, with secondary outcomes including enhancements in coordination, physical fitness, and functional abilities. Data will be collected at baseline and post-intervention, and statistical analyses will be performed to evaluate the results. This trial aims to provide evidence of the benefits of combined therapy approaches for children with ASD.

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
3.00 Year(s) 至 22.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed as Autism Spectrum Disorder children based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
  • Willing to participate.

排除标准

  • Respondents provided consent but dropped out within the first week of enrollment
  • Severe behavioral problems according to the Gilliam Autism Rating Scale (GARS-3)
  • Other children with neurodevelopmental disorders.

结局指标

主要结局

Behavioral Status

时间窗: 1 Month

次要结局

  • Physical and Emotional health problems(1 Month)

研究者

发起方
Md Sherajul Haque
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Md Sherajul Haque

Jashore University of Science and Technology (JUST)

研究点 (1)

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