NCT03195244已完成不适用
Aquatic Therapy and Autism Spectrum Disorders
Sloan W. Rush, MD2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in PedsQL Score
研究概览
简要总结
To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria:
- •DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD
- •Treatment naïve to prior aquatic therapy
排除标准
- •Not willing to undergo an investigational treatment
- •Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
- •Known allergies to pool chemicals
- •Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment
结局指标
主要结局
Change in PedsQL Score
时间窗: Baseline and 10 weeks after intervention
Survey
次要结局
未报告次要终点
研究者
Sloan W. Rush, MD
MD
Panhandle Eye Group, LLP
研究点 (2)
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